Biotechnology Books

William J. Thieman taught biology at Ventura College for 40 years and biotechnology for 11 years before retiring from full time teaching in 2005. He continues to serve as an advisor to the college biotechnology program. He received his B.A. in biology from California State University at Northridge in 1966 and his M.A. degree in Zoology in 1969 at UCLA. In 1995, he started the biotechnology program at Ventura College. In 1998, he added the laboratory skills course, and it was articulated as a state-approved vocational program. He identified technical skills needed for the program while serving three summer internships at Amgen, Biosource (now Invotrogen) and Biopool. The internships provided an opportunity to learn protocols, interact with lab directors, and query technicians, focusing on identifying the skills needed in these biotechnology companies. He routinely engaged his contacts at these biotechnology companies to lead lab protocols and describe their experienc

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Book SynopsisWhat existential threats does humanity face? And how can we secure our future? ‘The Precipice is a powerful book . . . Ord’s love for humanity and hope for its future is infectious’ Spectator ‘Ord’s analysis of the science is exemplary . . . Thrillingly written’ Sunday Times We live during the most important era of human history. In the twentieth century, we developed the means to destroy ourselves – without developing the moral framework to ensure we won't. This is the Precipice, and how we respond to it will be the most crucial decision of our time. Oxford moral philosopher Toby Ord explores the risks to humanity's future, from the familiar man-made threats of climate change and nuclear war, to the potentially greater, more unfamiliar threats from engineered pandemics and advanced artificial intelligence. With clear and rigorous thinking, Ord calculates the various risk levels, and shows how our own time fits within the larger story of human history. We can say with certainty that the novel coronavirus does not pose such a risk. But could the next pandemic? And what can we do, in our present moment, to face the risks head on? A major work that brings together the disciplines of physics, biology, earth and computer science, history, anthropology, statistics, international relations, political science and moral philosophy, The Precipice is a call for a new understanding of our age: a major reorientation in the way we see the world, our history, and the role we play in it.Trade ReviewToby Ord is today’s Carl Sagan. Clear and inspiring, this book leaves us hopeful for a flourishing human future -- Christine Peterson, co-founder of the Foresight InstituteA powerfully argued book that alerts us to what is perhaps the most important – and yet also most neglected – problem we will ever face -- Peter Singer, author of 'Animal Liberation' and 'The Life You Can Save'The Precipice separates science from hype and will remain the definitive work on existential risk for a long time to come -- Max Tegmark, author of 'Life 3.0' and 'Our Mathematical Universe'A fascinating and persuasive guide to the most important topic of all: how our species will survive the risks we pose to our continued existence -- Stuart Russell, author of 'Human Compatible' and 'Artificial Intelligence: A Modern Approach'This book is a wake-up call to the existential threats of nuclear and biological weapons and the urgent need for action. A must-read that galvanises us to play a role in addressing these risks -- Angela Kane, former UN High Representative for Disarmament AffairsHumanity has never been more vulnerable – there’s now a one-in-six chance that civilisation won’t make it to the end of the century, argues a highly influential philosopher . . . Ord’s analysis of the science is exemplary . . . Thrillingly written * Sunday Times *Many people have recently found that they want to read books offering the grandest perspectives possible on human existence, such as Sapiens . . . Toby Ord’s new book is a startling and rigorous contribution to this genre that deserves to be just as widely read * Evening Standard *Splendid . . . The Precipice is a powerful book, written with a philosopher’s eye . . . Ord’s love for humanity and hope for its future is infectious * Spectator *Urgent and vaguely prophetic . . . In a year in which our everyday lives were upended by the unexpected (or rather the expected yet neglected), The Precipice is a good way to put everything in perspective -- Books of the Year * WIRED *The Precipice is a fascinating book, one that showcases both the knowledge of its author and his humanity * Axios *A book that seems made for the present moment * New Yorker *A story of the greatest risks to humanity’s future, from the climate crisis and nuclear war to pandemics and artificial intelligence -- Highlights for 2020 * Guardian *

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Book SynopsisToday's synthetic biologists are in the early stages of engineering living cells to help treat diseases, sense toxic compounds in the environment, and produce valuable drugs. With this manual, you can be part of it.

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Book SynopsisBiotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.Trade Review“Overall, this book provides a valuable resource that can be utilized as a quick look-up guide and, more importantly, as an educational tool that can be used in strategic planning. The presentation style provides comprehensive information amenable to a diverse audience.” (Clinical Infectious Diseases, 30 October 2014)Table of ContentsContributors xiii Foreword xv Preface xvii Preface to the First Edition xix Acknowledgments xxi Organization of the Book xxiii User Agreement xxv Part I Transforming Proteins and Genes into Drugs—The Science and the Art 1 1 Introduction to Biopharmaceuticals 3 Abstract 3 1.1 Background and Significance 4 1.2 Translation of Biotechnology for Developing Biopharmaceuticals 7 1.3 Historical Perspective of Pharmaceutical Biotechnology 8 1.4 Distinctions between Chemical Drugs Versus Biopharmaceuticals 8 1.5 Summary 10 2 Distinctions of Biologic Versus Small Molecule Platforms in Drug Development 13 Abstract 13 2.1 Introduction 14 2.2 Transforming New Molecules into Drugs: The Drug Development Process 14 2.3 Key Differences between Biotechnology and Chemical Products 16 2.4 Current Trends in Drug Development 18 2.5 Summary 22 3 Financing Biologic Drug Development 23 Abstract 23 3.1 Introduction 24 3.2 The Role of the Orphan Drug Act 27 3.3 Clinical Leverage Strategy in Accelerating Drug Development 30 3.4 Therapeutic Target Considerations 32 3.5 Evolving Trends 34 3.6 Summary 36 4 Application of Biotechnology in Drug Discovery and Early Development 39 Abstract 39 4.1 Introduction 40 4.2 Data Mining, Molecular Cloning, and Characterization 40 4.3 Optimization of Cell Expression Systems and Product Yield 50 4.4 Molecular Optimization 51 4.5 Proteins and Genes as Targets for Drug Discovery and Development 56 4.6 Summary 58 5 Large-Scale Production of Recombinant Proteins 63 Abstract 63 5.1 Introduction 64 5.2 Yield Optimization in Genetic Constructs and Host Cells 65 5.3 Large-Scale Cultivation of Host Cells 66 5.4 Downstream Processing and Purification 70 5.5 Quality Assurance and Quality Control 75 5.6 Summary 77 6 Clinical Pharmacology, Toxicology, and Therapeutic Dosage and Response 79 Abstract 79 6.1 Introduction 80 6.2 Clinical Pharmacology and Toxicology 80 6.3 Dose and Therapeutic Response 95 6.4 Dosage Form and Route of Administration 97 6.5 Summary 99 7 Clinical Evaluation and Regulatory Approval and Enforcement of Biopharmaceuticals 103 Abstract 103 7.1 Introduction: Biologic Drug Development and Approval 104 7.2 Licensing of Biological Products 104 7.3 Preclinical and Clinical Testing 107 7.4 FDA Review and Approval Process 114 7.5 Regulatory Enforcement 118 7.6 Globalization of Drug Approval (Chien*) 118 7.7 Summary 122 8 Pharmacoeconomics and Drug Pricing (Garrison*) 125 Abstract 125 8.1 Introduction: Pharmacoeconomics 126 8.2 Cost-Effectiveness: Assessing the Value of Biopharmaceuticals 126 8.3 The Cost of Developing Biopharmaceuticals 128 8.4 Pricing Biopharmaceuticals 131 8.5 Drug Development Incentives 133 8.6 Economics of Biosimilars 133 8.7 Economic Impact of Personalized Medicine 134 8.8 Summary and Future Challenges 135 Part II Therapeutic and Clinical Applications of Biopharmaceu ticals—Proteins and Nucleic Acids 137 9 Antibodies and Derivatives 139 Abstract 139 Section One 140 9.1 Molecular Characteristics and Therapeutic Applications 140 9.1.1 Introduction 140 9.1.2 Historical Perspective—Discovery, Classification, Biodistribution, and Physiological Characteristics of Antibody Molecules 140 9.1.3 Gamma Globulin and Hyperimmune Globulin 144 9.1.4 Monoclonal Antibodies—From Mouse, Mouse-Human Chimeric, Humanized, to Human Monoclonal Antibodies 145 9.1.5 Antibody Derivatives 147 9.1.6 Disposition of Antibodies 149 9.1.7 Extravascular Tissue Penetration 155 9.1.8 Mechanisms of Antibody Bioactivities 156 9.1.9 Antibody Conjugates 156 9.1.10 Antibodies and Derivatives in Development 158 9.1.11 Summary 159 Section Two 162 9.2 Antibodies and Derivatives Monographs List 162 9.3 Antibodies and Derivatives Monographs 163 10 Hematopoietic Growth and Coagulation Factors 211 Abstract 211 Section One 212 10.1 Molecular Characteristics and Therapeutic Applications 212 10.1.1 Introduction 212 10.1.2 Hematopoietic Growth and Coagulation Factors 212 10.1.3 Therapeutic Use of Hematopoietic Growth Factors (Molineux, Elliott*) 218 10.1.4 Therapeutic Use of Coagulation and Anticoagulation Factors 225 10.1.5 Summary 229 Section Two 231 10.2 Hematopoietic Growth and Coagulation Factors List 231 10.3 Hematopoietic Growth and Coagulation Factors Monographs 231 11 Cytokines and Interferons 251 Abstract 251 Section One 252 11.1 Molecular Characteristics and Therapeutic Applications 252 11.1.1 Introduction 252 11.1.2 Interleukins as Immunotherapeutics 252 11.1.3 Interferon Biology and Cancer Therapy (Tiu, Koon, Borden*) 256 11.1.4 Interferons as Antiviral Therapy 271 11.1.5 Interferons in Multiple Sclerosis 275 11.1.6 Summary 280 Section Two 288 11.2 Cytokines and Interferons Monographs List 288 11.3 Cytokines and Interferons Monographs 288 12 Hormones 307 Abstract 307 Section One 308 12.1 Molecular Characteristics and Therapeutic Applications 308 12.1.1 Introduction 308 12.1.2 Peptide Hormones and Clinical Significance 308 12.1.3 Therapeutic Application of Recombinant and Synthetic Hormones 309 12.1.4 Summary 318 Section Two 320 12.2 Hormones Monographs List 320 12.3 Hormones Monographs 320 13 Enzymes 357 Abstract 357 Section One 358 13.1 Molecular Characteristics and Therapeutic Applications 358 13.1.1 Introduction 358 13.1.2 Enzyme Replacement Therapy 359 13.1.3 Enzymes as Therapeutic Agents 365 13.1.4 Summary and Future Prospects 368 Section Two 370 13.2 Enzymes Monographs List 370 13.3 Enzymes Monographs 370 14 Vaccines (Hu, Ho*) 389 Abstract 389 Section One 390 14.1 Molecular Characteristics and Therapeutic Applications 390 14.1.1 Vaccines and Their Impact on Human Health 390 14.1.2 How Vaccines Work: Interplay among Immune System, Diseases, and Vaccines 393 14.1.3 Traditional Vaccine Approaches 394 14.1.4 Subcellular and Recombinant Subunit Vaccines 395 14.1.5 Vaccine Adjuvants 398 14.1.6 Mode and Route of Vaccine Delivery 400 14.1.7 Future Directions 403 14.1.8 Summary 405 Section Two 409 14.2 Vaccines Monographs List 409 14.3 Vaccines Monographs 409 15 Other Biopharmaceutical Products 417 Abstract 417 15.1 Other Biopharmaceutical Products Monographs List 418 15.2 Other Biopharmaceutical Products Monographs 418 Part III Future Directions 425 16 Advanced Drug Delivery 427 Abstract 427 16.1 Introduction 428 16.2 Drug Therapeutic Index and Clinical Impact 429 16.3 Routes of Therapeutic Protein Administration 430 16.4 Physiological and Mechanistic Approaches 436 16.5 Approaches Using Devices 458 16.6 Molecular Approaches 460 16.7 Summary 465 17 Advances in Personalized Medicine: Pharmacogenetics in Drug Therapy 471 Abstract 471 17.1 Introduction to Interindividual Variation 472 17.2 Historical Perspective on Pharmacogenetics in Drug Safety and Efficacy 473 17.3 Pharmacogenetics in Drug Disposition and Pharmacokinetics 478 17.4 Pharmacogenetics in Drug Effects and Pharmacodynamics 483 17.5 Individualized Gene-Based Medicine: A Mixed Blessing 487 17.6 Current and Future Prospects of Pharmacogenetics 490 17.7 Summary 492 18 Gene and Cell Therapy 495 Abstract 495 18.1 Overview 496 18.2 General Strategies in Gene and Cell Therapy 499 18.3 Gene and Cell Therapy for Select Medical Conditions 501 18.4 Gene Therapy Research, Development, and Clinical Use (Sullivan*) 506 18.5 Stem Cells in Regenerative Medicine and Diagnostics (Kelly*) 509 18.6 Summary 513 19 Integration of Discovery and Development: The Role of Genomics, Proteomics, and Metabolomics 517 Abstract 517 19.1 Overview 518 19.2 Integration of Discovery and Development of Therapeutic Candidates 520 19.3 Genomics: The First Link between Sequences and Drug Targets 521 19.4 Proteomics: From Sequences to Functions 524 19.5 Metabolomics: Metabolic Profile Elucidation 528 19.6 Integrating Genomic, Proteomic, and Metabolomic Tools to Accelerate Drug Development 530 19.7 Summary 532 20 Pharmacoeconomics, Outcome, and Health Technology Assessment Research in Drug Development 535 Abstract 535 20.1 Introduction: Health-Care Decisions and Health Outcomes 536 20.2 Integration of Pharmacoeconomic Outcome Research in Clinical Drug Development 538 20.3 Regional Differences in the Type of Evidence and Value Data Essential for Health-Care and Reimbursement Decisions 541 20.4 Biopharmaceutical Company Strategies 542 20.5 Summary 545 20.6 Acknowledgments 546 21 Future Prospects 547 Abstract 547 21.1 Progress and Benefits in Transforming Proteins and Genes into Biopharmaceuticals 548 21.2 Genomic Information Improves Safety and Production Cost of Biopharmaceuticals 548 21.3 The Business of Biopharmaceuticals and Economic Impacts 549 21.4 Influence of Biopharmaceuticals on Pharmaceutical Research, Development, and the Drug Industry 549 21.5 Public–Private Partnership in Financial and Regulatory Support to Improve Translational Success 550 21.6 Biopharmaceuticals and Public Health Benefits 551 21.7 Public Participation and Influence on Biopharmaceutical Development 551 21.8 Outlook 552 Appendix I. Dosage Form, Pharmacokinetics, and Disposition Data 555 Appendix II. Molecular Characteristics and Therapeutic Use 581 Appendix III. Nomenclature of Biotechnology Products 617 Appendix IV. Other Information 621 Index 633 Color plate section is located between pages 210 and 211.

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Book SynopsisGrossly ambitious and rooted in scientific scholarship, The Other Dark Matter shows how human excrement can be a life-saving, money-making resource—if we make better use of it.Trade Review"A take on waste that's anything but wasteful—it's a fascinating dig into the history and science of handling human excrement. . . . Equally remarkable are Zeldovich's sections on the development and evolution of wastewater treatment plants. . . . Zeldovich is at home with an awkward subject, making for a grossly engrossing and vivid survey. Readers won't take the 'flush and forget' mindset for granted again." * Publishers Weekly *"Zeldovich is an engaging writer. She loves puns and poop jokes. (Who doesn't?) And her travels around the world are, in their own scatological way, inspiring." -- Elizabeth Kolbert * New York Review of Books *"[An] original, necessary book." * Nature *"It would be easy for a book that focuses on obstacles to improving global sanitation, fixing the agricultural waste cycle, reducing pollution, and improving health to resort to paralyzing gloom. The Other Dark Matter does not shy from the enormity of the problems, yet suggests solutions are achievable, at scales from individuals to entire countries. Paced quickly with prose enlivened by the author's on-location reporting and personal experiences, the book is far from a grim slog through the world's sewers—it's more like an exciting tour in a biogas-powered balloon." * Undark *"The Other Dark Matter does not shy from the enormity of the problems, yet suggests solutions are achievable, at scales from individuals to entire countries. Paced quickly with prose enlivened by the author's on-location reporting and personal experiences, the book is far from a grim slog through the world's sewers — it's more like an exciting tour in a biogas-powered balloon." * Salon *"It's unusual to come across a book that makes you say, 'Oh, crap!' in a good way." * American Scientist *“In bright and airy prose, she takes readers on a globe-spanning trip to sites where fecal material is reprocessed and figuratively turned into gold. . . . Readers should leave this book with a renewed interest in sustainable systems to manage what we normally put out of sight and out of mind." * Natural History *“It is unquestionably [a topic] that—given the ever-increasing human population belaboring the planet—merits our attention if we are, ecologically and sustainably speaking, to prevent finding ourselves collectively up a famous creek without a propulsion device. Ms. Zeldovich’s new book looks to be an excellent way to introduce ourselves to it.” * The Well-Read Naturalist *"Given the growing scale of public engagement in sanitation, there is a glut of books on the subject. Not all of them are readable, not all of them are well researched. This one is. It takes the technology questions further. It is an engaging read on a queasy topic" * Shaastra *"In writing a primer on poop and its possibilities, [Zeldovich] performs a much larger function: destigmatizing a vital biological product that has long gotten a bum rap." * Columbia Magazine *"Some of the ideas in [the book] really feel like they could change the world in a major way. . . . It's really excellent." * Across the Margin *"Even readers familiar with the history and ecology of waste management will not be disappointed. . . . As detailed as it is witty. . . . Given the growing scale of public engagement in sanitation, there is a glut of books on the subject. Not all of them are readable, not all of them are well researched. This one is. It takes the technology questions further. It is an engaging read on a queasy topic." * Shaastra *"This is some good shit, people. Not only entertaining, but deeply important. Everyone with a colon should read this book. Centuries back, people knew the value of shit. In countries with poor soil, human waste was like gold: people stole it, paid their rent with it, and gave it as gifts. Today, keeping it out of our waterways is our best hope for defusing what Zeldovich calls the Great Sewage Time Bomb. She is an ideal guide to this ridiculously fascinating world." -- Mary Roach, author of Stiff: The Curious Lives of Human Cadavers"Zeldovich shows to dazzling effect how a famously difficult subject—the often peculiar scientific history of human waste—can become an engrossing tale. The story is enlightening, surprising, occasionally enraging—and wholly worth your time." -- Deborah Blum, Pulitzer Prize–winning author of The Poison Squad"Zeldovich shows that excrement can be useful, profitable, and anything but waste, and does this with warmth, curiosity, and humor. This book is a great companion should you wish to journey to the rich and still underexposed world of shit (and you should)." -- Rose George, author of The Big Necessity: The Unmentionable World of Human Waste and Why It Matters"Here is an indispensable book about what we might call the Anthro-poo-cene. Humanity's current collision course with nature has everything to do with energy and how we abuse it—including the human waste products of our metabolic bodies. This lively and entertaining history is also full of innovative ways people are finally dealing with their you-know-what." -- Mary Ellen Hannibal, author of Citizen Scientist: Searching for Heroes and Hope in an Age of Extinction"Who knew our poop could be so fascinating and important? In her brilliantly reported and written new book, Zeldovich shows that now more than ever the health of humanity and the rest of nature depends on how we handle 'the other dark matter.'" -- John Horgan, author of Pay Attention: Sex, Death, and Science"An intriguing, compelling, very human story of how a valuable resource has been used and squandered, thrown away, and rediscovered. It is a story of the people who, against a background of mockery and disbelief, have developed creative, lucrative, and ecologically viable options for reframing what many have seen as a 'problem' of 'waste disposal' into an opportunity for innovative resource use. It will have wide appeal to all intelligent readers, both within and well beyond academia." -- David Waltner-Toews, author of The Origin of Feces: What Excrement Tells Us About Evolution, Ecology, and a Sustainable SocietyTable of ContentsPart 1: The History of Human Waste Chapter 1: How I Learned to Love the Excrement Chapter 2: The Early History of Human Excreta Chapter 3: Treasure Night Soil as if It Were Gold! Chapter 4: The Water Closet Dilemma and the Sewage Farm Paradigm Chapter 5: Germs, Fertilizer, and the Poop Police Part 2: The Present: A Sludge Revolution in Progress Chapter 6: The Great Sewage Time Bomb and the Redistribution of Nutrients on the Planet Chapter 7: Loowatt, a Loo That Turns Waste into Watts Chapter 8: The Crap That Cooks Your Dinner and Container-Based Sanitation Chapter 9: HomeBiogas: Your Personal Digester in a Box Chapter 10: Made in New York Chapter 11: Lystek, the Home of Sewage Smoothies Chapter 12: How DC Water Makes Biosolids BLOOM Chapter 13: From Biosolids to Biofuels Part 3: The Future of Medicine and Other Things Chapter 14: Poop: The Best (and Cheapest) Medicine Chapter 15: Looking where the Sun Doesn’t Shine Chapter 16: From the Kindness of One’s Gut: An Insider Look into Stool Banks Afterword: Breathing Poetry into Poop Notes Index

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Book SynopsisThe 'bioeconomy' is the idea of an economy based on the sustainable exploitation of biological resources. Within this concept, there is increasing emphasis on issues such as climate change, depletion of natural resources and growing world food needs. The bioeconomy builds on the recognition of advances in technology, particularly in the life sciences, but at the same time covers issues such as innovation management, ecosystem services, development and governance. This book explores the development of the bioeconomy across the world from an economic and policy perspective, as well as identifying potential future pathways and issues. It uses a broad definition, covering all sectors using biological resources except health, and rather than focusing on individual sectors, it explores the breadth of interconnections that make the bioeconomy a new and challenging subject. Divided into two parts, the book initially outlines the current definitions, strategies, policy and economic information related to the world's bioeconomy. The second part describes current economic analysis and research efforts in qualifying and understanding the economics of the bioeconomy. This includes the contributions of technology, research and innovation; driving forces and demand-side economics; supply-side economics, and the role of markets and public policy in matching demand and supply. The political economy, regulation and transitions are considered, as well as the contribution of the bioeconomy to society, including growth, development and sustainability. Key features include: - An analysis of varied international approaches to the bioeconomy. - A joint consideration of biotechnology, agriculture, food energy and bio-materials. - An assessment of sustainability in the bioeconomy. - A comprehensive view of the issues from an economic and policy perspective. This book will be of interest to students and researchers in agricultural and natural resource economics, agricultural and environmental policy, as well as policy-makers, practitioners and economists.Table of Contents1: Introduction and Overview 2: What is the Bioeconomy 3: Technology and Innovation in the Bioeconomy 4: Approaches to (the Economics of) the Bioeconomy 5: Driving Forces and Demand-side Economics 6: Supply-side Economics 7: Matching Demand and Supply: Markets, Policies and Beyond 8: The Political Economy of the Bioeconomy, Regulation, Public Policy and Transition 9: The Bioeconomy and Sustainable Development 10: Impact Evaluation and Management Tools 11: At the Boundary of Economics 12: Final Thoughts and Outlook

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Book SynopsisComputational Chemistry Methodology in Structural Biology and Materials Sciences provides a selection of new research in theoretical and experimental chemistry, focusing on topics in the materials science and biological activity. Part 1, on Computational Chemistry Methodology in Biological Activity, of the book emphasizes presents new developments in the domain of theoretical and computational chemistry and its applications to bioactive molecules. It looks at various aspects of density functional theory and other issues. Part 2, on Computational Chemistry Methodology in Materials Science, presents informative new research on computational chemistry as applied to materials science. The wide range of topics regarding the application of theoretical and experimental chemistry and materials science and biological domain will be valuable in the context of addressing contemporary research problems. Table of ContentsStudy of pKa Values of Alkylamines Based on Density Functional Theory. A DFT Investigation of the Influence of Α, Β Unsaturation in Chemical Reactivity of Coumarin and Some Hydroxy Coumarins. Molecular Determinants of TRPC6 Channel Recognition by FKBP12. In Silico Design of PDHK Inhibitors: From Small Molecules to Large Fluorinated Compounds. The Smart Cyberinfrastructure: Space-Time Multiscale Approaches for Research and Technology. Application of Computational Methods to the Rational Design of Photoactive Materials for Solar Cells. Theoretical Studies on Adsorption of Organic Molecules on Metal Surface. A Comparative Theoretical Investigation on the Activation of C-H Bond in Methane on Mono and Bimetallic Pd and Pt Subnanoclusters. Theoretical Analysis: Electronic and Optical Properties of Small Cu-Ag Nano Alloy Clusters. Multisolitons in SRR Based Metamaterials in Klein-Gordon Lattice. Ab-Initio Techniques for Light Matter Interaction at the Nanoscale. Synthesis and Characterization of Multi-Component Nanocrystalline High Entropy Alloy.

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Book SynopsisNATIONAL BESTSELLER • The gripping story of Elizabeth Holmes and Theranos—one of the biggest corporate frauds in history—a tale of ambition and hubris set amid the bold promises of Silicon Valley, rigorously reported by the prize-winning journalist. With a new Afterword covering her trial and sentencing, bringing the story to a close.“Chilling ... Reads like a thriller ... Carreyrou tells [the Theranos story] virtually to perfection.” —The New York Times Book ReviewIn 2014, Theranos founder and CEO Elizabeth Holmes was widely seen as the next Steve Jobs: a brilliant Stanford dropout whose startup “unicorn” promised to revolutionize the medical industry with its breakthrough device, which performed the whole range of laboratory tests from a single drop of blood. Backed by investors such as Larry Ellison and Tim Draper, Theranos sold shares in a fundraising round that valued the company at more than $9 billion, putting Holmes’s worth at an estimated $4.5 billion. There was just one problem: The technology didn’t work. Erroneous results put patients in danger, leading to misdiagnoses and unnecessary treatments. All the while, Holmes and her partner, Sunny Balwani, worked to silence anyone who voiced misgivings—from journalists to their own employees.

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Book SynopsisTable of ContentsPart 1: Materials Science and Engineering Section 1.2 Properties of Materials Section 1.3 Classes of Materials Used in Medicine Section 1.4: Materials Processing Part 2: Biology and Medicine Section 2.1 Some Background Concepts Section 2.2 Host Reaction to Biomaterials and Their Evaluation Section 2.3 Characterization of Biomaterials Section 2.4 Degradation of Materials in the Biological Environment Section 2.5 Applications of Biomaterials Section 2.6 Applications of Biomaterials in Functional Tissue Engineering Part 3: The Medical Product Life Cycle Appendix A: Properties of Biological Fluids Appendix B: Properties of Soft Materials Appendix C: Chemical Composition of Metals and Ceramics Used for Implants Appendix D: The Biomaterials Literature Appendix E: Assessment of Cell and Matrix Components in Tissues (Online only)

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Book SynopsisTable of ContentsUnit I – The cell 1. An introduction to biotechnology 2. Voyage into the cell 3. Proteins 4. Genes: the blueprints for proteins 5. Cell growth Unit II – Biotechnology in the laboratory 6. Microbial killing 7. Cell culture and the eukaryotic cells used in biotechnology 8. Fluorescence 9. Agarose gels 10. The polymerase chain reaction (PCR) 11. Genetic engineering Unit III – Biotechnology in the real world 12. Gene delivery 13. RNAi 14. Genome editing 15. DNA fingerprinting 16. Fermentation, beer, and biofuels 17. Stem cells, tissue engineering, and regenerative medicine 18. Transgenics and genetically modified organisms in agriculture 19. Patents and licenses

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Book SynopsisTable of Contents1. Social dimensions and preconditions of digitalization in healthcare: Implications of the COVID-19 syndemic2. Digital Innovation for Healthcare in COVID-19 Pandemic3. A digital health ecosystem for Africa during the Covid-19 pandemic4. Doctor New perspectives on telemedicine for women during the COVID pandemic5. Implementing Virtual Patient Rooming during Telemedicine Visits6. Embracing Digital Technologies In The Healthcare Setting7. Impact of COVID-19 on the Adoption of Digital Pathology8. The COVID-19 pandemic in an interdependent world: Digital health as a tool for equity and gender empowerment9. The Study of the Dilemma on the Control of Covid-19 Spread and Face-To-Face Learning and Its Trade-Off Solutions10. Digital tools for direct and indirect citizen empowerment: The retaliatory response against Covid - 19 in India11. Continuum of Care through Patient Relationship Management Approach in Indian Public Healthcare System' 12. Using Machine Learning Methods to Understand COVID-19 Inpatient Medical Health Records in a US Hospital System13. Geospatial analysis of COVID-19 distribution and its relation to public transportation services14. M-Health System for cardiac and COVID patient monitoring using Body Sensor Networks and Machine Learning15. Pandemic-driven innovations contribute to the development of information-based medicine16. Enabling Healthcare 4.0 Applications Development Through a Middleware Platform17. Healthcare 4.0 Significance and Benefits Affirmed by the COVID-19 Pandemic18. Improving the diagnostic accuracy using Amplification and sequencing of the SARS-CoV-2 genome19. Telecardiology COVID-19 Cryptographic System: Security Reinforcement Through Metaheuristics and Artificial Neural Networks 20. The use of digital technologies in the response to SARS-2 CoV2-19 in the public health sector

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Book SynopsisTable of Contents1. A deep learning approach for the prediction of heart attacks based on data analysis 2. A comparative study on fully convolutional networks—FCN-8, FCN-16, and FCN-32: A case of brain tumor 3. Deep learning applications for disease diagnosis 4. An artificial intelligent cognitive approach for classification and recognition of white blood cells employing deep learning for medical applications 5. Deep learning on medical image analysis on COVID-19 x-ray dataset using an X-Net architecture 6. Early prediction of heart disease using a deep learning approach 7. Machine learning and deep learning algorithms in disease prediction: Future trends for the healthcare system 8. Automatic detection of white matter hyperintensities via mask region-based convolutional neural networks using magnetic resonance images 9. Diagnosing glaucoma with optic disk segmenting and deep learning from color retinal fundus images 10. An artificial intelligence framework to ensure a trade-off between sanitary and economic perspectives during the COVID-19 pandemic 11. Prediction of COVID-19 using machine learning techniques

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Book SynopsisAN INSTANT NEW YORK TIMES BESTSELLERONE OF TIME’S 100 MOST INFLUENTUAL PEOPLE IN ARTIFICIAL INTELLIGENCEThe noted inventor and futurist’s successor to his landmark book The Singularity Is Near explores how technology will transform the human race in the decades to comeSince it was first published in 2005, Ray Kurzweil’s The Singularity Is Near and its vision of an exponential future have spawned a worldwide movement. Kurzweil's predictions about technological advancements have largely come true, with concepts like AI, intelligent machines, and biotechnology now widely familiar to the public.In this entirely new book Ray Kurzweil brings a fresh perspective to advances toward the Singularity—assessing his 1999 prediction that AI will reach human level intelligence by 2029 and examining the exponential growth of technology—that, in the near future, will expand human intelligence a milli

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Book SynopsisWritten primarily for mid-to-upper level undergraduates, this primer will introduce students to topics at the forefront of the subject that are being applied to probe biological problems, or to address the most pressing issues facing society. This primer provides an overview of the challenges and opportunities of applying synthetic biological techniques to mammalian cells, tissues, and organisms.Table of Contents1: Jamie A. Davies: An introduction to mammalian synthetic biology 2: Jamie A. Davies: Special features of mammalian systems 3: Lenny Nelson and Alistair Elfick: Technologies for mammalian synthetic biology 4: Jamie A. Davies: Mammalian synthetic biology as a research tool 5: Jamie Billington, Anna Mastela, and Susan J Rosser.: Teaching mammalian cells to make new, useful things 6: Steven M. Pollard: Synthetic biology, stem cells and regenerative medicine 7: David Obree: The ethics of synthetic biology

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Book SynopsisMicrofluidics is a young and rapidly expanding scientific discipline, which deals with fluids and solutions in miniaturized systems, the so-called lab-on-a-chip systems. It has applications in chemical engineering, pharmaceutics, biotechnology and medicine. As the lab-on-a-chip systems grow in complexity, a proper theoretical understanding becomes increasingly important. The basic idea of the book is to provide a self-contained formulation of the theoretical framework of microfluidics, and at the same time give physical motivation and examples from lab-on-a-chip technology. After three chapters introducing microfluidics, the governing equations for mass, momentum and energy, and some basic flow solutions, the following 14 chapters treat hydraulic resistance/compliance, diffusion/dispersion, time-dependent flow, capillarity, electro- and magneto-hydrodynamics, thermal transport, two-phase flow, complex flow patterns and acousto-fluidics, as well as the new fields of opto- and nano-fluidTrade ReviewAn excellent text, very well written and pedagogically sound. Clear, concise, and complete, it explains the theoretical framework of microfluidics to a broad audience. * Kari Dalnoki-Veress, McMaster University, Hamilton, Ontario *Written in a highly pedagogical style. The reader, whether graduate, undergraduate or researcher will find this book extremely useful. * Patrick Tabeling, ESPCI Paris *The field is rapidly evolving to the point where it will become valuable, and indeed necessary, to do calculations to design real devices. This book offers a prescription for doing this. * David Weitz, Harvard University *Table of Contents1. Basic concepts in microfluidics ; 2. Governing equations ; 3. Basic flow solutions ; 4. Hydraulic resistance and compliance ; 5. Diffusion ; 6. Time-dependent flow ; 7. Capillary effects ; 8. Electrohydrodynamics ; 9. Electroosmosis ; 10. Dielectrophoresis ; 11. Magnetophoresis ; 12. Thermal transfer ; 13. Two-phase flow ; 14. Complex flow patterns ; 15. Acoustofluidics ; 16. Optofluidics ; 17. Nanofluidics ; Appendices

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Book SynopsisScholars and policymakers alike agree that innovation in the biosciences is key to future growth. The field continues to shift and expand, and it is certainly changing the way people live their lives in a variety of ways. With a large share of federal research dollars devoted to the biosciences, the field is just beginning to live up to its billing as a source of innovation, economic productivity and growth. Vast untapped potential to imagine and innovate exists in the biosciences given new tools now widely available. In The Biologist''s Imagination, William Hoffman and Leo Furcht examine the history of innovation in the biosciences, tracing technological innovation from the late eighteenth century to the present and placing special emphasis on how and where technology evolves. Place is often key to innovation, from the early industrial age to the rise of the biotechnology industry in the second half of the twentieth century. The book uses the distinct history of bioinnovation to discuss current trends as they relate to medicine, agriculture, energy, industry, ecosystems, and climate. Fast-moving research fields like genomics, synthetic biology, stem cell research, neuroscience, bioautomation and bioprinting are accelerating these trends. Hoffman and Furcht argue that our system of bioscience innovation is itself in need of innovation. It needs to adapt to the massive changes brought about by converging technologies and the globalization of higher education, workforce skills, and entrepreneurship. The Biologist''s Imagination is both a review of past models for bioscience innovation and a forward-looking, original argument for what future models should take into account.Trade ReviewThis exceptionally well researched and engagingly presented account of the growth of biotechnology in medicine, agriculture, manufacturing and pharmaceutical industries is a veritable tour de force. * Ben Mepham, The Biologist *Table of ContentsIntroduction ; Chapter 1: Ideas, progress, wealth, and the biological revolution ; Chapter 2: Drugs, biomolecules, brains, and the shifting currents of innovation ; Chapter 3: Regional bioinnovation: Reaping the harvest of the local ; and the global ; Chapter 4: Mendel's journey from peas to petabytes ; Chapter 5: Toning up universities for regional growth ; Chapter 6: Splicing and dicing: Property, information, and the DNA of innovation ; Chapter 7: Looking ahead as an industry evolves ; Conclusion ; Chapter endnotes ; Selected bibliography ; Acknowledgements ; Index

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Book SynopsisThe advent of recombinant DNA technology in the 1970s was a key moment in the history of both biotechnology and the commercialization of academic research. This book brings to life the hybrid origin story of biotechnology and ways the academic culture of science has changed in tandem with the early commercialization of recombinant DNA technology.Trade Review"Yi's masterwork is a welcome deep-sequencing of how the double helix, DNA, gave rise to the triple helix-university-industry-government relations at the dawn of modern biotechnology. Yi's story traces how a science department changed the world, for better or for worse, or a bit of both." (Robert Cook-Deegan, Duke University)

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Book SynopsisUsing economic models and empirical analysis, this title examines a range of agricultural and biofuel policy issues with regard to their effects on American agricultural and agrarian insurance markets.

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Book SynopsisTrade ReviewDonna Dickenson's book offers a compelling and overarching framework for interpreting new trends in biomedical science, such as gene biobanks, pharmacogenetics, and the banking of cord blood. It forces the reader to ask whether every new technological advance in medicine truly betters the field-and for whom. -- Sheldon Krimsky, Tufts University Few words have as much ethical clout these days as that of 'choice,' a word that can be construed as the centrality of 'me.' Donna Dickenson's splendid book shows how deeply the 'me' has become embedded in medicine and abetted by the seemingly unchallengeable ethical concept of autonomy. What we have lost is the importance of 'we.' Using personalized medicine as her point of departure, she brilliantly works her way through a range of recent medical developments to show the damage the dominance of 'me' can bring. Her book can help restore the 'us' that has been diminished. -- Daniel Callahan, cofounder and president emeritus of The Hastings Center and author of The Roots of Bioethics: Health, Progress, Technology, Death In this timely book, Dickenson levels trenchant criticism at the poster child of the twenty-first-century biomedical establishment: 'personalized medicine.' Analyzing an impressive array of practices in the new life sciences, she makes a persuasive argument that, as personalized medicine unfolds, market values and individualism are trumping the ideals of public health. This book comes at a critical moment. As we reappraise the social contract of health care, this book helps better direct research and development towards the common good. -- David Winickoff, University of California, Berkeley Donna Dickenson's book is a seminal philosophical examination of the enthusiastic embrace of 'personalized medicine,' questioning easy assumptions about its benefits for patient care and for public health. Dickenson sounds powerful warnings about the extent to which personalized medicine risks confusion with individual self-interest and the devotion of biotechnology for private gain. -- Leslie Francis, University of Utah, co-author of The Patient as Victim and Vector: Bioethics and Infectious Disease Recognizing that there are trade-offs in how we conceptualize medicine as either driven and developed for the common good or specialized for the individual, Dickenson offers an important examination of contemporary medicine and a beautifully written account of what is at stake when the common good is overlooked. Hands down, she is one of the most insightful contributors to law and medicine discourse, and this book is a must-read for everyone concerned about the future of biotechnology. -- Michele B. Goodwin, University of Minnesota, and editor of Baby Markets: Money and the New Politics of Creating Families If you are wondering what to make of personalized medicine's grand claims, let Dickenson be your guide. Turning her keen scientific and political intelligence to biotech visions of individually tailored drugs, consumer gene tests, enhancement technologies, and more, she finds tidbits of hope for improving health care among scads of hype-some of it dangerous. This must-read book makes a powerful case for taming market domination and 'me-centeredness' and for renewing our commitments to public health and the common good. -- Marcy Darnovsky, executive director, Center for Genetics and Society Dickenson's mapping out of this vital fork in the road is valuable. Publishers Weekly This book is filled with clearly explained, hard science, giving equal treatment to the benefits and problems of personalized medicine... I recommend expending the necessary reading effort not only for healthcare workers but for the general public. New York Journal of Books Dickenson's greatest achievement in this book is that she largely succeeds in creating a coherent, compelling narrative across the five disparate case studies and that she does so incorporating insights from a range of domains including sociology, ethics, philosophy, law and biomedicine. -- Michael Morrison New Genetics and SocietyTable of ContentsPreface 1. A Reality Check for Personalized Medicine 2. "Your Genetic Information Should Be Controlled by You": Personalized Genetic Testing 3. Pharmacogenetics: One Patient 4. "Your Birth Day Gift": Banking Cord Blood 5. Enhancement Technologies: Feeling More Like Myself 6. "The Ancient, Useless, Dangerous, and Filthy Rite of Vaccination": Public Health 7. Reclaiming Biotechnology for the Common Good Notes Bibliography Index

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Book SynopsisProgrammable Planet is a grand tour through the world of synthetic biology, telling the stories of the colorful visionaries whose ideas are shaping discoveries. Ted Anton explores the field from its beginning in fighting malaria in Africa to the COVID vaccines and beyond.Trade ReviewProgrammable Planet captures the passion and energy of those at the genesis of the construction of the genetically engineered world. -- Christopher Voigt, Daniel I.C. Wang Professor of Biological Engineering, Massachusetts Institute of TechnologyIf you’ve ever wondered about the promise—and the peril—of synthetic biology and its power to transform life, then Programmable Planet is the book for you. Ted Anton’s exploration of both the history and the future of the ways we engineer life is incisive, engaging, and downright fascinating. -- Deborah Blum, Pulitzer Prize–winning author of The Poison Squad: One Chemist’s Single-Minded Crusade for Food Safety in the Early Twentieth CenturyProgrammable Planet is a thoroughly engaging and enjoyable read. Anton is an expert storyteller who blends the human element with cutting-edge science like a synthetic biologist engineering a novel organism. Timely and at times provocative, the book provides a wonderful grounding for those interested in learning more about synthetic biology’s promise and threat. And we should all be interested in learning more. -- Aoife Brennan, president and chief executive officer, SynlogicIn this rollicking compendium, Anton documents a huge number of ways synthetic biology can be used in practice, embedding these examples in the experiences of the people involved. -- Drew Endy, Stanford UniversityTable of ContentsIntroductionPart I. Beginnings1. A Glass of Absinthe: A Malaria Medicine2. A Radical Philosophy3. Pandora’s Box: The Triumph and Temptation of Gene Editing4. The Silk Road: Directing Evolution5. Wild: Remaking LifePart II. Ripples in the Water6. Rush: Biology-Made Medicines7. New Nature: A Do-It-Yourself Environment8. Hearth and Home9. Fantastic Voyages: Mining and the Military10. The Killers: Viruses as HealersPart III. Bioindustrial Revolution11. Race to a Vaccine12. Global Production: Perils and Profits of a New Science13. The Moirai’s Gift14. To the Planets, and Beyond: Synthetic Biology in Space15. FuturamaAcknowledgmentsTimelineGlossaryFurther ReadingNotesIndex

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Book SynopsisThis volume teaches 100 ""kanji"" that appear frequently in documents dealing with biotechnology and reviews the 365 ""kanji"" presented in ""Basic Technical Japanese"". The lessons are keyed to the final ten chapters of the latter, enabling students to use the two volumes together.

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Book SynopsisWith a New AfterwordMust We Age?Nearly all scientists who study the biology of aging agree that we will someday be able to substantially slow down the aging process, extending our productive, youthful lives. Dr. Aubrey de Grey is perhaps the most bullish of all such researchers. As has been reported in media outlets ranging from 60 Minutes to The New York Times, Dr. de Grey believes that the key biomedical technology required to eliminate aging-derived debilitation and death entirely-technology that would not only slow but periodically reverse age-related physiological decay, leaving us biologically young into an indefinite future-is now within reach.In Ending Aging, Dr. de Grey and his research assistant Michael Rae describe the details of this biotechnology. They explain that the aging of the human body, just like the aging of man-made machines, results from an accumulation of various types of damage. As with m

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Book SynopsisTable of Contents1. Introduction Part I: Biomedical data formats and data integration 2. Data structures associated with biomedical research 3. Data mining and predictive analytics for cancer and COVID-19 4. Modular design, image biomarkers, and radiomics Part II: Type theory, graphs, and conceptual spaces 5. Types' internal structure and “non-constructive (“NC4”) type theory 6. Using code models to instantiate data models Part III: Conceptual spaces and graph-oriented data-modeling paradigms 7. Multi-aspect modules and image annotation 8. Image annotation as a multi-aspect case study 9. Conceptual spaces and scientific data models

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Book SynopsisTable of Contents1. Human Granulocyte proteins constitute the major antimucobactericidal proteins and enhance the killing of mycobacteria within macrophages2. Prevalence of PDR bacterial strains harbored with NDM-1 gene isolated from UTI patients Biofilm formation and antibiotic susceptibility profile in bacterial strains isolated from the patient infected with UTI3. Biofilm formation and antibiotic susceptibility profile in bacterial strains isolated from the patient infected with UTI4. A brief study of genes vital for diabetes and their relationship5. Vascular Endothelial Growth Factor: An Attractive Candidate Susceptibility Gene for Diabetic Complications in Type 2 Diabetes Mellitus Patients6. Analysing the relation between cytokine IL-2 and cytogenetic abnormalities in acquired aplastic anemia patients7. A comparative study of Arsenic exposure in human papilloma virus infection and oral squamous cell carcinoma- an alarming interpretation8. Correlation between Oral Cancer and Betel Quid: A Molecular Cytogenetics Study9. Effect of Antioxidants Trolox and Coenzyme Q10 on Glutamate Mediated Excitotoxicity of Retinal Ganglion Cells10. Therapeutic and Nodulation Properties of Cross Talking (Iso)flavonoids11. Efficacy of Green Synthesized Silver Nanoparticles (AgNP) over crude plant extract of Allium cepa and standard antibiotic against bacterial biofilms12. Effectiveness of Onion (Aleum cepa) skin in Human Health13. Application of Random Forest model in detection of Parkinson’s disease14. Computer Aided Drug design of lead compounds against Dopamine & Metabotropic glutamate receptors (metabotropic glutamate receptors 1)15. Brain tissue segmentation using Modified Fuzzy C-Means Clustering16. Tumor Detection Using Spatial Hybrid Clustering (SHCM) from Brain MRI Scans17. Identification of Potential Drug Targets by Detangling Protein-Protein Interaction Network18. Molecular Docking Studies between components of Eucalyptus Essential Oil and Homologically Modelled Target Protein19. Cryopreservation of mesenchymal stem cells (MSCs) derived from bone marrow with carbohydrate additive sucrose and dimethyl sulfoxide20. Behavioral difference of interactions between photosensitizer MC 540 and serum albumins in anionic AOT and cationic CTAB reverse micelles21. Mobile Health Monitoring for Senior Citizens using Femtolet Based Fog Network22. Analytical study on Variation of health care status in Haldia city of West Bengal, India

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Book SynopsisThis book details several important medicinal plants, their occurrence, plant compounds and their chemical structures, and pharmacological properties against various human diseases. It also gives information on isolation and structural elucidation of phytocompounds, bio-assays, metabolomic studies, and therapeutical applications of plant compounds.Table of ContentsSection 1: Medicinal plants. Gloriosa Superba, A Source Of The Bioactive Alkaloid Colchicine: Chemistry, Biosynthesis And Commercial Production. Botany, Phytochemistry And Pharmacological Activities Of Leea Species. Centella Asiatica (L.) Urb., an endowment from traditional medicine. The Importance Of Iranian Borage (Echium Amoenum Fisch. Mey): A Critical Review. Section 2: Plant metabolites and bioactive compounds. Plant Metabolites As New Leads To Drug Discovery- Approaches And Challenges. Introduction To Herbs And Their Therapeutical Potential: Recent Trends. Curcumin As A Potential Therapeutic For Alzheimer's Disease: A Multi-Targeted Approach. Black Cumin (Nigella Sativa L.): Bioactive Compounds And Health Benefits. Indian Tropical Fruits And Role Of Their Bioactive Compounds Against Human Diseases. Plant Alkaloids: Classification, Isolation And Drug Development. The Role Of Phytocompounds In Cosmeceutical Applications. Rosmarinic Acid: Sources, Properties, Applications And Biotechnological Production. Section 3: Bioactive potential of medicinal plants and treatment against diseases. Scientific Validation Of The Usefulness Of Withania Somnifera Dunal In The Prevention Of Diseases. Plant Essential Oils And Anticancer Properties: An Update. Isolation, Extraction, Preclinical And Clinical Studies On Major Anticancer Compounds Of Natural Origin. Anticancer Properties Of Medicinal Plants Listed In The Herbal Pharmacopoeia Of The United Mexican States.

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Book SynopsisThis book â a collection of reviews and research articles by the top academics in the field â provides a glimpse of the cutting-edge technology and research being carried out and shows how researchers are utilizing this knowledge to develop new areas of study and novel applications. It serves as a valuable resource while exploring the latest advances in virus particle assembly and demonstrating how the knowledge of fundamental processes has been used to advance bio-nanotechnology. Chapters detail biophysical approaches and biomotor research, discus the latest advances in DNA/RNA nanoparticle assembly and use, and introduce the use of DNA/RNA nanoparticles for drug delivery.Table of Contents1. Biological nanomotors with linear, rotation, or revolution motion mechanism. 2. Classifications and typical examples of Biomotors. 3. Structure of revolving biomotors. 4. Structure of rotation motors. 5. Structure of linear motors. 6. Mechanical Properties of Molecular Motors and the Relevance to Their Biological Function. 7. Molecular Mechanism of AAA-ATPase Motor in the 26S Proteasome. 8. General mechanism of biomotors. 9. Mechanism of revolving motors. 10. Mechanism of rotary motors. 11. Mechanism of linear motors. 12. Finding of widespread viral and bacterial revolution dsDNA translocation motors distinct from rotation motors by channel chirality and size. 13. The ATPase of the phi29 DNA packaging motor is a member of the hexameric AAA+ superfamily. 14. Arginine Finger Serving as the Starter of Viral DNA Packaging Motors. 15. Three-step channel conformational changes common to DNA packaging motors of bacterial viruses T3, T4, SPP1, and Phi29. 16. Sequence Dependence of Reversible CENP-A Nucleosome Translocation 17. Same function from different structures among pac site bacteriophage (TerS) terminase small subunits. 18. Kinetic study of the fidelity of DNA replication with higher-order terminal effects. 19. Multilevel Control of the Activity of p97/Cdc48, A Versatile Protein Segregase. 20. High resolution structure of hexameric herpesvirus DNA-packaging motor elucidates revolving mechanism and ends 20-year fervent debate. 21. Methods for Single-Molecule Sensing and Detection Using Bacteriophage Phi29 DNA Packaging Motor. 22. Instrumental design of five-dimensional single particle tracking. 23. The appropriate ratio of retroviral structural proteins is activated by the spleen necrosis virus post-transcriptional control element. 24. Translation of the long-term fundamental studies on viral DNA packaging motors into nanotechnology and nanomedicine. 25.Translocation of Peptides through Membrane-Embedded SPP1 Motor Protein Nanopores 26. Insertion of channel of phi29 DNA packaging motor into polymer membrane for high-throughput sensing. 27.Engineering of protein nanopores for sequencing, chemical or protein sensing and disease diagnosis 28. Phage Portal Channels as Nanopore Sensors. 29. Controlled Co-assembly of Viral Nanoparticles of Simian Virus 40 with Inorganic Nanoparticles: Strategies and Applications 30. Potential of 3Dpol As An Enzymatic Reader for Direct RNA Sequencing. 31. Channel from bacterial virus T7 DNA packaging motor for the differentiation of peptides composed of a mixture of acidic and basic amino acids. 32. Nano-channel of viral DNA packaging motor as single pore to differentiate peptides with single amino acid difference.

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Book SynopsisPearl millet is mainly used for animal and poultry feed. It is the principal source of energy, protein, vitamins, minerals and contains many phenolic compounds, which are a good source of natural antioxidants. Pearl millet is a rich source of bioactive compounds and contains phytates and polyphenols. Owing to high nutritional and phytochemical properties, it has gained considerable attention as a botanical dietary supplement in many functional foods. Pearl Millet: Properties, Functionality and Its Applications provides comprehensive knowledge on nutritional and non-nutritional aspects of pearl millet. It covers recent research on pearl millet and provides information to improve the property and shelf life of flour, as well as the starch, and their uses in various food products.Features: Reviews structure, functional and antioxidant properties in pearl millet flour Deals with the latest developments in modiTable of ContentsChapter 1 Pearl Millet: A Drought Arrested Crop Chapter 2 Shelf Life Enhancement of Pearl Millet Flour Chapter 3 Phytochemicals and Antioxidant Properties in Pearl Millet: A Cereal Grain with Potential Applications Chapter 4 Effects of Different Milling Processes on Pearl Millet Chapter 5 Starch: Structure, Properties and Applications Chapter 6 Impact of Different Modifications on Starch Properties Chapter 7 Biotechnological Applications for Improvement of the Pearl Millet Crop Chapter 8 Biofortification and Medicinal Value of Pearl Millet Flour Chapter 9 Product Formulations

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Book SynopsisNanomaterials have supported humankindâs advancement, becoming one of the most important industry sectors, and are expected to rise to the top by 2030. However, significant challenges must be overcome, such as the performance and efficiency of the material under different environmental conditions. This book seeks to promote a critical view on using nanomaterials under extreme conditions found in our body, planet, and outer space. Therefore, nanomaterials are covered from multiple points of view, allowing the reader to get an enriching presentation of current knowledge on nanomaterials, limitations, advancements, and applications under extreme conditions.Table of ContentsNanomaterials under Extreme Conditions: Why Does It Matter? Nanomaterials: Physical and Chemical Properties. Characterization of Nanomaterials. Nanomaterials under High-temperature Conditions. Nanomaterials under Corrosive Conditions. Nanomaterials under Biological Conditions. Nanomaterials under Microgravity Conditions. Nanomaterials under High-Pressure Conditions. Future Perspectives: Nanomaterials, Industry, Legislations, and Dreams.

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Biomechanics applies the laws and techniques of mechanics in the study of biological systems and related phenomena. Biomechanics uses mathematical and computational tools such as model construction of musclo-skeletal system, body fluid circulation, to aid medical diagnosis, therapeutics and surgery planning, designing of prostheses and implants or in tissue engineering. Present book targets specific topics pertaining to the biomechanics of soft tissues. Subjects addressed includes solids and multi-species mixtures as open systems: a continuum mechanics perspective; electro-chemo-mechanical couplings: tissues with a fixed electric charge and growth of biological tissues.

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Book SynopsisThis edited book focuses on the role and use of VR for healthcare professions in both health and rehabilitation settings. It is also offers future trends of other emerging technology within medicine and allied health professions. This text draws on expertise of leading medical practitioners and researchers who utilise such VR technologies in their practices to enhance patient/service user outcomes. Research and practical evidence is presented with a strong applied emphasis to further enhance the use VR technologies within the community, the hospital and in education environment(s). The book may also be used to influence policymakers on how healthcare delivery is offered.Trade Review[Virtual Reality in Health and Rehabilitation ]… provides an overview of potential benefits in using virtual reality in rehabilitation. It highlights the emergence of virtual reality in recent years and how it has become more accessible. This book appears to be written for all practitioners and trainees to learn about virtual reality and its current applications. It overall meets this objective. The authors and contributors are a collection of professionals with diverse backgrounds associated with incorporating technology in medicine. As this is a young field, this book will help establish these individuals as content experts. Overall, this book is a nice introduction to the topic of virtual reality and medicine.Michael Nguyen, MD, MPH (Shirley Ryan AbilityLab)Table of ContentsSection 1: Introductory Perspective. 1. Introducing Virtual Reality for Health and Rehabilitation. Section 2: Virtual Reality in Neurological Rehabilitation. Chapter 2. On the Possibility of Using Virtual Reality to Improve the Mobility of People with Parkinson’s Disease. Chapter 3. Virtual Reality for Stroke Rehabilitation. Chapter 4. VR-based Assessment and intervention of Cognitive Functioning after Stroke. Chapter 5. Virtual Reality in Robotic Neurorehabilitation. Chapter 6. Virtual Reality Interventions’ Effects on Functional Outcomes for Children with Neurodevelopmental Disorders. Chapter 7: The use of Virtual Reality environments in Cognitive Rehabilitation after Traumatic Brain injury. Chapter 8: Effect of Virtual Reality-Based Training of the Ankle, Hip and Stepping Strategies on Balance after Stroke. Section 3: Virtual Reality for Health Education. Chapter 9: Simulation-Based Training for Ultrasound Practice. Chapter 10: Health Profession Education and Training using Virtual Reality. Section 4: Gamification and Virtual Reality in Contemporary Contexts. Chapter 11: Exergaming in multiple sclerosis – bridging the evidence-practice gap. Chapter 12: Participant adherence to a video game based tele-rehabilitation program – a mixed-methods case series. Chapter 13: Virtual Reality Game-based Exercises with Lead Motion Applied to Developmental Disorders. Section 5: Emerging Perspectives and Applications of Virtual Reality in Practice. Chapter 14: Applications of Virtual Reality in Aphasia Therapy: Findings from research with EVA Park. Chapter 15: Virtual Reality in Orthopedic Rehabilitation. Chapter 16: Emerging Perspectives of Virtual Reality Techniques. Chapter 17: Non-immersive Virtual Reality as a tool for treating children with cerebral palsy. Chapter 18: Virtual reality applications in the context of low vision rehabilitation. Chapter 19: Response of Woman with Mobility Impairments to a Group Weight Management Intervention in the Virtual World of SecondLife©

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Book SynopsisIncreasing population and industrialization are the key pollutant contributors in water bodies. The wastes generated by industries are highly hazardous for humans and the ecosystem and require a comprehensive and effective treatment before being discharged into water bodies. Over the years, many up gradations have been introduced in traditional water treatment methods which were expensive and ineffective especially for removal of toxic pollutants. Phycoremediation has been gaining attention due to its mutual benefit in wastewater treatment and for valuable algae biomass production. Wastewater, especially sewage and industrial effluents, is rich in pathogenic organisms, organic and inorganic compounds and heavy metals that adversely affect human and aquatic life. Microalgae use these inorganic compounds and heavy metals for their growth. In addition, they also reduce pathogenic organisms and release oxygen to be used by bacteria for decomposition of organic compounds in a secondary tTable of ContentsChapter 1: Addressing the Strategies of Algal Biomass Production with Wastewater TreatmentChapter 2: Recent progress of phytoremediation-based Technologies for industrial wastewater treatmentChapter 3: Microalgae as Biological cleanser for waste water treatmentChapter 4: Phycoremediation of Toxic Metals for Industrial Effluent TreatmentChapter 5: Algal Biomass Production Coupled to Wastewater TreatmentChapter 6: Photobioreactor in Waste Water Treatment: Design and Operational featuresChapter 7: Genetic Engineering of AlgaeChapter 8: Immobilized Micro Algae For Removing Waste Water Pollutants And Ecotoxicological View Of Adsorbed Nanoparticles – An OverviewChapter 9: Tailoring Microalgae for Efficient Biofuel Production

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Book SynopsisThe Synthetic Biology Handbook explains the major goals of the field of synthetic biology and presents the technical details of the latest advances made in achieving those goals. Offering a comprehensive overview of the current areas of focus in synthetic biology, this handbook: Explores the standardisation of classic molecular bioscience approaches Addresses the societal context and potential impacts of synthetic biology Discusses the use of legacy systems as tools for new product development Examines the design and construction of de novo cells and genetic codes Describes computational methods for designing genes and gene networks Thus, the Synthetic Biology Handbook provides an accurate sense of the scope of synthetic biology today. The handbook also affords readers with an opportunity to scrutinize the underlying scTable of ContentsSynthetic Biology: Culture and Bioethical Considerations. Synthetic Biology Standards and Methods of DNA Assembly. Standardised Genetic Output Measurement. Bacterial Cells as Engineered Chassis. Eukaryotae Synthetica: Synthetic Biology in Yeast, Microalgae, and Mammalian Cells. Synthetic Plants. Theory and Construction of Semi-Synthetic Minimal Cells. Design Tools for Synthetic Biology. New Genetic Codes.

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Book SynopsisFoundations of Confocal Scanned Imaging in Light Microscopy.- Fundamental Limits in Confocal Microscopy.- Special Optical Elements.- Points, Pixels, and Gray Levels: Digitizing Image Data.- Laser Sources for Confocal Microscopy.- Non-Laser Light Sources for Three-Dimensional Microscopy.- Objective Lenses for Confocal Microscopy.- The Contrast Formation in Optical Microscopy.- The Intermediate Optical System of Laser-Scanning Confocal Microscopes.- Disk-Scanning Confocal Microscopy.- Measuring the Real Point Spread Function of High Numerical Aperture Microscope Objective Lenses.- Photon Detectors for Confocal Microscopy.- Structured Illumination Methods.- Visualization Systems for Multi-Dimensional Microscopy Images.- Automated Three-Dimensional Image Analysis Methods for Confocal Microscopy.- Fluorophores for Confocal Microscopy: Photophysics and Photochemistry.- Practical Considerations in the Selection and Application of Fluorescent Probes.- Guiding Principles of Specimen PreservatioTable of ContentsFoundations of Confocal Scanned Imaging in Light Microscopy.- Fundamental Limits in Confocal Microscopy.- Special Optical Elements.- Points, Pixels, and Gray Levels: Digitizing Image Data.- Laser Sources for Confocal Microscopy.- Non-Laser Light Sources for Three-Dimensional Microscopy.- Objective Lenses for Confocal Microscopy.- The Contrast Formation in Optical Microscopy.- The Intermediate Optical System of Laser-Scanning Confocal Microscopes.- Disk-Scanning Confocal Microscopy.- Measuring the Real Point Spread Function of High Numerical Aperture Microscope Objective Lenses.- Photon Detectors for Confocal Microscopy.- Structured Illumination Methods.- Visualization Systems for Multi-Dimensional Microscopy Images.- Automated Three-Dimensional Image Analysis Methods for Confocal Microscopy.- Fluorophores for Confocal Microscopy: Photophysics and Photochemistry.- Practical Considerations in the Selection and Application of Fluorescent Probes.- Guiding Principles of Specimen Preservation for Confocal Fluorescence Microscopy.- Confocal Microscopy of Living Cells.- Aberrations in Confocal and Multi-Photon Fluorescence Microscopy Induced by Refractive Index Mismatch.- Interaction of Light with Botanical Specimens.- Signal-to-Noise Ratio in Confocal Microscopes.- Comparison of Widefield/Deconvolution and Confocal Microscopy for Three-Dimensional Imaging.- Blind Deconvolution.- Image Enhancement by Deconvolution.- Fiber-Optics in Scanning Optical Microscopy.- Fluorescence Lifetime Imaging in Scanning Microscopy.- Multi-Photon Molecular Excitation in Laser-Scanning Microscopy.- Multifocal Multi-Photon Microscopy.- 4Pi Microscopy.- Nanoscale Resolution with Focused Light: Stimulated Emission Depletion and Other Reversible Saturable Optical Fluorescence Transitions Microscopy Concepts.- Mass Storage, Display, and Hard Copy.- Coherent Anti-Stokes Raman Scattering Microscopy.- Related Methods for Three-Dimensional Imaging.- Tutorial on Practical Confocal Microscopy and Use of the Confocal Test Specimen.- Practical Confocal Microscopy.- Selective Plane Illumination Microscopy.- Cell Damage During Multi-Photon Microscopy.- Photobleaching.- Nonlinear (Harmonic Generation) Optical Microscopy.- Imaging Brain Slices.- Fluorescent Ion Measurement.- Confocal and Multi-Photon Imaging of Living Embryos.- Imaging Plant Cells.- Practical Fluorescence Resonance Energy Transfer or Molecular Nanobioscopy of Living Cells.- Automated Confocal Imaging and High-Content Screening for Cytomics.- Automated Interpretation of Subcellular Location Patterns from Three-Dimensional Confocal Microscopy.- Display and Presentation Software.- When Light Microscope Resolution Is Not Enough:Correlational Light Microscopy and Electron Microscopy.- Databases for Two- and Three-Dimensional Microscopical Images in Biology.- Confocal Microscopy of Biofilms — Spatiotemporal Approaches.- Bibliography of Confocal Microscopy.

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Book SynopsisGenetic Engineering: A Primer presents the growing field of biotechnology to non-science majors and other general interest readers. The author examines the natural forces that change genetic information and the ways in which scientists have learned to engineer these genetic changes. With a wealth of information flooding the popular press, including news and controversy surrounding cloning, Genetic Engineering is a timely volume that provides background information to the reader intent on understanding this fascinating development.Table of ContentsBuilding Blocks of Living Things. Matter and Living Things. Proteins. Nucleic Acid. How Living Things are Changed. Making and Altering Proteins. Altering Genetic Material in Bacteria. Genetically Engineering Bacteria. Viruses. Making Genetic Changes in Plants and Animals. Placing New Genes in Mammalian Cells. Genetic Engineering of Plants. Embryo Transfers and Cloning of Animals. How Genetic Engineering Helps Us. Gene Therapy and Disease. Other Applications for Gene Therapy. Biotechnology, Safety, and the Future. Glossary. Appendix.

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Book SynopsisBIOS Instant Notes in Genetics, Fourth Edition, is the perfect text for undergraduates looking for a concise introduction to the subject, or a study guide to use before examinations. Each topic begins with a summary of essential factsâ'an ideal revision checklistâ'followed by a description of the subject that focuses on core information, with clear, simple diagrams that are easy for students to understand and recall in essays and exams.Table of ContentsA. Molecular Genetics B. Genome Organization C. Mechanisms of Inheritance D. Population Genetics and Evolution E. DNA Technology F. Human Genetics G. Applications of Genetics

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Book SynopsisPharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals.Table of ContentsPreface. Acronyms. 1 Pharmaceuticals, biologics and biopharmaceuticals. 1.1 Introduction to pharmaceutical products. 1.2 Biopharmaceuticals and pharmaceutical biotechnology. 1.3 History of the pharmaceutical industry. 1.4 The age of biopharmaceuticals. 1.5 Biopharmaceuticals: current status and future prospects. 2 Protein structure. 2.1 Introduction. 2.2 Overview of protein structure. 2.3 Higher level structure. 2.4 Protein stability and folding. 2.5 Protein post-translational modifi cation. 3 Gene manipulation and recombinant DNA technology. 3.1 Introduction. 3.2 Nucleic acids: function and structure. 3.3 Recombinant production of therapeutic proteins. 3.4 Classical gene cloning and identifi cation. 4 The drug development process. 4.1 Introduction. 4.2 Discovery of biopharmaceuticals. 4.3 The impact of genomics and related technologies upon drug discovery. 4.4 Gene chips. 4.5 Proteomics. 4.6 Structural genomics. 4.7 Pharmacogenetics. 4.8 Initial product characterization. 4.9 Patenting. 4.10 Delivery of biopharmaceuticals. 4.10.3 Nasal, transmucosal and transdermal delivery systems. 4.11 Preclinical studies. 4.12 Pharmacokinetics and pharmacodynamics. 4.13 Toxicity studies. 4.14 The role and remit of regulatory authorities. 4.15 Conclusion. 5 Sources and upstream processing. 5.1 Introduction. 5.2 Sources of biopharmaceuticals. 5.3 Upstream processing. 6 Downstream processing. 6.1 Introduction. 6.2 Initial product recovery. 6.3 Cell disruption. 6.4 Removal of nucleic acid. 6.5 Initial product concentration. 6.6 Chromatographic purifi cation. 6.7 High-performance liquid chromatography of proteins. 6.8 Purifi cation of recombinant proteins. 6.9 Final product formulation. 7 Product analysis. 7.1 Introduction. 7.2 Protein-based contaminants. 7.3 Removal of altered forms of the protein of interest from the product stream. 7.4 Detection of protein-based product impurities. 7.5 Immunological approaches to detection of contaminants. 7.6 Endotoxin and other pyrogenic contaminants. 8 The cytokines: The interferon family. 8.1 Cytokines. 8.1.1 Cytokine receptors. 8.1.2 Cytokines as biopharmaceuticals. 8.2 The interferons. 8.3 Interferon biotechnology. 8.4 Conclusion. 9 Cytokines: Interleukins and tumour necrosis factor. 9.1 Introduction. 9.2 Interleukin-2. 9.3 Interleukin-1. 9.4 Interleukin-11. 9.5 Tumour necrosis factors. 10 Growth factors. 10.1 Introduction. 10.2 Haematopoietic growth factors. 10.3 Growth factors and wound healing. 11 Therapeutic hormones. 11.1 Introduction. 11.2 Insulin. 11.3 Glucagon. 11.4 Human growth hormone. 11.5 The gonadotrophins. 11.6 Medical and veterinary applications of gonadotrophins. 11.7 Additional recombinant hormones now approved. 11.8 Conclusion. 12 Recombinant blood products and therapeutic enzymes. 12.1 Introduction. 12.2 Haemostasis. 12.3 Anticoagulants. 12.4 Thrombolytic agents. 12.5 Enzymes of therapeutic value. 13 Antibodies, vaccines and adjuvants. 13.1 Introduction. 13.2 Traditional polyclonal antibody preparations. 13.3 Monoclonal antibodies. 13.4 Vaccine technology. 13.5 Adjuvant technology. 14 Nucleic-acid- and cell-based therapeutics. 14.1 Introduction. 14.2 Gene therapy. 14.3 Vectors used in gene therapy. 14.4 Gene therapy and genetic disease. 14.5 Gene therapy and cancer. 14.6 Gene therapy and AIDS. 14.7 Antisense technology. 14.8 Oligonucleotide pharmacokinetics and delivery. 14.9 Aptamers. 14.10 Cell- and tissue-based therapies. 14.11 Conclusion. Index.

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Book SynopsisThe biomaterials technology industry is already well established in the western world and is growing rapidly within Asian Pacific nations. It is often described as the 'next electronics industry', whilst the laser is described as a 'solution looking for a problem'.Table of ContentsAcknowledgements. Introduction. 1. Bioactivity and Biointegration of Orthopaedic and Dental Implants. 1.1. Introduction. 1.3. Biointegration of Orthopaedic and Dental Implants. 1.4. Controlling the Bone-Implant Interface. 2. Surface Modification of Biomaterials. 2.1. Introduction. 2.3. Metallic Implants. 2.4. Surface Modification of Biomaterials. 2.5. Laser Surface Modification of Biomaterials. 3. Wettability in Biomaterials Science and Modification Techniques. 3.1. Introduction. 3.2. Wettability, Adhesion and Bonding Theoretical Background. 3.3. Wettability in Biomaterial Science. 3.4. Current Methods of Wettability Modification. 3.5. Laser Wettability Characteristics Modification. 4. CO2 Laser Modification of the Wettability Characteristics of Magnesia Partially Stabilised Zirconia. 4.1. Introduction. 4.2. Experimental Procedures. 4.3. The Effects of CO2 Laser Radiation on Wettability Characteristics. 4.4. Surface Energy and its Component Parts. 4.5. Identification of the Predominant Mechanisms Active in Determining Wettability Characteristics. 4.6. The Role Played by Microstructures in Terms of Crystal Size and Phase in Effecting Surface Energy Changes. 4.7. Investigation of Wettability and Work Adhesion Using Physiological Liquids. 4.8. Summary. 5. In vitro Biocompatibility Evaluation of CO2 Laser Treated Magnesia Partially Stabilised Zirconia. 5.1. Introduction. 5.2. Sample Preparation. 5.3. Bone Like Apatite Formation. 5.4. Protein Adsorption. 5.5. Osteoblast Cell Response. 5.6. Predictions for Implantation in an in vivo Clinical Situation. 5.7. Summary. 6. The Effects of CO2 Laser Radiation on the Wettability Characteristics of a Titanium Alloy. 6.1. Introduction. 6.2. Experimental Procedures. 6.3. The Effects of CO2 Laser Radiation on Wettability Characteristics. 6.4. Surface Energy and its Component Analysis. 6.5. Identification of the Predominant Mechanisms Active in Determining Wettability Characteristics. 6.6. Investigation of Wettability and Work Adhesion Using Physiological Liquids. 6.7. Summary. 7. In vitro Biocompatibility Evaluation of CO2 Laser Treated Titanium Alloy. 7.1. Introduction. 7.2. Sample Preparation. 7.3. Bone Like Apatite Formation on Titanium Alloys. 7.4. Protein Adsorption. 7.5. Osteoblast Cell Adhesion. 7.6. Predictions for Implantation in an in vivo Clinical Situation. 7.7. Summary. 8. Enquiry into the Possible Generic Effects of the CO2 Laser Treatment on Bone Implant Biomaterials. 8.1. Introduction. 8.2. Ascertaining the Generic Effects of CO2 Laser Treatment on Bioinert Ceramics. 8.3. Ascertaining the Generic Effects of CO2 Laser Treatment on Metal Implants. 8.4. Summary. Conclusions. References. Index.

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Book SynopsisProviding an eclectic snapshot of the current state of the art and future implications of the field, Nanomaterials, Polymers, and Devices: Materials Functionalization and Device Fabrication presents topics grouped into three categorical focuses: The synthesis, mechanism and functionalization of nanomaterials, such as carbon nanotubes, graphene, silica, and quantum dots Various functional devices which properties and structures are tailored with emphasis on nanofabrication. Among discussed are light emitting diodes, nanophotonic, nano-optical, and photovoltaic devices Nanoelectronic devices, which include semiconductor, nanotube and nanowire-based electronics, single-walled carbon-nanotube based nanoelectronics, as well as thin-film transistors Table of ContentsCONTENTS Contributors vii Foreword xi 1 The Functionalization of Carbon Nanotubes and Nano-Onions 1Karthikeyan Gopalsamy, Zhen Xu, Chao Gao, and Eric S.-W. Kong 2 The Functionalization of Graphene and its Assembled Macrostructures 19Haiyan Sun, Zhen Xu, and Chao Gao 3 Devices Based on Graphene and Graphane 45Xiao-Dong Wen, Tao Yang, and Eric S.-W. Kong 4 Large-Area Graphene and Carbon Nanosheets for Organic Electronics: Synthesis and Growth Mechanism 81Han-Ik Joh, Sukang Bae, Sungho Lee, and Eric S.-W. Kong 5 Functionalization of Silica Nanoparticles for Corrosion Prevention of Underlying Metal 121Dylan J. Boday, Jason T. Wertz, and Joseph P. Kuczynski 6 New Nanoscale Material: Graphene Quantum Dots 141Dong-Ick Son and Won-Kook Choi 7 Recent Progress of Iridium(III) Red Phosphors for Phosphorescent Organic Light-Emitting Diodes 195Cheuk-Lam Ho and Wai-Yeung Wong 8 Four-Wave Mixing and Carrier Nonlinearities in Graphene–Silicon Photonic Crystal Cavities 215Tingyi Gu and Chee W. Wong 9 Polymer Photonic Devices 233Ziyang Zhang and Norbert Keil 10 Low Dielectric Contrast Photonic Crystals 273Jan H. Wülbern and Manfred Eich 11 Microring Resonator Arrays for Sensing Applications 291Daniel Pergande, Vanessa Zamora, Peter Lützow, and Helmut Heidrich 12 Polymers, Nanomaterials, and Organic Photovoltaic Devices 319Thomas Tromholt and Frederik C. Krebs 13 Next-Generation GaAs Photovoltaics 341Giacomo Mariani and Diana L. Huffaker 14 Nanocrystals, Layer-by-Layer Assembly, and Photovoltaic Devices 357Jacek J. Jasieniak, Brandon I. MacDonald, and Paul Mulvaney 15 Nanostructured Conductors for Flexible Electronics 395Jonghwa Park, Sehee Ahn, and Hyunhyub Ko 16 Graphene, Nanotube, and NW-Based Electronics 413Xi Liu, Xiaoling Shi, Lei Liao, Zhiyong Fan, and Johnny C. Ho 17 Nanoelectronics Based on Single-Walled Carbon Nanotubes 501Qing Cao and Shu-jen Han 18 Monolithic Graphene–Graphite Integrated Electronics 523Michael C. Wang, Jonghyun Choi, Jaehoon Bang, SungGyu Chun, Brandon Smith, and SungWoo Nam 19 Thin-Film Transistors Based on Transition Metal Dichalcogenides 539Woong Choi and Sunkook Kim Index 563

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Book SynopsisThis book gives an expert view of how the project management approach can be taken forward by the pharmaceutical industry over the next decade. The book integrates portfolio, program, and project management processes as fundamentals for effective and efficient drug product development.Table of ContentsPreface ix Acknowledgments xi About the Authors xiii Part One The Life Science Industry Context for Portfolio, Program, and Project Management 1. A Review of Project Management in Life Science Industry Sectors 3Thomas R. Dunson 2. The Impact of Organizational Size on Drug Project Management 21Eric Morfin 3. Drug Development in Biotechnology and How We Can Do It Better 33Susan Linna Part Two The Portfolio, Program, and Project Management Approaches and Processes 4. An Overview of the Organization and Processes of Portfolio, Program, and Project Management 53Pete Harpum 5. Portfolio Management in the Pharmaceutical Industry: Balancing Corporate Need with the Reality of Delivering Products to the Market 59John Bennett 6. Program Management in Drug Development 85Pauline Stewart-Long 7. Project Control 101Martin Powell 8. Managing Uncertainty in Drug Projects 135Pete Harpum and Thomas R. Dunson 9. Managing Drug Safety Risk 155Thomas R. Dunson and Eric Morfin 10. Developing Program Strategy 175Pete Harpum 11. Developing Products with “Added Value” 197Trevor J. Brown and Stephen Allport Part Three Integrating the Processes 12. Integrated Business Processes to Support Cross-Functional Drug Development 227Martin D. Hynes III 13. Integrated Drug Development: From Cradle to Grave and from Lab to Market 239Stephen Allport and Terry Cooke-Davies 14. The Development of P3M Capability in Drug Development Organizations 259John Arrowsmith, Patrick Grogan, and Bob Moore 15. Implementing Portfolio, Program, and Project Management Best Practices in Drug Development Organizations 287Pete Harpum, Ashley Jamieson, and Inge Fisher Bibliography 311 Index 313

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Book SynopsisA step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages.Table of ContentsPreface xi Acknowledgments xiii Contributors xv 1 Overview of Combination Products Development and Regulatory Review 1 Evan B. Siegel 2 Detailed Regulatory Approaches to Development, Review, and Approval 5 James Barquest 2.1 Introduction 5 2.2 General Background 6 2.2.1 Definitions 6 2.2.2 FDA Organization and Jurisdiction 7 2.2.3 Clinical Investigation and Premarket Review Requirements for Drugs, Biological Products, and Medical Devices 11 2.2.4 FDA Information Resources 15 2.3 Combination Products: Regulatory Background 16 2.3.1 Definition 16 2.3.2 Intercenter Agreements 18 2.3.3 Office of Combination Products 19 2.3.4 Primary Mode of Action 20 2.3.5 Intended Use 30 2.3.6 Strategic Regulatory Considerations 31 2.3.7 The Request for Designation (RFD) Process 34 2.3.8 User Fees 44 2.3.9 FDA Meetings: Successful Regulatory Interactions 50 2.3.10 Current Good Manufacturing Practice for Combination Products 59 2.4 Postmarketing Considerations 67 2.4.1 Adverse Event Reporting 68 2.4.1.1 Device Malfunction Reporting (21 CFR 803.3(r)(2)(ii), 21 CFR 803.20) 68 2.4.1.2 Five-Day MDR Reporting (21 CFR 803.10(c)(2)(i)) 68 2.4.1.3 Drug and Biological Product “Alert” Reporting (21 CFR 314.80(c)(1) and 600.80(c)(1)) 73 2.4.1.4 Blood-Related Deaths (21 CFR 606.170) 73 2.4.2 Other Compliance Issues 73 References 74 3 Nonclinical Recommendations for Successful Characterization and Development of Combination Drug Products 77 Duane B. Lakings 3.1 Introduction 77 3.2 Pharmacology 79 3.2.1 Pharmacology and Safety Pharmacology Recommendations for CDPs with Multiple Marketed Drugs 80 3.2.2 Pharmacology and Safety Pharmacology Recommendations for CDPs with Marketed Drugs and a Single NME 83 3.2.3 Pharmacology and Safety Pharmacology Recommendations for CDPs with More Than One NME 83 3.3 Pharmacokinetics 84 3.3.1 Pharmacokinetic and Drug Metabolism Recommendations for CDPs with Multiple Marketed Drugs 89 3.3.2 Pharmacokinetic and Drug Metabolism Recommendations for CDPs with Marketed Drugs and a Single NME 91 3.3.3 Pharmacokinetic and Drug Metabolism Recommendations for CDPs with More Than One NME 91 3.4 Toxicology 92 3.4.1 Toxicology Recommendations for CDPs with Multiple Marketed Drugs 98 3.4.2 Toxicology Recommendations for CDPs with Marketed Drugs and a Single NME 102 3.4.3 Toxicology Recommendations for CDPs with More Than One NME 104 3.5 Conclusions 108 References 109 4 Clinical Pharmacology and Clinical Development of Combination Products 113 Chaline Brown 4.1 Introduction 113 4.2 Postapproval Clinical Safety Reporting 115 4.3 Clinical Development of Drug–Delivery System Combination Products 116 4.3.1 Advantages of a New Delivery Device Drug Product 117 4.3.1.1 Streamlined Regulatory Process Possible 117 4.3.1.2 Improvement in Efficacy over Previously Approved Delivery Routes 117 4.3.1.3 Noninjection Bioavailability for Peptides and Proteins 118 4.3.2 Considerations for a Combination Product with a Novel Delivery Route 119 4.3.2.1 Impact of Infusion Pumps on Pharmacodynamic Effects 119 4.3.2.2 Route-Dependent Pharmaceutical Metabolic Profile 119 4.3.2.3 Inherent Delivery Site Sensitivity 119 4.3.2.4 Addressing Concerns Regarding the Safety of Excipients in Novel Routes of Delivery 120 4.3.2.5 Addressing Concerns of Possible Immune System Reactions During Development 120 4.3.2.6 Addressing Effects Specific to Human Physiology During Development 120 4.3.2.7 Addressing Formulation Changes During Clinical Development 121 4.3.3 Case Study: Exubera® (Pfizer’s inhaled insulin, approved January 2006) 121 4.4 Clinical Development of Drug–Active Device Combination Products 127 4.4.1 Case Study: The Drug-Eluting Stent (DES) 128 4.4.2 Changing Scene for New DES Products 132 4.5 Clinical Development of Co-Packaged Combination Products 134 4.5.1 Co-Packaged Drug and Biologic Case Study: Interferon and Ribavirin for the Treatment of Hepatitis C 135 4.6 Clinical Development of Drug–In Vitro Diagnostic Combination Products 140 4.6.1 Retrospective Changes in Drug Labeling to Incorporate Genetic Tests 143 4.6.2 Prospective Co-Development of Drugs and In Vitro Diagnostics 144 4.6.3 Issues Surrounding Biomarker Development 146 4.6.4 Clinical Trial Design Issues in Drug–In Vitro Diagnostic Co-Development 147 4.6.5 FDA Guidance 149 4.6.6 Case Study: Herceptin® and HercepTest® 150 4.7 Clinical Development of Drug–Biologic Combination Products 153 4.7.1 Case Study 1: Mylotarg® (Monoclonal Antibody Linked to a Cytotoxic Drug) 154 4.7.2 Case Study 2: Bexxar® (Monoclonal Antibody Linked to a Radioisotope) 157 4.8 Clinical Development of Drug–Drug Combinations 160 4.8.1 General Considerations for FDC Efficacy Studies 162 4.8.2 Case Study: CombinatoRx, with Combination Therapy as a Business Model 163 4.9 Conclusion 165 References 165 5 Regulatory Strategy Considerations for Chemistry, Manufacturing, and Controls: An Integrated Approach 171 Patrick L. DeVillier 5.1 Introduction 171 5.2 Office of Combination Products (OCP) and Request for Designation (RFD) 172 5.3 Extent of Regulatory Oversight 173 5.4 Investigational Device Exemption and Investigational New Drug Exemption 174 5.5 Regulatory Compliant Product Development 175 5.6 Chemistry, Manufacturing, and Controls Review Requirements 177 5.7 Drug Component Requirements 178 5.8 Device Component Requirements 179 5.9 Sterilization Considerations 179 5.10 Stability Considerations 180 5.11 Bench Testing and Early Development Considerations 180 5.12 CDP Regulatory Cross-Mapping Guidance and Recommendations 181 5.13 Conclusions 200 References 200 List of Abbreviations 201 Index 205

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