{"product_id":"drug-development-strategies-and-routes-to-firstinhuman-trials-9780470170861","title":"Drug Development Strategies and Routes to","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eThe focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies.  Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\"As such, it may serve both as an introduction for newcomers but also as a reference for the more experienced ... The reader will find valuable advice on how to find the best strategy towards entry into the clinic.\" (ChemMedChem, 2011)\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003eContributors.  \u003cp\u003eForeward.\u003c\/p\u003e \u003cp\u003ePreface.\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART I INTRODUCTION.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Drug Discovery and Early Drug Development\u003c\/b\u003e (\u003ci\u003eMitchell N. Cayen\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e1.1 The Drug Discovery and Development Scene.\u003c\/p\u003e \u003cp\u003e1.2 Drug Discovery.\u003c\/p\u003e \u003cp\u003e1.3 Pre-FIH Drug Development.\u003c\/p\u003e \u003cp\u003e1.4 The FIH Trial.\u003c\/p\u003e \u003cp\u003e1.5 The Regulatory Landscape.\u003c\/p\u003e \u003cp\u003e1.6 Contract Research Organizations.\u003c\/p\u003e \u003cp\u003e1.7 Concluding Remairs to Introductory Perspectives.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART II LEAD OPTIMIZATION STRATEGIES.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 ADME Strategies in Lead Optimization\u003c\/b\u003e (\u003ci\u003eAmin A. Nomeir\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e2.1 Introduction.\u003c\/p\u003e \u003cp\u003e2.2 Absorption.\u003c\/p\u003e \u003cp\u003e2.3 Distribution.\u003c\/p\u003e \u003cp\u003e2.4 Metabolism.\u003c\/p\u003e \u003cp\u003e2.5 Excretion.\u003c\/p\u003e \u003cp\u003e2.6 Pharmacokinetics.\u003c\/p\u003e \u003cp\u003e2.7 Prioritizing ADME Screens.\u003c\/p\u003e \u003cp\u003e2.8 In Silico ADME Screening.\u003c\/p\u003e \u003cp\u003e2.9 The Promise of Metabolomics.\u003c\/p\u003e \u003cp\u003e2.10 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Prediction of Pharmacokinetics and Drug Safety in Humans\u003c\/b\u003e (\u003ci\u003ePeter L. Bullock\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e3.1 Introduction.\u003c\/p\u003e \u003cp\u003e3.2 Prediction of Human Pharmacokinetic Behavior.\u003c\/p\u003e \u003cp\u003e3.3 Prediction of Drug Safety.\u003c\/p\u003e \u003cp\u003e3.4 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Bioanalytical Strategies\u003c\/b\u003e (\u003ci\u003eChristopher Kemper\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e4.1 Introduction.\u003c\/p\u003e \u003cp\u003e4.2 Basic Bioanalytical Techniques and Method Development.\u003c\/p\u003e \u003cp\u003e4.3 Bioanalytical Method Validation.\u003c\/p\u003e \u003cp\u003e4.4  Special Issues with Ligand-Binding Assays.\u003c\/p\u003e \u003cp\u003e4.5 Partial and Cross-Validations.\u003c\/p\u003e \u003cp\u003e4.6 Application of Validated Methods to Sample Analyses: Some Perspectives.\u003c\/p\u003e \u003cp\u003e4.7 Risk-Based Paradigms: Discovery and Development Support.\u003c\/p\u003e \u003cp\u003e4.8 Road to \"First in Human\".\u003c\/p\u003e \u003cp\u003e4.9 International Perspectives.\u003c\/p\u003e \u003cp\u003e4.10 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART III BRIDGING FROM DISCOVERY TO DEVELOPMENT.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Chemistry, Manufacturing and Controls: The Drug Substance and Formulated Drug Product\u003c\/b\u003e (\u003ci\u003eÖrn Almarsson and Christopher J. Galli\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e5.1 Introduction.\u003c\/p\u003e \u003cp\u003e5.2 Pre-NCE Activities and CMC Development.\u003c\/p\u003e \u003cp\u003e5.3 CMC Consideration at the NCE Stage.\u003c\/p\u003e \u003cp\u003e5.4 NCE-to-GLP Transition (Bridging from Discovery to Pre-FIH Development).\u003c\/p\u003e \u003cp\u003e5.5 CMCs to Meet Clinical Trial Material Requirements.\u003c\/p\u003e \u003cp\u003e5.6 CMC Strategic Considerations.\u003c\/p\u003e \u003cp\u003e5.7 Case Studies.\u003c\/p\u003e \u003cp\u003e5.8 Evolution of Drug Development: Implications for CMCs in the Future.\u003c\/p\u003e \u003cp\u003eResources.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Nonclinical Safety Pharmacology Studies Recommended for Support of First-in-Human Clinical Trials\u003c\/b\u003e (\u003ci\u003eDuane B. Lakings\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e6.1 Introduction and Overview.\u003c\/p\u003e \u003cp\u003e6.2 Timing of Safety Pharmacology Studies.\u003c\/p\u003e \u003cp\u003e6.3 CNS Safety Pharmacology.\u003c\/p\u003e \u003cp\u003e6.4 Cardiovascular Safety Pharmacology.\u003c\/p\u003e \u003cp\u003e6.5 Respiratory System Safety Pharmacology.\u003c\/p\u003e \u003cp\u003e6.6 Renal\/Urinary Safety Pharmacology.\u003c\/p\u003e \u003cp\u003e6.7 Gastrointestinal System Safety Pharmacology.\u003c\/p\u003e \u003cp\u003e6.8 Autonomic Nervous System Safety Pharmacology.\u003c\/p\u003e \u003cp\u003e6.9 Other Systems.\u003c\/p\u003e \u003cp\u003e6.10 Discussion and Conclusion.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART IV PRE-IND DRUG DEVELOPMENT.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Toxicology Program to Support Initiation of a Clinical Phase I Program for a New Medicine\u003c\/b\u003e (\u003ci\u003eHugh E. Black, Stephen B. Montgomery and Ronald W. Moch\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e7.1 Introduction.\u003c\/p\u003e \u003cp\u003e7.2 Toxicology Support of Discovery.\u003c\/p\u003e \u003cp\u003e7.3 Goals of the Pre-FIH Toxicology Program.\u003c\/p\u003e \u003cp\u003e7.4 Importance of a Clinical Review of the Nonclinical Pharmacology Data.\u003c\/p\u003e \u003cp\u003e7.5 Take the Time to Plan Appropriately.\u003c\/p\u003e \u003cp\u003e7.6 The Active Pharmaceutical Ingredient.\u003c\/p\u003e \u003cp\u003e7.7 Timely Conduct of In Vitro Assays.\u003c\/p\u003e \u003cp\u003e7.8 Development of Validated Bioanalytical and Analytical Assays.\u003c\/p\u003e \u003cp\u003e7.9 Planning for the Conduct of Toxicity Studies.\u003c\/p\u003e \u003cp\u003e7.10 GLP Toxicology Program. \u003c\/p\u003e \u003cp\u003e7.11 Pre-IND Meeting.\u003c\/p\u003e \u003cp\u003e7.12 Conclusion.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Toxicokinetics in Support of Drug Development\u003c\/b\u003e (\u003ci\u003eGary Eichenbaum, Vangala Subrahmanyam and Alfred P.Tonelli\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e8.1 Introduction.\u003c\/p\u003e \u003cp\u003e8.2 Historical Perspectives.\u003c\/p\u003e \u003cp\u003e8.3 Regulatory Considerations.\u003c\/p\u003e \u003cp\u003e8.4 Factors to Consider in the Design of Toxicokinetic Studies.\u003c\/p\u003e \u003cp\u003e8.5 Toxicokinetic Parameter Estimates and Calculations.\u003c\/p\u003e \u003cp\u003e8.6 Interpretation of Toxicokinetic Data.\u003c\/p\u003e \u003cp\u003e8.7 Role of Toxicokinetics in Different Types of Toxicity Studies.\u003c\/p\u003e \u003cp\u003e8.8 Role of Toxicokinetics in Integrated Safety Assessment.\u003c\/p\u003e \u003cp\u003e8.9 Conclusion.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Good Laboratory Practices\u003c\/b\u003e (\u003ci\u003eAnthony B. Jones, Kathryn Hackett-Fields and Shari L. Perlstein\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e9.1 Introduction.\u003c\/p\u003e \u003cp\u003e9.2 Hazard and Risk.\u003c\/p\u003e \u003cp\u003e9.3 US GLP Regulations.\u003c\/p\u003e \u003cp\u003e9.4 GLPs in the Bioanalytical Laboratory.\u003c\/p\u003e \u003cp\u003e9.5 Moving Into the Future: A Closing Overview.\u003c\/p\u003e \u003cp\u003e9.6 Appendixes.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART V PLANNING THE FIRST-IN-HUMAN STUDY AND REGULATORY SUBMISSION.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Estimation of Human Starting Dose for Phase I Clinical Programs\u003c\/b\u003e (\u003ci\u003eLorrene A. Buckley, Parag Garhyan, Rafael Ponce and Stanley A. Roberts\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e10.1 Introduction.\u003c\/p\u003e \u003cp\u003e10.2 Characteristics of Well-Behaved Therapeutic Candidates.\u003c\/p\u003e \u003cp\u003e10.3 Regulatory Guidances for FIH-Enabling Preclinical Safety Assessment: General Principles.\u003c\/p\u003e \u003cp\u003e10.4 Nonclinical Pharmacokinetics and Pharmacodynamics for Human Dose Projection.\u003c\/p\u003e \u003cp\u003e10.5 Establishing the First-in-Human Dose.\u003c\/p\u003e \u003cp\u003e10.6 Phase I Clinical Trial Support: Use of MABEL or Pharmacologically Active Dose.\u003c\/p\u003e \u003cp\u003e10.7 Support of Exploratory Clinical Studies.\u003c\/p\u003e \u003cp\u003e10.8 Considerations in the Design of Phase I Trials.\u003c\/p\u003e \u003cp\u003e10.9 Interdisciplinary Partnerships.\u003c\/p\u003e \u003cp\u003e10.10 Beyond the FIH Dose.\u003c\/p\u003e \u003cp\u003e10.11 Concluding Perspective.\u003c\/p\u003e \u003cp\u003e10.12 Four Case Studies.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Exploratory INDs\/CTAs\u003c\/b\u003e (\u003ci\u003eMitchell N. Cayen\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e11.1 Introduction.\u003c\/p\u003e \u003cp\u003e11.2 Regulatory Background.\u003c\/p\u003e \u003cp\u003e11.3 Experience and Various Perspectives on ExpINDs or ExpCTAs.\u003c\/p\u003e \u003cp\u003e11.4 Some Reactions and Perspectives on the ExpIND\/ExpCTA Initiative.\u003c\/p\u003e \u003cp\u003e11.5 What Is an Ideal Candidate for an ExpIND\/ExpCTA?\u003c\/p\u003e \u003cp\u003e11.6 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Unique Considerations for Biopharmaceutics\u003c\/b\u003e (\u003ci\u003eLaura P. Andrews and James D. Green\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e12.1 Introduction and Background.\u003c\/p\u003e \u003cp\u003e12.2 Selection of the Molecule: Contrasts to Small-Molecule Considerations.\u003c\/p\u003e \u003cp\u003e12.3 Production and Process Considerations in Pre-FIH Development.\u003c\/p\u003e \u003cp\u003e12.4 Bioanalytical Assay Considerations.\u003c\/p\u003e \u003cp\u003e12.5 Objectives and Implementation of Pre-FIH Safety Assessment Programs.\u003c\/p\u003e \u003cp\u003e12.6 Post-IND Considerations: Support of Phase II and III and Registration.\u003c\/p\u003e \u003cp\u003e12.7 The TeGenero Incident and Implications for Biopharmaceutic Nonclinical Safety Evaluation Programs.\u003c\/p\u003e \u003cp\u003e12.8 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Project Management and International Regulatory Requirements for First-in-Human Trials\u003c\/b\u003e (\u003ci\u003eCarolyn D. Finkle and Judith Atkins\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e13.1 Introduction: Initiate Product Development with the End in Mind.\u003c\/p\u003e \u003cp\u003e13.2 Importance of Project Management.\u003c\/p\u003e \u003cp\u003e13.3 FDA Input Early and Often.\u003c\/p\u003e \u003cp\u003e13.4 IND Submission in the United States.\u003c\/p\u003e \u003cp\u003e13.5 Global Clinical Trials.\u003c\/p\u003e \u003cp\u003e13.6 Clinical Trial Application.\u003c\/p\u003e \u003cp\u003e13.7 Conclusion.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 First-in-Human Regulatory Submissions\u003c\/b\u003e (\u003ci\u003eMary Sommer, Mark Ammann, Ulf B. Hillgren, Kathleen J. Kovacs and Keith Wilner\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e14.1 Introduction.\u003c\/p\u003e \u003cp\u003e14.2 Submission Strategies.\u003c\/p\u003e \u003cp\u003e14.3 First-in-Human Dossiers.\u003c\/p\u003e \u003cp\u003e14.4 United States: Investigational New Drug Application.\u003c\/p\u003e \u003cp\u003e14.5 European Union: Clinical Trial Application.\u003c\/p\u003e \u003cp\u003e14.6 Japan: Clinical Trial Protocol Notification.\u003c\/p\u003e \u003cp\u003e14.7 Emerging Regions.\u003c\/p\u003e \u003cp\u003e14.8 Biopharmaceuticals.\u003c\/p\u003e \u003cp\u003e14.9 Final Considerations.\u003c\/p\u003e \u003cp\u003eAppendix 1: Abbreviations and Acronyms.\u003c\/p\u003e \u003cp\u003eAppendix 2: Definitions and Glossary of Terms.\u003c\/p\u003e \u003cp\u003eAppendix 3: Some Relevant Government and Regulatory Documents.\u003c\/p\u003e \u003cp\u003eAppendix 4: Some Relevant Resources with Web Sites.\u003c\/p\u003e \u003cp\u003eIndex. \u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49402298171735,"sku":"9780470170861","price":135.85,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780470170861.jpg?v=1730479986","url":"https:\/\/bookcurl.com\/products\/drug-development-strategies-and-routes-to-firstinhuman-trials-9780470170861","provider":"Book Curl","version":"1.0","type":"link"}