{"product_id":"clinical-trials-handbook-pharmaceutical-development-series-8-9780471213888","title":"Clinical Trials Handbook Pharmaceutical","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eProvides a comprehensive and thorough reference on the basics and practices of clinical trials Includes chapters on hot topics like: adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs Presents chapters on issues for specific disease areas: cardiology, oncology, cognitive, dermatology, etc.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003ePreface.  \u003cp\u003e1 Introduction to Clinical Trials (John Goffin).\u003c\/p\u003e \u003cp\u003e2 Regulatory Requirements for Investigational New Drug (Venkat Rao).\u003c\/p\u003e \u003cp\u003e3 Preclinical Assessment of Safety in Human Subjects (Nancy Wintering and Andrew B. Newberg).\u003c\/p\u003e \u003cp\u003e4 Predicting human adverse drug reactions from non-clinical safety studies (Jean-Pierre Valentin, Marianne Keisu \u0026amp; Tim G. Hammond).\u003c\/p\u003e \u003cp\u003e5.1 History of Clinical Trial Development and the Pharmaceutical Industry (Jeffery Peppercorn and Thomas Roberts).\u003c\/p\u003e \u003cp\u003e5.2 Adaptive Research (Michael Rosenberg).\u003c\/p\u003e \u003cp\u003e6 Organization and Planning (Sheila Sprague and Mohit Bhandari).\u003c\/p\u003e \u003cp\u003e7 The Process of Data Management (Nina Trocky and Cynthia Barndt).\u003c\/p\u003e \u003cp\u003e8 Clinical Trials Data Management (Eugenio Santoro and Angelo Tinazzi).\u003c\/p\u003e \u003cp\u003e9.1 Clinical Trials and the FDA (Tarek M. Mahfouz and Janelle S. Crossgrove).\u003c\/p\u003e \u003cp\u003e9.2 Phase I Clinical Trials (Shayne Gad).\u003c\/p\u003e \u003cp\u003e9.3 Phase II Clinical Trials (Say-Beng Tan and David Machin).\u003c\/p\u003e \u003cp\u003e9.4 Designing and Conducting Phase III Studies (Nabil Saba, M.D., John Kauh, M.D., and Dong M. Shin, M.D.).\u003c\/p\u003e \u003cp\u003e9.5 Phase IV (Karl Wegscheider).\u003c\/p\u003e \u003cp\u003e9.6 Phase IV and Post Marketing Clinical Trials (Ali Miraj Khan).\u003c\/p\u003e \u003cp\u003e9.7 Regulatory Approval (Fred Henry and Weichung J. Shih).\u003c\/p\u003e \u003cp\u003e9.8 A New Paradigm for Analyzing Adverse Drug Events (Ana Szarfman, Jonathan G. Levine, and Joseph M. Tonning).\u003c\/p\u003e \u003cp\u003e10.1 Clinical Trials in Interventional Cardiology: Focus on the XIENCE Drug-Eluting Stent (Doostzadeh J, Bezenek S, Cheong W-F, Sood P, Schwartz L, Sudhir K).\u003c\/p\u003e \u003cp\u003e10.2 Clinical Trials Involving Oral Diseases (Bruce L Pihlstrom, Bryan Michalowicz, Jane Atkinson and Albert Kingman).\u003c\/p\u003e \u003cp\u003e10.3 Dermatology Clinical Trials (Maryanne Kazanis, Alicia Van Cott, Alexa Boer Kimball).\u003c\/p\u003e \u003cp\u003e10.4 Emergency Clinical Trials (Joaquin Borras-Blasco, Andres Navarro-Ruiz and Consuelo Borras).\u003c\/p\u003e \u003cp\u003e10.5 Gastroenterology (Lise Lotte Gluud and Jorgen Rask-Madsen).\u003c\/p\u003e \u003cp\u003e10.6 Gynaecology Randomised Control Trials (Khalid Khan).\u003c\/p\u003e \u003cp\u003e10.7 Special Population Studies (Healthy Patient Studies) (Doris K. Weilert).\u003c\/p\u003e \u003cp\u003e10.8 Musculoskeletal (Masami Akai).\u003c\/p\u003e \u003cp\u003e10.9 Oncology (Matjaz Zwitter).\u003c\/p\u003e \u003cp\u003e10.10 Pharmacological Treatment Options for Non-exudative and exudative age-related macular degeneration (Alejandro Oliver, Thomas Ciulla, and Alon Harris).\u003c\/p\u003e \u003cp\u003e10.11 Paediatrics (Anne Cusick, Natasha Lannin \u0026amp; Iona Novak).\u003c\/p\u003e \u003cp\u003e10.12 Dementia (Encarnita Raya-Ampil and Jeffrey Cummings).\u003c\/p\u003e \u003cp\u003e10.13 Clinical Trials in Urology (Geoffrey R Wignall, Carol Wernecke, Linda Nott \u0026amp; Hassan Razvi).\u003c\/p\u003e \u003cp\u003e10.14 Clinical Trials on Cognitive Drugs (Elisabetta Farina and Francesca Baglio).\u003c\/p\u003e \u003cp\u003e10.15 Bridging Studies in Pharmaceutical Safety Assessment (Jon Ruckle).\u003c\/p\u003e \u003cp\u003e10.16 A Brief History of Clinical Trials on Vaccines (Megan J. Brooks, Joseph J. Sasadeusz, and Gregory A. Tannock).\u003c\/p\u003e \u003cp\u003e11 Methods of Randomization (Gladys McPherson and Marion Campbell).\u003c\/p\u003e \u003cp\u003e12 Randomized Controlled Trials (Giuseppe Garcea and David P. Berry).\u003c\/p\u003e \u003cp\u003e13 Cross-Over Designs (Raphael Porcher and Sylvie Chevret).\u003c\/p\u003e \u003cp\u003e14.1 Biomarkers (Michael R. Bleavins, Claudio Carini, Malle Jurima-Romet, and Ramin Rahbari).\u003c\/p\u003e \u003cp\u003e14.2 Biomarkers in clinical drug development: parallel analysis of Alzheimer Disease and Multiple Sclerosis (Christine BETARD, Filippo MARTINELLI BONESCHI \u0026amp; Paulo CARAMELLI).\u003c\/p\u003e \u003cp\u003e15 Review Boards (Maureen Hood, Jason Kaar, and Vincent Ho).\u003c\/p\u003e \u003cp\u003e16 Size of Clinical Trials (Jitendra Ganju).\u003c\/p\u003e \u003cp\u003e17 Blinding and Placebo (Artur Bauhofer).\u003c\/p\u003e \u003cp\u003e18 Pharmacology (Thierry Buclin).\u003c\/p\u003e \u003cp\u003e19 Modeling and Simulation in Clinical Drug Development (Jerry Nedelman, Frank Bretz, Roland Fisch, Anna Georgieva, Chyi-Hung Hsu, Joseph Kahn, Ryosei Kawai, Phil Lowe, Jeff Maca, Jose’ Pinheiro, Anthony Rossini, Heinz Schmidli, Jean-Louis Steimer, Jing Yu).\u003c\/p\u003e \u003cp\u003e20 Monitoring (Nigel Stallard and Susan Todd).\u003c\/p\u003e \u003cp\u003e21 Inference Following a Sequential Clinical Trial (Aiyi Liu and Kai F. Yu).\u003c\/p\u003e \u003cp\u003e22 Statistical methods for Analysis of Clinical Trials (Duolao Wang, Ameet Bakhai, and Nicola Maffulli).\u003c\/p\u003e \u003cp\u003e23 Explanatory and Pragmatic Clinical Trials (Rob Herbert).\u003c\/p\u003e \u003cp\u003e24.1 Ethics of Clinical Research in Durg Trials (Roy G. Beran).\u003c\/p\u003e \u003cp\u003e24.2 Ethical Issues in Clinical Research (Kelton Tremellen and David Belford).\u003c\/p\u003e \u003cp\u003e25 Regulations (Ramzi Dagher, Rajeshwari Sridhara, Nallaperumal Chidambaram, and Brian P. Booth).\u003c\/p\u003e \u003cp\u003e26 Future Challenges in the Design and Ethics of Clinical Trials (Carl-Fredrik Burman and Axel Carlberg).\u003c\/p\u003e \u003cp\u003e27 Proof-of-Principle\/Proof-of-Concept trials in Drug Development (Ayman Al-Shurbaji).\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49402527973719,"sku":"9780471213888","price":193.46,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780471213888.jpg?v=1730480674","url":"https:\/\/bookcurl.com\/products\/clinical-trials-handbook-pharmaceutical-development-series-8-9780471213888","provider":"Book Curl","version":"1.0","type":"link"}