J. Rick Turner

New Drug Development (eBook, PDF)

An Introduction to Clinical Trials: Second Edition

• Format: PDF

Produktbeschreibung

New Drug Development, 2nd Edition, is a reader-friendly introduction to clinical trials that is written specifically for entry-level professionals in the pharmaceutical, biopharmaceutical, and contract research organization (CRO) industries. It is also excellent reading for seasoned clinical research professionals who wish to refresh their knowledge in areas outside their immediate fields of expertise, and for students of clinical research, pharmacy, medicine, nursing, and allied health professions. While the main focus is on preapproval clinical trials, the book adopts a lifecycle drug development approach, placing these trials in the overall continuum from drug discovery to postmarketing surveillance. It therefore contains brief discussions of medicinal chemistry, nonclinical research, drug manufacturing, and the latest techniques for gathering information concerning adverse drug reactions. This edition builds on the success of the first edition by keeping the discussions that weremost helpful to readers, and adding new chapters addressing important contemporary topics in drug development. The chapters dealing with the design and analysis of clinical trials in the first edition received praise from many sources. This new edition incorporates extended discussions of the operational aspects of conducting various kinds of trials, ranging from highly specialized and relatively small cardiac safety studies to very large, multi-site Phase III trials run in several different countries.

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Produktdetails

• Verlag: Springer US
• Seitenzahl: 256
• Erscheinungstermin: 16. Juli 2010
• Englisch
• ISBN-13: 9781441964182
• Artikelnr.: 37345078

Autorenporträt

Dr. Rick Turner is an experimental research scientist, clinical trialist, and author. He was awarded his doctoral degree in the field of Cardiovascular Behavioral Medicine in 1984. His innovative genetic research in that discipline led to 50 peer-reviewed papers, five books, and two international research awards. Fifteen years ago Dr. Turner moved into the pharmaceutical industry, holding positions as a Clinical Submissions Scientist at GlaxoSmithKline and as President and Chief Scientific Officer at Turner Medical Communications LLC. He is now Senior Scientific Director, Cardiac Safety Services, at Quintiles, the world's largest pharmaceutical contract research organization. His work focuses on assessing the cardiac safety of non-cardiac drugs. He has spoken before two FDA Advisory Committees on cardiovascular safety issues, given numerous presentations at international conferences, and published several recent peer-reviewed papers in this field. He is also the senior author of 'Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance' (Turner and Durham, 2009).

Inhaltsangabe

New Drug Development.- The Regulatory Environment.- Drug Discovery.- Nonclinical Research.- Designing Clinical Trials.- Conducting Clinical Trials I: Experimental Methodology.- Conducting Clinical Trials II: Operational Execution.- Statistical Analysis.- Statistical Significance.- Clinical Significance.- Sample Size Estimation.- General Safety Assessments.- Efficacy Assessment.- Cardiac and Cardiovascular Safety Assessments.- Manufacturing Small Molecule Drugs and Biologicals.- Postmarketing Surveillance.- Main Themes and Concluding Comments.

Rezensionen

From the reviews of the second edition:

"'New Drug Development: An Introduction to Clinical Trials, 2^nd Edition' is a solid introduction to the process of drug development, with an emphasis on clinical research, especially the statistical aspects. It is ideal for readers interested in clinical research within the broader context. The book is written in a practical and straightforward manner ... ." (Norman M. Goldfarb, Journal of Clinical Research Best Practices, Vol. 9 (5), May, 2013)