New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients by Lawrence T. Friedhoff English | 2009 | ISBN: 141969961X | 258 pages | EPUB + MOBI | 0,6 + 1,1 MB
Quantitative Decisions in Drug Development By Christy Chuang-Stein English | PDF(Repost),EPUB | 2017 | 255 Pages | ISBN : 3319460757 | 4.24 MB
This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development.