New Drug Development: Design, Methodology, and Analysis

Praise for New Drug Development "I highly recommend this text as a comprehensive and very readable presentation of the process and nuances of new drug development. It is a concise and practical book that is well suited for several groups [including] individuals working in pharmaceutical drug development, healthcare providers, and students aspiring to work in either profession." Anita Flick, MD, Health Professions Advising, North Carolina State University "Dr. Turner?s book provides a panoramic overview of the complex process of new drug development, integrating discussions of drug discovery, nonclinical research, pre–approval clinical trials, and post–marketing surveillance. Students and professionals entering the worlds of pharmaceutical clinical research and medical practice will benefit greatly from this book, which is now required reading in our company." Anton–Lewis Usala, MD, President and CEO, Clinical Trials Management Group, Inc. An indispensable and modern overview of the design concepts and statistical practices involved in therapeutic drug development From the initial stages of identifying a potential drug candidate to receiving FDA approval, New Drug Development focuses on the collection, analysis, and interpretation of numerical representations of information throughout the drug development process. This timely text provides a self–contained overview of the new drug development process, while also emphasizing the importance of ethical, biological, social, and political considerations. Using a relatively pragmatic approach, the author clearly illustrates how the discipline of statistics makes a central contribution to the complex process of new drug development, and these statistical issues are presented conceptually rather than computationally. This book features: A realistic, scientific, and progressive organization from pre–clinical studies to clinical research that is educationally powerful The discovery and development of new drugs using the latest advances in various fields, including molecular biology, computational chemistry and biology, computer–aided molecular design, proteomics, and bioinformatics The design, methodology, and analysis essential for the development of drugs that succeed in safely treating diseases and conditions of clinical concern New Drug Development is an essential guide for entry–level professionals in the pharmaceutical, biotechnology, and contract research organization (CRO) industries as well as seasoned clinical research professionals who wish to refresh their knowledge in areas outside their immediate fields of expertise.