Highlighting key points from the latest regulatory requirements, New Drug Development helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than 40 respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more.
"…the chapters are readable, the figures are clear in reproduction, the result being a useful text that I believe meets its goal of being an introductory text to drug development from a pharmacokinetic regulatory point-of-view."
"…a timely book which combines the scientific and regulatory aspects of clinical pharmacology and biopharmaceutics in easy-to-understand chapters that cover all aspects of drug development….fills an existing void and further provides a quick reference guide for the industrial or academic scientist who is new in the field."-
. Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, and Acting Deputy Commissioner for Operations, Food and Drug Administration