From the reviews:
“This book is an excellent read and gives detail into all aspects of nonclinical testing needed to get new drugs into the clinic and beyond, as well as useful insight into the decisions behind the testing recommendations in the guidelines. Well done editors in putting all this together.” (Paul Baldrick, BTS Newsletter – The British Toxicology Society, Issue 43, Winter, 2013)Global Approach in Safety Testing
ICH Guidelines Explained
herausgegeben von Jan Willem van der Laan und Joseph J DeGeorgeThis volume will consider one of ICH’s major categories, Safety i. e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.
