Global Approach in Safety Testing

This volume considers topics relating to saftey in in vitro and in vivo pre-clinical studies. Exploring and analyzing ICH Guidance documents, the comprehensive text includes discussions of “lessons learnt” and “future developments”.

This volume will consider one of ICH’s major categories, Safetyi.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”.

The  International Conference on Harmonisation. History of Safety Guidelines.- EU Perspective on ICH.- The Value and Benefits of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities Advancing Harmonization for Better Public Health.- A Japanese Perspective on Implementation of the Three Rs: Incorporating Best Scientific Practices into Regulatory Process.- Towards more Scientific Relevance in Carcinogenicity Testing.- The Evolution, Scientific Reasoning and Use of ICH S2 Guidelines for Genotoxicity Testing of Pharmaceuticals.- Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies , Where are we now; an  S3A/S3B update (1995-2011).- Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B).- Why and how did Reproduction Toxicity Testing make its early entry into and Rapid Success in ICH?.- ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.- Safety Pharmacology: Guidelines S7A and S7B.- ICH S8:  History and Perspectives.- ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals a Perspective from Regulators on the Development of the Guideline.- Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals ICH M3 and M3(R2).