Global Approach in Safety Testing - ICH Guidelines Explained (Paperback, 2013 ed.)

This 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".

General

Imprint:	Springer-Verlag New York
Country of origin:	United States
Series:	AAPS Advances in the Pharmaceutical Sciences Series, 5
Release date:	March 2015
First published:	2013
Editors:	Jan Willem van der Laan • Joseph J. DeGeorge
Dimensions:	235 x 155 x 18mm (L x W x T)
Format:	Paperback
Pages:	315
Edition:	2013 ed.
ISBN-13:	978-1-4899-9407-3
Categories:	Books > Medicine > General issues > Medical equipment & techniques > Medical research Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology Promotions
LSN:	1-4899-9407-6
Barcode:	9781489994073

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