Global Approach in Safety Testing : ICH Guidelines Explained
2013 ed.
Book Details
Format
Hardback or Cased Book
ISBN-10
1461459494
ISBN-13
9781461459491
Edition
2013 ed.
Publisher
Springer-Verlag New York Inc.
Imprint
Springer-Verlag New York Inc.
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Feb 8th, 2013
Print length
315 Pages
Weight
618 grams
Dimensions
24.10 x 16.00 x 2.30 cms
Product Classification:
Medical researchPre-clinical medicine: basic sciencesChemistry
Ksh 23,400.00
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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.
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”.
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