Global Approach in Safety Testing
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Description for Global Approach in Safety Testing
Hardcover. 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". Editor(s): Van der Laan, Jan Willem; DeGeorge, Joseph J. Series: AAPS Advances in the Pharmaceutical Sciences Series. Num Pages: 315 pages, 3 black & white illustrations, 13 colour illustrations, 23 black & white tables, biograph. BIC Classification: MBGR; TDCW. Category: (P) Professional & Vocational. Dimension: 241 x 160 x 23. Weight in Grams: 618.
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 ... Read more
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 ... Read more
Product Details
Format
Hardback
Publication date
2013
Publisher
Springer-Verlag New York Inc. United States
Number of pages
274
Condition
New
Series
AAPS Advances in the Pharmaceutical Sciences Series
Number of Pages
315
Place of Publication
New York, NY, United States
ISBN
9781461459491
SKU
V9781461459491
Shipping Time
Usually ships in 15 to 20 working days
Ref
99-15
About N/A
Dr. Jan Willem van der Laan was from 1990-2007 heading the Section Pharmacology and Toxicology Assessment at the National Institute for Public Health and the Environment (RIVM, Bilthoven). In this function he was responsible for the advice on non-clinical safety aspects for the Netherlands ‘College’, the Medicines Evaluation Board. Since September 2007 he is still senior assessor in pharmacology and ... Read more
Reviews for Global Approach in Safety Testing
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 ... Read more