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Global approach in safety testing : ICH guidelines explained

Author: Jan Willem van der Laan; Joseph J DeGeorge
Publisher: New York ; London : Springer, 2013.
Series: AAPS advances in the pharmaceutical sciences series, v. 5.
Edition/Format:   eBook : Document : EnglishView all editions and formats
Summary:
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the US and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. In Japan, the members are the Ministry of Health, Labour and  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Global approach in safety testing.
New York ; London : Springer, 2013
(OCoLC)816164723
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Jan Willem van der Laan; Joseph J DeGeorge
ISBN: 9781461459507 1461459508
OCLC Number: 828148388
Description: 1 online resource.
Contents: The International Conference on Harmonisation: History of Safety Guidelines / Jan Willem van der Laan, Joseph J. DeGeorge --
EU Perspective on ICH / Spiros Vamvakas --
The Value and Benefits of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health / Justina A. Molzon --
A Japanese Perspective on Implementation of the Three Rs: Incorporating Best Scientific Practices into Regulatory Process / Yasuo Ohno --
Toward More Scientific Relevance in Carcinogenicity Testing / Jan Willem van der Laan, Joseph J. DeGeorge --
The Evolution, Scientific Reasoning and Use of ICH S2 Guidelines for Genotoxicity Testing of Pharmaceuticals / Lutz Müller, David Tweats, Sheila Galloway --
Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies, Where Are We Now; An S3A/S3B Update (1995-2011) / Bruce Campbell, Bob Ings --
Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B) / Per Spindler, Herman Van Cauteren --
Why and How Did Reproduction Toxicity Testing Make Its Early Entry into and Rapid Success in ICH? / Rolf Bass, Yasuo Ohno, Beate Ulbrich --
ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals / Joy Cavagnaro, Jennifer Sims --
Safety Pharmacology: Guidelines S7A and S7B / John E. Koerner, Peter K.S. Siegl --
ICH S8: History and Perspectives / Kenneth L. Hastings --
ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals: A Perspective from Regulators on the Development of the Guideline / John K. Leighton, Klaus Olejniczak, Hiroshi Onodera --
Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals: ICH M3 and M3(R2) / Per Sjöberg, David R. Jones.
Series Title: AAPS advances in the pharmaceutical sciences series, v. 5.
Responsibility: edited by Jan Willem van der Laan, Joseph J. DeGeorge.

Abstract:

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  Read more...

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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 Read more...

 
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