Overview
- Written by experts who were involved in the ICH process
- Provides state-of-the-art guidance
- Guidelines serve as teaching tools
Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series (AAPS, volume 5)
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Table of contents (14 chapters)
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Front Matter
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Back Matter
Keywords
About this book
Reviews
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 Society, Issue 43, Winter, 2013)Editors and Affiliations
About the editors
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 toxicology. He was from 2002-2010 project leader of the Teratology Information Service at the Institute. He moved in 2012 to the Medicines Evaluation Board located in Utrecht, but his role as senior assessor has not been changed. On behalf of this Board he is a member and vice-chair of the Safety Working Party (SWP) of the CHMP. His contributions to the International Conference on Harmonization started in early 1992 when he became a member of the Expert Working Group on Carcinogenicity Testing. Later on he became EU rapporteur for another topic in the Safety area, i.e. Immunotoxicology. In 2011 he finished as the EU rapporteur the Addendum for the Preclinical testing of Biotechnology-derived Proteins (ICH S6). In 2012 he is again involved in the new start of a topic on Carcinogenicity.
Joseph J. DeGeorge has a Ph.D. in Pharmacology from SUNY, Upstate Medical Center, Syracuse, NY, was a Postdoctoral Fellow at UNC, Chapel Hill, NC, and Burroughs-Wellcome Research Institute, and was a Senior Staff Fellow at the NIH/NIA in the Laboratory of Neuroscience. He has been actively engaged in the Safety and Multidisciplinary topics of the ICH as an Expert, Topic Rapporteur, and Safety Lead on numerous topics since the early 1990s. He is still actively engaged in ICH as of 2012. He has served these roles originally as a Food and Drug Administration representative and, following a brief hiatus, returned to the ICH as a PhRMA representative. He began his participation in the ICH process while serving as a Pharmacology and Toxicology reviewer inthe Neuropharmacology Division, CDER, FDA and took on increasing responsibility as his career progressed, culminating in the role of FDA ICH Safety Lead and Associate Director for Pharmacology and Toxicology for the Office of New Drugs, CDER/FDA. He joined the pharmaceutical industry in 2002, and has been Vice President of Global Safety Assessment at Merck &Co. since 2004. He also serves as the PhRMA Lead for ICH Safety topics, participating in the development of numerous new and revised ICH Safety Guidance's with a goal of enabling the safe and efficient development of new medicinal products.
Bibliographic Information
Book Title: Global Approach in Safety Testing
Book Subtitle: ICH Guidelines Explained
Editors: Jan Willem van der Laan, Joseph J. DeGeorge
Series Title: AAPS Advances in the Pharmaceutical Sciences Series
DOI: https://doi.org/10.1007/978-1-4614-5950-7
Publisher: Springer New York, NY
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: American Association of Pharmaceutical Scientists 2013
Hardcover ISBN: 978-1-4614-5949-1Published: 08 February 2013
Softcover ISBN: 978-1-4899-9407-3Published: 06 March 2015
eBook ISBN: 978-1-4614-5950-7Published: 11 February 2013
Series ISSN: 2210-7371
Series E-ISSN: 2210-738X
Edition Number: 1
Number of Pages: XII, 315
Number of Illustrations: 3 b/w illustrations, 13 illustrations in colour
Topics: Pharmaceutical Sciences/Technology, Biomedicine general