Laan, Jan Willem van der

Global Approach in Safety Testing

Laan, Jan Willem van der - Global Approach in Safety Testing, ebook


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ISBN: 9781461459507
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Table of contents

1. The International Conference on Harmonisation: History of Safety Guidelines
Jan Willem Laan, Joseph J. DeGeorge

2. EU Perspective on ICH
Spiros Vamvakas

3. The Value and Benefits of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health
Justina A. Molzon

4. A Japanese Perspective on Implementation of the Three Rs: Incorporating Best Scientific Practices into Regulatory Process
Yasuo Ohno

5. Toward More Scientific Relevance in Carcinogenicity Testing
Jan Willem Laan, Joseph J. DeGeorge, Frank Sistare, Jonathan Moggs

6. The Evolution, Scientific Reasoning and Use of ICH S2 Guidelines for Genotoxicity Testing of Pharmaceuticals
Lutz Müller, David Tweats, Sheila Galloway, Makoto Hayashi

7. Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies, Where Are We Now; An S3A/S3B Update (1995–2011)
Bruce Campbell, Bob Ings

8. Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B)
Per Spindler, Herman Cauteren

9. Why and How Did Reproduction Toxicity Testing Make Its Early Entry into and Rapid Success in ICH?
Rolf Bass, Yasuo Ohno, Beate Ulbrich

10. ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
Joy Cavagnaro, Jennifer Sims

11. Safety Pharmacology: Guidelines S7A and S7B
John E. Koerner, Peter K. S. Siegl

12. ICH S8: History and Perspectives
Kenneth L. Hastings

13. ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals: A Perspective from Regulators on the Development of the Guideline
John K. Leighton, Klaus Olejniczak, Hiroshi Onodera

14. Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals: ICH M3 and M3(R2)
Per Sjöberg, David R. Jones

Keywords: Biomedicine, Pharmaceutical Sciences/Technology, Biomedicine general

Publication year
AAPS Advances in the Pharmaceutical Sciences Series
Page amount
12 pages
Medicine, Health Care, Mode

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