Global Approach in Safety Testing

ICH Guidelines Explained

Editors:

ISBN: 978-1-4614-5949-1 (Print) 978-1-4614-5950-7 (Online)

Table of contents (14 chapters)

  1. Front Matter

    Pages i-xii

  2. No Access

    Book Chapter

    Pages 1-12

    The International Conference on Harmonisation: History of Safety Guidelines

  3. No Access

    Book Chapter

    Pages 13-21

    EU Perspective on ICH

  4. No Access

    Book Chapter

    Pages 23-27

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

  5. No Access

    Book Chapter

    Pages 29-35

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

  6. No Access

    Book Chapter

    Pages 37-75

    Toward More Scientific Relevance in Carcinogenicity Testing

  7. No Access

    Book Chapter

    Pages 77-118

    The Evolution, Scientific Reasoning and Use of ICH S2 Guidelines for Genotoxicity Testing of Pharmaceuticals

  8. No Access

    Book Chapter

    Pages 119-158

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

  9. No Access

    Book Chapter

    Pages 159-174

    Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B)

  10. No Access

    Book Chapter

    Pages 175-214

    Why and How Did Reproduction Toxicity Testing Make Its Early Entry into and Rapid Success in ICH?

  11. No Access

    Book Chapter

    Pages 215-242

    ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

  12. No Access

    Book Chapter

    Pages 243-265

    Safety Pharmacology: Guidelines S7A and S7B

  13. No Access

    Book Chapter

    Pages 267-281

    ICH S8: History and Perspectives

  14. No Access

    Book Chapter

    Pages 283-298

    ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals: A Perspective from Regulators on the Development of the Guideline

  15. No Access

    Book Chapter

    Pages 299-309

    Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals: ICH M3 and M3(R2)

  16. Back Matter

    Pages 311-315