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Global Approach in Safety Testing ICH Guidelines Explained /

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...

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Bibliographic Details
Corporate Author: SpringerLink (Online service)
Other Authors: van der Laan, Jan Willem. (Editor, http://id.loc.gov/vocabulary/relators/edt), DeGeorge, Joseph J. (Editor, http://id.loc.gov/vocabulary/relators/edt)
Format: Electronic eBook
Language:English
Published: New York, NY : Springer New York : Imprint: Springer, 2013.
Edition:1st ed. 2013.
Series:AAPS Advances in the Pharmaceutical Sciences Series, 5
Subjects:
Pharmaceutical technology.
Medicine.
Pharmaceutical Sciences/Technology.
Biomedicine, general.
Online Access:https://doi.org/10.1007/978-1-4614-5950-7
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Table of Contents:
  • The  International Conference on Harmonisation. History of Safety Guidelines
  • EU Perspective on ICH
  • The Value and Benefits of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities Advancing Harmonization for Better Public Health
  • A Japanese Perspective on Implementation of the Three Rs: Incorporating Best Scientific Practices into Regulatory Process
  • Towards more Scientific Relevance in Carcinogenicity Testing
  • The Evolution, Scientific Reasoning and Use of ICH S2 Guidelines for Genotoxicity Testing of Pharmaceuticals
  • Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies , Where are we now; an  S3A/S3B update (1995-2011)
  • Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B)
  • Why and how did Reproduction Toxicity Testing make its early entry into and Rapid Success in ICH?
  • ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
  • Safety Pharmacology: Guidelines S7A and S7B
  • ICH S8:  History and Perspectives
  • ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals a Perspective from Regulators on the Development of the Guideline
  • Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals ICH M3 and M3(R2).

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