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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| Other Authors: | , |
| Language: | English |
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New York, NY :
Springer New York : Imprint: Springer,
2013.
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| Edition: | 1st ed. 2013. |
| Series: | AAPS Advances in the Pharmaceutical Sciences Series,
5 |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/978-1-4614-5950-7 |
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).