Genotoxicity and Carcinogenicity Testing of Pharmaceuticals
This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further i...
| Other Authors: | , |
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| Format: | eBook |
| Language: | English |
| Published: |
Cham
Springer International Publishing
2015, 2015
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| Edition: | 1st ed. 2015 |
| Subjects: | |
| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of Contents:
- Introduction
- History and Current Regulatory Requirements
- Genotoxicity Testing of API and Impurities
- New Emerging Genotoxicity Tests
- Carcinogenicity Testing of Small Molecules
- Alternatives to the 2-Year Rodent Studies
- Addressing Positive Findings in Carcinogenicity Studies
- Investigating Tumor Signals in Clinical Trials
- Tumor Promoters
- Carcinogenicity Testing of Biologics
- In Silico Predictive Tests