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...
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| Otros Autores: | , |
| Formato: | Libro electrónico |
| Idioma: | Inglés |
| Publicado: |
Cham :
Springer International Publishing
2015.
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| Edición: | 1st ed |
| Colección: | Springer eBooks.
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| Acceso en línea: | Conectar con la versión electrónica |
| Ver en Universidad de Navarra: | https://innopac.unav.es/record=b33002319*spi |
Tabla de Contenidos:
- 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.
