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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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Graziano, Michael J. (Editor ), Jacobson-Kram, David (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Cham : Springer International Publishing : Imprint: Springer, 2015.
Edición:1st ed. 2015.
Temas:
Cancer.
Pharmaceutical chemistry.
Cancer Biology.
Pharmaceutics.
Acceso en línea:Texto Completo
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.

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