Genotoxicity and Carcinogenicity Testing of Pharmaceuticals /

Detalles Bibliográficos
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Graziano, Michael J. (Editor ), Jacobson-Kram, David. (Editor )
Formato: eBook
Lenguaje:English
Publicado: Cham : Springer International Publishing : Imprint: Springer, 2015.
Edición:1st ed. 2015.
Materias:
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.