Genotoxicity and Carcinogenicity Testing of Pharmaceuticals

• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Άλλοι συγγραφείς: Graziano, Michael J. (Επιμελητής έκδοσης), Jacobson-Kram, David (Επιμελητής έκδοσης)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2015.
• Έκδοση: 1st ed. 2015.
• Θέματα: Medicine.; Cancer research.; Pharmaceutical technology.; Biomedicine.; Cancer Research.; Pharmaceutical Sciences/Technology.

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...

Πίνακας περιεχομένων:

• 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.