Toxicity testing of impurities and metabolites

Bibliographic Details
Main Author: Black, Kurt A.
Format: eBook
Language:English
Published: London Henry Stewart Talks 2009, 2009
Series:Non-clinical testing for toxicity of pharmaceuticals : regulatory and practical standards for testing and application
Subjects:
Online Access:
Collection: Henry Stewart Talks - Collection details see MPG.ReNa
Table of Contents:
  • Types of impurities and regulatory framework
  • Qualification of impurities
  • Special considerations for genotoxic impurities
  • Residual solvents and drug product degradants
  • Safety assessment of drug metabolites