Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms
Titel:
Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms
Auteur:
Alsante, Karen M. Huynh-Ba, Kim Baertschi, Steven W. Reed, Robert A. Landis, Margaret S. Kleinman, Mark H. Foti, Christopher Rao, Venkatramana M. Meers, Paul Abend, Andreas Reynolds, Daniel W. Joshi, Biren K.