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

Publication | Open Access

DOI Full Paper Access

Citations

References

2013

Year

Karen M. Alsante, Kim Huynh‐Ba, Steven W. Baertschi, Robert A. Reed, Margaret S. Landis, Mark H. Kleinman, Christopher Foti, Venkatramana M. Rao, Paul Meers, Andreas Abend,

AAPS PharmSciTech

Chemical EngineeringPart 1Active IngredientMedicineDrug DiscoveryDrug PurityPharmaceutical TechnologyPharmaceutical Dosage FormsToxicologyImpurity ConsiderationsPharmacologyChromatography