Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products

The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.

Related Content:

AnalyticsFormulation and Drug DeliveryManufacturingQuality SystemsDrug DevelopmentPharmaceutical Technology-02-02-2005

A CDMO’s Role in API Quality

FDA Grants Fast Track Designation to Teva Celiac Disease Candidate

GSK, Spero Therapeutics Oral UTI Treatment Trial Stopped Early for Efficacy