Safety Evaluation of Drug Substance Impurities in Generics
23:56
Administrative Aspects of Managing a Drug Master File (DMF)
28:12
Regulatory Considerations for Impurity Qualification: ICH Q3A/Q3C/Q3D, RLD & MDD
33:49
Panel Discussion – Drug Master File and Drug Substance Workshop
25:35
Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification
22:14
Synthetic Therapeutic Peptide APIs: Documentation for API Sameness & Related Impurities
1:20:20
Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017
25:40
Impurity Case Studies: Pharmacology/Toxicology (22of28) Generic Drugs Forum – Apr. 3-4, 2019
13:26