Mutagenic Impurities from a Drug Substance Perspective: Highlights from ICH M7 Q&A Draft Document
23:25
Drug Substance Postapproval Changes Guidance: Determination of Impurity Profile Equivalence
15:03
Review of Secondary Type II Drug Master Files
21:51
Safety Evaluation of Drug Substance Impurities in Generics
20:33
ICH M7(R1) – Chemistry and Manufacturing Control (CMC) Perspective on Hazard Assessment
25:35
Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification
22:06
ICH Q11 Q&A - A Supporting Document for the Selection and Justification of Starting Materials
29:03
Drug Master File (DMF) Submissions on New FDA Form 3938
13:26