Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification
20:33
ICH M7(R1) – Chemistry and Manufacturing Control (CMC) Perspective on Hazard Assessment
28:12
Regulatory Considerations for Impurity Qualification: ICH Q3A/Q3C/Q3D, RLD & MDD
21:51
Safety Evaluation of Drug Substance Impurities in Generics
22:06
ICH Q11 Q&A - A Supporting Document for the Selection and Justification of Starting Materials
1:22:14
Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
12:22
Mutagenic Impurities from a Drug Substance Perspective: Highlights from ICH M7 Q&A Draft Document
36:56
FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy
25:40