Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018
40:26
Benefit-Risk Considerations During Drug Product Development (8of14) REdI 2018
1:20:20
Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017
44:31
Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6of14) REdI 2018
33:18
Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018
1:56:15
Understanding FDA Inspections and Data
1:29:39
Bench to Bedside Chats: Guidance for Industry CGMP for Phase 1 Investigational Drugs
1:57:16
M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance
4:38:30