Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
26:19
Common CMC Issues in Type II DMFs and How to Avoid Them
2:35:24
An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs
2:25:28
Navigating First ICH Generic Drug Draft Guideline M13A Bioequivalence for IR Solid Oral Dosage Forms
22:52
ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues
5:36:30
April 28, 2023 Meeting of the Oncologic Drugs Advisory Committee (ODAC)
1:47:20
FDA Clinical Investigator Training Course (CITC) 2024 – Day Three – Session Two
2:01:02
FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence
19:15