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FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence
Quantitative Methods for Determining Equivalence of Particle Size Distributions
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
Navigating First ICH Generic Drug Draft Guideline M13A Bioequivalence for IR Solid Oral Dosage Forms
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 1
Analyzing FDA's statistical review of a Phase 3 program
Does FDA have any tips on preparing powdered formula coming from other countries?
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 1
A Deep Dive: GDUFA III Scientific Meetings
PBPK modeling approaches to assess risks associated with bioequivalence in drug development
New Biosimiliars Guidance- Has Anything Changed? Webinar
2021 LAI Workshop Session 3 Presentations
