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Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
Review of Clinical Endpoint Bioequivalence Studies in ANDAs (17/28) Generic Drugs Forum 2017
Case Studies: Inadequate Bioequivalence Studies (18of28) Generic Drugs Forum – Apr. 3-4, 2019
In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of IVRT and IVPT
Product-Specific Guidance Fundamentals from a Clinical Perspective
Best Practices for Conducting Bioequivalence Studies (16of27) Generic Drugs Forum 2018
In Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches
Topical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches
Developing and Implementing Science-Based Standards in Bioequivalence Assessment
Best Practices for Conducting Bioequivalence Studies Slide FDA Generic Drug Forum 2018
An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 1