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AGDD 2024 | D2S11 - ICH M13A: First ICH Guideline for Bioequivalence
ICH M13B BIOEQUIVALENCE FOR IMMEDIATE RELEASE SOLID ORAL DOSAGE FORMS ADDITIONAL STRENGTHS BIOWAIVER
Considerations in Assessing Generic Drug Products of Oral Dosage Forms
ICH M13A Guidance for Bioequivalence Studies
ICH M13A Guidance for Bioequivalence Studies in Detail
Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms
AGDD 2024 | D2S02 - Quality Considerations for First Generic Oral Liquids
GDF2026 - ICH M13A High-Risk vs. Low-Risk Case Studies – Bioequivalence (BE) Implications
Good ANDA Submission and Assessment Practices and Software Support- FDA Generic Drug Forum 2018
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 1
GDF2025 – D2S05 - Impact of ICH M13A Implementation on Bioequivalence Assessment
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Last Updated: October 3, 2026
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Summary
This webinar provided an in-depth look into the This presentation provided an overview of the M13 FDA discusses considerations in assessing Min Li, PhD, Acting Biopharmaceutics Lead for the Division of Biopharmaceutics, discusses the scientific and risk-based ... This presentation assessed Critical Quality Attributes (CQA) risks for This public workshop communicated how FDA's ... presentation introduced the recent
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