Search
ICH M13B Guideline: Additional Strengths Biowaiver for Immediate-Release Solid Oral Dosage Forms
ICH M13B Guideline: Additional Strengths Biowaiver for Immediate-Release Solid Oral Dosage Forms The European Medicines Agency (EMA) has adopted the ICH M13B Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Additional Strengths Biowaiver, together with a related Questions and Answers (Q&A) document. The guideline provides recommendations for obtaining a biowaiver for one or more additional strengths when in vivo pharmacokinetic bioequivalence or eff
Sharan Murugan
Sep 264 min read
USFDA Guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Recently 30th October, 2025 the U.S. Food and Drug Administration (FDA) issued guidance titled " M13A: Bioequivalence for...
Sharan Murugan
Nov 1, 20242 min read
ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
The USFDA released draft guidance for the industry on January 31, 2023, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage...
Sharan Murugan
Feb 1, 20231 min read