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USFDA’s Draft Guidance: Bioequivalence Biowaivers for Additional Strengths of Immediate-Release Oral Drugs
Developing drug products across multiple strengths is a common strategy in pharmaceutical formulation, allowing dose flexibility and...

Sharan Murugan
May 302 min read
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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
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