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[PDF] Bioavailability and Bioequivalence Studies Submitted in - FDA

The guidance referred to in this footnote, as well as others referenced throughout the remainder of the document, can be found on the FDA Drugs guidance Web 

[PDF] Bioequivalence Studies with Pharmacokinetic Endpoints for - FDA

Please refer to FDA's guidance for industry SUPAC: Modified Release Solid Oral Dosage Forms, Chemistry Manufacturing and Controls; In Vitro Dissolution 

[PDF] FDAs Experience on IVIVC

➢FDA's Experience in IVIVC o Type of submissions lieu of required in vivo studies, leading to: o Time/Cost savings in vitro release acceptance criteria 

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