A Biowaiver for a topical dosage form refers to regulatory approval for marketing a generic topical product without conducting in vivo bioequivalence (BE) studies. Instead, equivalence is demonstrated using in vitro methods and other scientific justifications. Key Considerations for Biowaiver of Topical Dosage Forms Regulatory agencies such as USFDA, EMA, and WHO provide guidelines for…
When BE is demonstrated for one strength of a drug product, regulatory agencies allow a biowaiver for additional strengths under certain conditions. The key criteria vary across USFDA, EMA, WHO, MHRA, TGA, and CDSCO but are largely aligned on fundamental principles. USFDA Biowaiver Criteria Biowaiver is allowed for additional strengths if: EMA Biowaiver Criteria Follows…
A biowaiver allows a generic drug to be approved without an in vivo (BE) study based on in vitro dissolution data. This is particularly applicable BCS Class 1 drugs, which have high solubility and high permeability. Biowaiver Justification for BCS Class 1 Drugs To obtain a biowaiver for a BCS Class 1 drug, the following…
Bioequivalence (BE) studies are crucial in the pharmaceutical industry to ensure that generic formulations exhibit comparable bioavailability to their reference products. Several factors influence BE results, potentially impacting regulatory approval and market entry. This review highlights the key determinants affecting BE outcomes, including formulation characteristics, physiological variability, study design, and analytical considerations. Formulation Factors The…
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