
FDA Publishes Guidance on Biopharmaceutics Classification System-Based Biowaivers
The guidance document gives recommendations to support biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of the in-vivo bioequivalence study requirement for drugs.
FDA published
According to FDA, if two drugs contain the same drug substance, they are bioequivalent if the rate and extent of drug absorption after administration in the same molar dose are within the acceptable predefined limits. Using a BCS-based biowaiver approach reduces the need for in-vivo studies to determine bioequivalence and may reduce costs and increase efficiency in generic drug development. This approach applies to immediate release, solid orally administered dosage forms or suspensions that deliver the drug to the systemic circulation. Fixed-dose combination products may be eligible if all active drug substances fulfill the criteria. Drugs with a narrow therapeutic index are not eligible for the BCS-based biowaiver.
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