The International Generic Drug Regulators Programme (IGDRP) has published a Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report Template. Regulatory authorities participating in the IGDRP Bioequivalence Working Group often have differing requirements for biowaivers based on the BCS. The template was developed for use by IGDRP members to ensure that the relevant information for a BCS biowaiver is consistently taken into account during assessment.
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