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Tag: BA/BE data submission format

CDSCO Guidelines on BA/BE Studies: Regulatory Framework for India

Posted on May 14, 2025 digi By digi

CDSCO Guidelines on BA/BE Studies: Regulatory Framework for India Regulatory Overview of BA/BE Studies under CDSCO Guidelines in India Bioavailability (BA) and Bioequivalence (BE) studies play a critical role in establishing therapeutic equivalence between a generic drug and its innovator counterpart. In India, the Central Drugs Standard Control Organization (CDSCO) regulates the conduct of these…

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CDSCO (India) Guidelines, Regulatory Guidelines

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