Reference Scale Average Bioequivalence Approach: ANVISA, Brazil [Regulatives / Guidelines]

posted by Maitri – India, 2018-09-21 19:49 (1343 d 00:18 ago) – Posting: # 19297
Views: 2,044

Hello,

Can any one comment on acceptability of Reference Scale Bioequivalence Approach for ANVISA ( Regulatory agency of Brazil) for highly variable drugs? Do they accept RSABE study design for Highly variable drug compounds?

Thanks & Regards,
Maitri Sanghavi

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