Reference Scale Average Bioequivalence Approach: ANVISA, Brazil [Regulatives / Guidelines]
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
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
Complete thread:
- Reference Scale Average Bioequivalence Approach: ANVISA, BrazilMaitri 2018-09-21 19:49 [Regulatives / Guidelines]
- RSABE - ANVISA d_labes 2018-09-22 14:11