FDA: RSABE for NTID [RSABE / ABEL]

posted by Jay – India, 2018-04-02 06:28 (1304 d 16:08 ago) – Posting: # 18628
Views: 6,111

Thanks, John for the reply...

I would like to understand that how come the study passing in ABE within 80% to 125%, low T/R and low ISCV would not meet the BE criteria of scaled average bioequivalence.

As we generally proceed with scaled approach when the ISCV is high (more than 30%) and would not meet BE criteria with ABE approach.

Please let me know your views on the same.

Regards,
Jay

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