T/R potency <5% [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-09-09 12:48 (86 d 01:56 ago) – Posting: # 23282
Views: 743

Hi Achievwin!
Unlike Health Canada, there is no provision for potency correction in FDA.
So if the difference is more, there is higher probability to find difference in PK parameters for treatments, which ultimately affects BE outcome.
It's best to have less difference in Assay of Test and Reference for any BE study.
Regards,
Divyen

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