long half-life and large variability [Regulatives / Guidelines]

posted by dshah – India, 2020-08-10 06:18 (277 d 12:58 ago) – Posting: # 21846
Views: 1,421

Hi All!

I believe there are few MR drug with high variability and still USFDA recommends partial or fully replicate design. Mesalamine PSG or
Mesalamine PSG for 800 mg strength
Considering the Mechanism of Action, PK variability, non-Linearity- the study and formultion could indeed be challenging.

Regards,
Dshah

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