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

posted by dshah  – India, 2020-08-10 08:18 (1786 d 08:17 ago) – Posting: # 21846
Views: 3,830

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

Complete thread:

UA Flag
Activity
 Admin contact
23,425 posts in 4,928 threads, 1,679 registered users;
55 visitors (0 registered, 55 guests [including 10 identified bots]).
Forum time: 16:36 CEST (Europe/Vienna)

Fools with Tools Are Still Fools!    Anonymous

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5