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

posted by dshah – India, 2020-08-10 06:18 (105 d 15:24 ago) – Posting: # 21846
Views: 1,065

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:

Activity
 Admin contact
21,205 posts in 4,425 threads, 1,481 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Monday 20:43 CET (Europe/Vienna)

Intellect distinguishes between the possible and the impossible;
reason distinguishes between the sensible and the senseless.
Even the possible can be senseless.    Max Born

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