least common multiple of T and R [Design Issues]

posted by Vishal S – India, 2021-05-25 15:26 (622 d 15:43 ago) – Posting: # 22365
Views: 1,306

Hii Helmut

Thank you for replay
we are designing the fixed dose combination Immediate release test formulation(A+B) having strength 100 mg (A) and 325 mg (B), RLD for FDC formulation not approved in EU market & not available so we are using two different RLDs ie RLD (A) of 100 mg strength and RLD (B) having 500 mg strength. Note than RLD (B) available in EU market in 500 mg strength, 325 mg strength not available as RLD.
please guide me for BE study for same

Thanks and Regards
Vishal S


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]

Complete thread:

UA Flag
Activity
 Admin contact
22,481 posts in 4,710 threads, 1,603 registered users;
24 visitors (0 registered, 24 guests [including 8 identified bots]).
Forum time: 06:10 CET (Europe/Vienna)

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

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