BE study on recommended dose strength [Regulatives / Guidelines]

posted by Mahesh M – India, 2013-12-26 08:53 (4562 d 18:28 ago) – Posting: # 12109
Views: 2,384

Dear all,

Can we demonstrate BE study on recommended dose strength if there is no safety issue?

Eg:
Reference drug are available in two strength 180 mg and 360 mg.
Its recommended dose is 720 mg in SPC.
Then at what dose one should assess BE for such drug? single tablet (360 mg dose) or 2 tablets (360 X2 = 720mg dose).
(There is no safety issue and analytical issue, PK can be well characterized with single dose also.)

kindly suggest

Regards
Mahesh

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
139 visitors (0 registered, 139 guests [including 36 identified bots]).
Forum time: 04:22 CEST (Europe/Vienna)

Scientists often have a naïve faith that
if only they could discover enough facts about a problem,
these facts would somehow arrange themselves
in a compelling and true solution.    Theodosius Dobzhansky

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