Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2018-05-22 06:34 CEST (UTC+2h)
 

Bioequivalence of IR vs MR tablet [Design Issues]

posted by heritage - India, 2018-05-05 06:25  - Posting: # 18755
Views: 506

One drug has been approved as IR tablet given 100 mg bid (total dose 200 mg). We want to make one ER formulation of 230 mg which can be given once daily. I need help in following issues

1. What should be the design?
2. Which PK parameter I should be looking at?
3. Should I do fasting or fed study?
4. Should I targeting BE in Cmax or AUC?

Please give me some reading material or link to any post wherein this had been already discussed

Thanks in advance


Edit: Category changed; see also this post #1. [Helmut]

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
18,275 posts in 3,884 threads, 1,164 registered users;
17 users online (0 registered, 17 guests).

Bones, I want the impossible checked out too.    William Shatner (as James T. Kirk)

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed