Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

ANVISA guidance [Regulatives / Guidelines]

posted by Priyanka_S – 2010-03-20 12:09 (4939 d 09:41 ago) – Posting: # 4945
Views: 3,652

Dear HS,

For ANVISA submission, If more than 10% of samples (plasma concentrations) are missing in one period then do we need to give the the BE result both including & excluding that subject?

—
Best Regards

Priyanka S

Complete thread:

ANVISA guidancePriyanka_S 2010-03-20 11:09 [Regulatives / Guidelines]
- ANVISA guidance bharat 2010-03-22 10:40
- ANVISA guidance Dr_Dan 2010-04-01 15:34
  - Bioanalysis of dropouts, etc. Helmut 2010-04-01 15:56

Admin contact
22,761 posts in 4,775 threads, 1,628 registered users;
17 visitors (0 registered, 17 guests [including 4 identified bots]).
Forum time: 22:50 CEST (Europe/Vienna)

Medical researches can be divided into two sorts:
those who think that meta is better and those
who believe that pooling is fooling. Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz