Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

Potency Correction [Regulatives / Guidelines]

posted by joyjac – Philippines, 2008-08-15 05:03 (6528 d 11:56 ago) – Posting: # 2190
Views: 5,960

Dear colleagues,

Would you know if EMEA allows or accepts BE data that has been normalized or corrected to account for any potency differences between the reference and generic product?

Thanks.

Complete thread:

Potency Correctionjoyjac 2008-08-15 03:03
- Potency Correction (EMEA) Helmut 2008-08-15 13:11
  - Potency Correction (EMEA) Helmut 2008-08-21 18:35

Admin contact
23,656 posts in 4,994 threads, 1,571 registered users;
228 visitors (0 registered, 228 guests [including 16 identified bots]).
Forum time: 16:59 CEST (Europe/Vienna)

It requires a very unusual mind
to undertake the analysis of the obvious. Alfred North Whitehead

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz