Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

Ibuprofen product-specific bioequivalence guidance EMA [Regulatives / Guidelines]

posted by dshah – India, 2021-09-27 12:22 (1730 d 22:41 ago) – Posting: # 22600
Views: 5,111

Dear qualityassurance!
Kindly follow the final product specific bioequivalence guidance.
Previously the sponsor may have followed draft guidance, but on current time it is recommended to follow final guidance.
Regards,
Dshah

Complete thread:

Ibuprofen product-specific bioequivalence guidance EMA qualityassurance 2021-09-26 07:45
- Ibuprofen product-specific bioequivalence guidance EMAdshah 2021-09-27 10:22
- Undeliverable e-mail Helmut 2021-09-27 14:52
- Enantioselective assay – really? Helmut 2021-09-27 15:55
  - Enantioselective assay – really? qualityassurance 2021-10-12 15:15

Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
105 visitors (0 registered, 105 guests [including 12 identified bots]).
Forum time: 11:04 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