Bioequivalence and Bioavailability Forum • Ibuprofen product-specific bioequivalence guidance EMA

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

posted by dshah – India, 2021-09-27 12:22 (1164 d 14:51 ago) – Posting: # 22600
Views: 3,121

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Previously the sponsor may have followed draft guidance, but on current time it is recommended to follow final guidance.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 [Regulatives / Guidelines]
- 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