Bioequivalence and Bioavailability Forum • Confusing guidance

Confusing guidance [Regulatives / Guidelines]

posted by nobody – 2019-09-25 15:36 (1840 d 18:02 ago) – Posting: # 20648
Views: 5,254

imho the authority wants you to be AWARE that there is a (reversible? during plasma preparation? storage? under chromatographic conditions?) glucuronidation relevant for the compound. Did you have a look at the PAR or alike for PK details?

—
Kindest regards, nobody

Complete thread:

Ezetimibe BE Mutasim 2019-09-23 14:40 [Regulatives / Guidelines]
- Ezetimibe BE Helmut 2019-09-23 15:36
- Confusing guidance Helmut 2019-09-25 11:52
  - Confusing guidancenobody 2019-09-25 13:36
- Ezetimibe final guidance Helmut 2019-09-28 12:11
  - Ezetimibe final guidance Ohlbe 2019-09-30 11:03
    - Ezetimibe final guidance Helmut 2019-09-30 15:33
- Ezetimibe BE ElMaestro 2019-09-30 13:12
  - Ezetimibe BE Helmut 2019-09-30 15:26