importance of bioanalytical validation [Bioanalytics]

posted by ElMaestro  – Denmark, 2019-03-27 12:08 (1157 d 07:13 ago) – Posting: # 20092
Views: 4,827

Hello Averroes,

if you cannot reliably determine the concentrations in PK samples, then you cannot reliably evaluate bioequivalence. At the end of the day the comparative evaluation of rate and extent of absorption is based on quantification in PK samples.

Thus, in highly regulated markets you will not see products approved unless the reliability of the assay has been confirmed by a validation. Check also ICH E6 e.g. §2.2 and §2.5 or similar entries in WHO's set of practices.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
22,110 posts in 4,630 threads, 1,567 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Friday 20:21 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5