importance of bioanalytical validation [Bioanalytics]

posted by averroes1304 – Morocco, 2019-03-27 12:55 (1818 d 15:20 ago) – Posting: # 20091
Views: 5,930

(edited by mittyri on 2019-03-27 13:51)

Dear all,

could you explain to me the importance of bioanalytical validation in bioequivalence studies? is it really critical and important to perform the bioanalytical validation exercise? knowing that the purpose of bioequivalence studies is only to highlight differences in bioavailability between the test and reference drug and that this difference will be highlighted in all cases even with an invalidated analytical method and that chance cannot be the only factor in case of bioequivalence between two drugs with an invalidated analytical method..... is it scientifically acceptable to use analytical methods published in the literature?

Best regards,


Edit: Category changed; see also this post #1[Mittyri]

Complete thread:

UA Flag
Activity
 Admin contact
22,940 posts in 4,812 threads, 1,639 registered users;
39 visitors (0 registered, 39 guests [including 7 identified bots]).
Forum time: 04:15 CET (Europe/Vienna)

Those people who think they know everything
are a great annoyance to those of us who do.    Isaac Asimov

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