ISR sample selection [Bioanalytics]

posted by Ohlbe – France, 2018-11-29 17:50 (972 d 04:25 ago) – Posting: # 19661
Views: 2,203

Dear Smitha,

» How appropriate is it to generate another set of data for a critical PK parameter as Cmax? (even if the guidelines indicate that these values should not be used for study conclusion).

I don't see a real problem here: as you say, the guidelines clearly indicate that the ISR value should not be used for the PK/stats.

Actually, it sort of helps to avoid some other issues. If you write in your SOP that you will systematically repeat the Cmax sample, there will be no discussion regarding how you selected the samples to be re-analysed and possible bias in sample selection.

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,590 posts in 4,513 threads, 1,531 registered users;
online 9 (0 registered, 9 guests [including 6 identified bots]).
Forum time: Wednesday 23:16 CEST (Europe/Vienna)

If a man will begin with certainties, he will end in doubts;
but if he will be content to begin with doubts,
he will end in certainties.    Francis Bacon

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