Reanalysis for PK Reason: Gone with the Wind [Bioanalytics]

posted by Obinoscopy  – USA, 2020-07-16 23:48 (1405 d 20:13 ago) – Posting: # 21723
Views: 5,409

Hi Ohlbe

❝ Confirming the presence of the analyte in a pre-dose sample could be relevant for other types of studies (and even worse, finding analyte in a placebo-treated subject, or animal in a TK study).


Besides non-BE studies, I also noticed that reanalysis to confirm the presence of the analyte in a pre-dose sample is allowed by some BE assessors. Do you think those group of BE assessors are inconsistent? I ask this because, the same assessors will not accept reanalysis of post-dose samples to correct an irregular PK profile.

Scopy

Complete thread:

UA Flag
Activity
 Admin contact
23,035 posts in 4,835 threads, 1,643 registered users;
24 visitors (0 registered, 24 guests [including 5 identified bots]).
Forum time: 20:02 CEST (Europe/Vienna)

Satisfaction of one’s curiosity is one of the greatest sources
of happiness in life.    Linus Pauling

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