Incurred sample reanalysis [Regulatives / Guidelines]

posted by sushil.pimpare – India, 2017-06-06 09:53 (2949 d 14:44 ago) – Posting: # 17446
Views: 5,284

After ISR investigation (for the samples those are having % difference more that 50 %), Can we report and consider ISR value for PK and Stat analysis if it is mentioned in the SOP?

Complete thread:

UA Flag
Activity
 Admin contact
23,426 posts in 4,929 threads, 1,682 registered users;
44 visitors (0 registered, 44 guests [including 32 identified bots]).
Forum time: 00:37 CEST (Europe/Vienna)

You can do one of two things; just shut up,
which is something I don’t find easy,
or learn an awful lot very fast,
which is what I tried to do.    Jane Fonda

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