Predose study samples [Bioanalytics]

posted by babu – India, 2009-02-04 14:57 (6355 d 22:04 ago) – Posting: # 3180
Views: 3,382

Hai reddy,

There is no acceptance criteria for predose samples.
But predose sample also considered as blank matrix. So we have criteria for interference in blank matrix (selectivity) mentioned in FDA guidelines. So same will be applicable for predose sample also. However you should follow as per your predefined inhouse SOPs.

with regards,
Rambabu.S


Edit: Full quote removed. Please see this post! [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
248 visitors (0 registered, 248 guests [including 15 identified bots]).
Forum time: 14:01 CEST (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

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