Bioequivalence and Bioavailability Forum 05:05 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

FDA guidance for bioanalytical run [Regulatives / Guidelines]

posted by samar sameh - Jordan, 2017-10-22 16:19  - Posting: # 17903
Views: 1,624

Dear Colleagues
I need your your help with the followings:
Regarding bioanalytical run, EMA states the following:
If the rejected calibration standard is the LLOQ, the LLOQ for this analytical run is the next lowest acceptable calibration standard of the calibration curve. If the highest calibration standard is rejected,the ULOQ for this analytical run is the next acceptable lower calibration standard of the calibration curve. The revised calibration range must cover all QC samples (low, medium and high).
Does this apply for FDA submissin, meaning:can we exclude the ULOQ and the LLOQ from calibration range ?

Samar

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,698 posts in 3,983 threads, 1,237 registered users;
online 9 (0 registered, 9 guests [including 6 identified bots]).

When puzzled, it never hurts to read the primary documents –
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed