FDA guidance for bioanalytical run [Regulatives / Guidelines]

posted by xiaodongwang – China, 2017-10-23 12:42 (2348 d 10:08 ago) – Posting: # 17907
Views: 2,978

Dear Samar:

❝ Does this apply for FDA submissin, meaning:can we exclude the ULOQ and the LLOQ from calibration range ?


FDA guidance “Matrix-based standard calibration samples: 75%, or a minimum of six standards, when back-calculated (including ULOQ) should fall within ±15%, except for LLOQ, when it should be ±20% of the nominal value. Values falling outside these limits can be discarded, provided they do not change the established model.

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
79 visitors (0 registered, 79 guests [including 7 identified bots]).
Forum time: 21:51 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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