Bioequivalence and Bioavailability Forum • FDA guidance for bioanalytical run

samar sameh
☆

Jordan,
2017-10-22 18:19
(2371 d 12:42 ago)

Posting: # 17903
Views: 3,657

FDA guidance for bioanalytical run [Regulatives / Guidelines]

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

xiaodongwang
☆

China,
2017-10-23 12:42
(2370 d 18:18 ago)

@ samar sameh
Posting: # 17907
Views: 3,014

FDA guidance for bioanalytical run

Post reply

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.”

Ruba
☆

Jordan,
2017-10-24 11:14
(2369 d 19:47 ago)

@ samar sameh
Posting: # 17910
Views: 2,906

FDA guidance for bioanalytical run

Post reply

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

Dear Samar

i think as per FDA guideline; it is allowed to exclude Upper limit of quantitation BUT not LLOQ. below is FDA quote

The acceptance criterion for the standard curve is that at least 75% of non-zero standards should meet the above criteria, including the LLOQ. Excluding an individual standard should not change the model used. Exclusion of calibrators for reasons other than failing to meet acceptance criteria and assignable causes is discouraged.

i am not sure if other Colleagues has other views :-)

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]