Drug concentration <LLQ [Bioanalytics]

posted by GM – India, 2018-06-29 03:47 (889 d 19:45 ago) – Posting: # 18992
Views: 2,482

Hello All,

Hope all are doing well.

As per the Bioanalytical guidance of FDA, all values <LLQ should be declared as zero.

But my doubt is, is there any possibility to use the actual values measured for calculating key parameters?

If yes, how this can be justify?

B’coz, we are not getting best fit (Rsq<0.8) when considering zero instead of actual values.

Thankyou in advance.


Best Regards,

Complete thread:

 Admin contact
21,240 posts in 4,431 threads, 1,482 registered users;
online 7 (1 registered, 6 guests [including 3 identified bots]).
Forum time: Friday 23:33 UTC (Europe/Vienna)

I believe there is no philosophical high-road in science,
with epistemological signposts. No, we are in a jungle
and find our way by trial and error,
building our road behind us as we proceed.    Max Born

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