and now that we are at it [Bioanalytics]

posted by ElMaestro  – Denmark, 2018-11-05 18:19 (853 d 06:32 ago) – Posting: # 19533
Views: 5,259

Hello nobody,

it is at the LLOQ the magic is needed. This is where the s:n is measured, also.

At present we have about 70 companies pursuing Tiotropium/Formoterol/Salmeterol/Fluticasone/and so forth approvals and for some of those methods we need an LLOQ of 0.1 pg/mL and not one iota less; even with the API6500 Qtrap and similar equipment this is at the border. The opportunity for assay optimizations have been exhausted (including columns, derivatization, SPE/LLE, and much mnore has been explored), the agency might not approve higher doses than a single shot per subject per period and we need to bear in mind that Cmax/LLOQ should be 20 or better.

You try and see if you can find a way to get approval for Tiotropium with e.g. 0.5 pg/mL. Good luck when meeting the agency :-D

So, in as much as I agree with you that LLOQ should not ever be an issue, LLOQ is a persistent issue. But of course, that really isn't what this thread is all about :-)

Pass or fail!

Complete thread:

 Admin contact
21,371 posts in 4,463 threads, 1,496 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Monday 00:52 CET (Europe/Vienna)

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 and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz