and now that we are at it [Bioanalytics]

posted by ElMaestro  – Belgium?, 2018-11-05 18:19 (724 d 01:42 ago) – Posting: # 19533
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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 :-)

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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