Bioequivalence and Bioavailability Forum

kaushal09 ☆ India, 2008-12-24 06:03 (6392 d 05:59 ago) Posting: # 2967 Views: 3,377	LLOQ selection [Bioanalytics] Post reply
	Dear all, LLOQ (lower limit of Quantification) can be 1/20th or 1/32th or 1/10th of Cmax can be acceptable for study. if in study LLOQ was only 1/10th of Cmax than it can be acceptable. there is any reference for selection of LLOQ. regards, Kaushal.

Helmut
★★★

Vienna, Austria,
2008-12-24 13:38
(6391 d 22:24 ago)

@ kaushal09
Posting: # 2972
Views: 2,742

Working range based on PK!

Post reply

Dear Kaushal!

❝ LLOQ (lower limit of Quantification) can be 1/20th or 1/32th or 1/10th of

❝ Cmax can be acceptable for study.

Indeed - but does it make any sense?
Please see this post and one of my recent lectures. The working range of the method should be based on the PK of the analyte (drug/metabolite).

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LLOQ selection [Bioanalytics]

Working range based on PK!