LLOQ: higher or lower? [Bioanalytics]

posted by xtianbadillo – Mexico, 2018-01-18 16:51 (2346 d 09:16 ago) – Posting: # 18215
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As Cakhatri said a proper LLOQ let you a proper estimation of AUC0-t and AUC0-inf and to avoid BLQ. "for bioequivalence studies the LLOQ should be not higher than 5% of the Cmax, while such a low LLOQ may be not necessary for exploratory pharmacokinetic studies EMA" for BE at least 80% of AUC0-inf is required, so a low LLOQ is recommended.

In my experience I go for -2SD of the Cmax and the result result is divided by 20:
For instance Cmax 1000 +/-100, so 800/20 = LLOQ = 40; in this example, according to EMA should be not higher than 50, so 40 is OK

Doing this I have reduced my BLO;

1000/32 = 31.25 is better than 40 :-)

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