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RegisterLLOQ: higher or lower? [Bioanalytics]
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
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
Complete thread:
- LLOQ: higher or lower? Beholder 2017-11-30 15:14 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- LLOQ: higher or lower? cakhatri 2017-12-04 09:52
- LLOQ: higher or lower? BE-proff 2017-12-07 09:25
- 32=2^5 half lives mittyri 2017-12-07 15:57
- 32=2^5 half lives cakhatri 2017-12-11 07:39
- 32=2^5 half lives mittyri 2017-12-07 15:57
- LLOQ: higher or lower?xtianbadillo 2018-01-18 15:51
- LLOQ: higher or lower? BE-proff 2017-12-07 09:25
- LLOQ: higher or lower? cakhatri 2017-12-04 09:52
Ing. Helmut Schütz