Bioequivalence and Bioavailability Forum • LLOQ based on ‘worst case’ Cmax

LLOQ based on ‘worst case’ Cmax [Bioanalytics]

posted by ElMaestro – Denmark, 2021-12-21 16:48 (1079 d 08:19 ago) – Posting: # 22708
Views: 3,364

Hi Helmut,

did you consider plnorm in stead of simulations:


Mean=100

CV=.2

V=log(1+CV*CV)

SD.logscale=sqrt(V) 

MN.logscale=log(Mean/20)-0.5*V 

LLOQ=5

probablity.of.problem = 1-plnorm(LLOQ, mean=MN.logscale, sd=SD.logscale) #or use the upper tail

Did not check the equations. Assuming they are ok, I just thought I'd offer a shorthand on their basis, quick and dirty. :-)

—
Pass or fail!
ElMaestro

Complete thread:

Analytical range LOQ Farmacevt 2021-12-20 20:54 [Bioanalytics]
- Analytical range LOQ ElMaestro 2021-12-20 22:46
  - Analytical range LOQ Farmacevt 2021-12-22 22:02
- Analytical range LOQ dshah 2021-12-21 12:03
- LLOQ based on ‘worst case’ Cmax Helmut 2021-12-21 13:31
  - LLOQ based on ‘worst case’ CmaxElMaestro 2021-12-21 15:48
    - LLOQ based on ‘worst case’ Cmax Helmut 2021-12-22 23:16