LLOQ based on ‘worst case’ Cmax [Bioanalytics]

posted by ElMaestro  – Denmark, 2021-12-21 15:48 (152 d 06:26 ago) – Posting: # 22708
Views: 749

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:

UA Flag
Activity
 Admin contact
22,091 posts in 4,630 threads, 1,566 registered users;
online 14 (0 registered, 14 guests [including 11 identified bots]).
Forum time: Sunday 23:14 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5