Bioequivalence and Bioavailability Forum • PK Vs Analytical

PK Vs Analytical [Bioanalytics]

posted by Charl – 2007-07-31 16:07 (6488 d 18:42 ago) – Posting: # 947
Views: 12,100

❝ Should also be based on the PK profile

Dear Dr. Shiv

❝ Determination of Lower Limit of Quantitation (LLOQ)

❝ LLOQ should be sufficiently low to allow characterization of 4-5 T1/2

this is general, instrument sensitivity might not allow us to go to the disered LLOQ if we are chasing only a 4-5 T1/2.

❝ LLOQ should allow proper characterization of baseline levels of endogenous substance (unless they are insignificant, eg., less than 5% of Cmax)

❝ LLOQ values should be less than 5% of observed Cmax

in what since you are conecting LLOQ to be 5% les than Cmax, I conclude from your words that my entire linearty range lies in the 5% region??? :-|

❝ Examples of LLOQ determination methods:

❝ Expected mean Cmax divided by 32 (represents 5 T1/2 assuming a one-compartment model)

what if am working on non-compartmental model does this still apply.... ;-)