Bioequivalence and Bioavailability Forum 02:34 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Non-compartmental analysis [Regulatives / Guidelines]

posted by M.tareq - 2017-12-31 17:17  - Posting: # 18130
Views: 985

Dear all,

As per guidelines "Non-compartmental methods should be used for determination of pharmacokinetic parameters in
bioequivalence studies. The use of compartmental methods for the estimation of parameters is not
acceptable"

why the non-Compartmental analysis is preferred over compartmental ones ?

also use of PK/PD models to establish BE, as per my understanding BE is about detecting differences between formulations in healthy volunteers and from that, it can be extended to patients population.

PK/PD models can't be used to detect such differences? and conclude BE?



Also regarding use of pop/INDV BE, most FDA OGD drafts revolve around use of average BE in most cases and in case of HVDP, reference scaling and/or variability comparison -for FDA and SCABEL for EMA- is preferred due to number of subjects that would be needed.

when pop/indv BE is feasible or applicable? does the nature of the drug molecule determine such approach? also any published BE studies based on either of them.

Thanks in advance.

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,779 posts in 4,000 threads, 1,255 registered users;
online 9 (0 registered, 9 guests [including 8 identified bots]).

I have stopped reading Stephen King novels.
Now I just read C code instead.    Richard A. O'Keefe

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed