Bioequivalence and Bioavailability Forum • Distinguish accumulation

Distinguish accumulation [NCA / SHAM]

posted by oksanachlebko – Ukraine, 2018-01-05 01:10 (2735 d 22:07 ago) – Posting: # 18146
Views: 10,564

Dear Helmut!
I kindly ask you to help me with the following question!

❝ If I get an accumulation index in the MD study more or less different from 1 I try to give additional information, whether the drug shows true nonlinear PK, or only a small shift due to the second compartment.

is it possible to distinguish true nonlinear PK and shift due to other compartments?
What if the dose proportionality is proven but accumulation index is more than 1.4?

All the Best!
Oksana

Complete thread:

half-life in multiple-dosed steady-state BE/BA study? yjlee168 2009-07-14 14:16 [NCA / SHAM]
- half-life in steady state; WinNonlin Helmut 2009-07-15 15:09
  - no lambda(z), no NCA? yjlee168 2009-07-16 11:53
    - NCA without lambda(z) Helmut 2009-07-16 14:06
      - No rule is the rule - lambda(z) of MD BE yjlee168 2009-07-16 22:17
  - Distinguish accumulationoksanachlebko 2018-01-05 00:10