Bioequivalence and Bioavailability Forum • PK model parameters IR vs MR

PK model parameters IR vs MR [PK / PD]

posted by ElMaestro – Belgium?, 2019-09-03 17:43 (344 d 22:14 ago) – Posting: # 20535
Views: 1,840

Hi mittyri,

» recently I got a question from my colleague and I didn't find good answer. Maybe you can help.
» Suppose there's a data from MD study for IR formulation and the model built is good enough for the data description.
» Now you get another dataset (SD) with the same analyte but MR formulation. Trying to build the model you figure out that the parameters differ significantly (both Cl and V).
» What could be a reason of that observation?

You have a difference in the absorbed fraction from the two formulations which screws everything up.

» We know that the kidneys do not care about lineage of entity.

What is meant with this term??

—
I could be wrong, but...

Best regards,
ElMaestro

"Pass or fail" (D. Potvin et al., 2008)

Complete thread:

PK model parameters IR vs MR mittyri 2019-09-02 22:15 [PK / PD]
- PK model parameters IR vs MR jag009 2019-09-03 16:07
  - PK model parameters IR vs MR mittyri 2019-09-03 16:54
- PK model parameters IR vs MRElMaestro 2019-09-03 17:43
  - PK model parameters IR vs MR mittyri 2019-09-03 18:05
- Parameter-identifiability? Helmut 2019-09-07 13:03
  - transit compartments... mittyri 2019-09-07 22:25
    - No organs in (Pop)PK Helmut 2019-09-08 10:56