PK model parameters IR vs MR [PK / PD]

posted by mittyri – Russia, 2019-09-02 22:15  – Posting: # 20531
Views: 373

Dear All!

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

Kind regards,
Mittyri

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,818 posts in 4,201 threads, 1,361 registered users;
online 8 (0 registered, 8 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 18:20 CEST

If I find 10,000 ways something won’t work, I haven’t failed.
I am not discouraged, because every wrong attempt discarded
is another step forward.    Thomas Alva Edison

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