PK model parameters IR vs MR [PK / PD]

posted by ElMaestro  – Belgium?, 2019-09-03 17:43 (454 d 03:45 ago) – Posting: # 20535
Views: 2,099

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,

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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