NONMEM Users Network Archive

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RE: Simultaneous vs sequential for modeling parent AND metabolites in pop PK

From: Hussein, Ziad <Ziad.Hussein>
Date: Tue, 9 Dec 2008 16:37:56 -0000

Hi Alan,

I just had a very recent experience few weeks ago for a sequential PopPK
for parent and metabolite that was submitted to the FDA and they came
back and asked for simultaneous modelling.

Whether this is scientific or not the FDA view should be taken into
consideration.

Kind regards,
Ziad

-----Original Message-----
From: owner-nmusers
On Behalf Of Xiao, Alan
Sent: 09 December 2008 16:02
To: nmusers
Subject: [NMusers] Simultaneous vs sequential for modeling parent AND
metabolites in pop PK

Dear All,

I know this is an old topic but would like to see the statistics.

When you have to develop a pop PK model for both parent and active
metabolites, which approach do you prefer or have you used most:
simultaneous or sequential? Which way do you think is more scientific? I
heard comments saying that the simultaneous approach is not scientific.

Thanks,

Alan
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Received on Tue Dec 09 2008 - 11:37:56 EST

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