From: Tata, Prasad N Prasad.Tata@TycoHealthcare.com
Subject: [NMusers] POP PK study in pediatrics
Date: Tue, June 1, 2004 10:54 am
Dear All:
I appreciate if someone can guide me towards a good pediatric study design for
pharmacokinetics study using sparse sampling (one or two blood draws per subject).
The agent I am interested to study is a radioactive compound and the subjects are housed
for 24 hrs. I am facing a dilemma of exploring limited samples per subject and yet to
characterize complete PK in pediatric patients.
Any help is highly appreciated.
Prasad
Prasad NV Tata, M.Pharm., Ph.D.
Manager-Pharmacokinetics
Mallinckrodt, Inc.
675 McDonnell Blvd.
Saint Louis, MO 63134-5840
Tel: (314) 654-5325
Fax: (314) 654-9325
e-mail: prasad.tata@tycohealthcare.com
POP PK study in pediatrics
From: Bhattaram, Atul BhattaramA@cder.fda.gov
Subject: RE:[NMusers] POP PK study in pediatrics
Date: Tue, June 1, 2004 11:24 am
Hello Tata
It depends on the prior information you have on your compound. You could do simulations and evaluate various scenarios.
Venkatesh Atul Bhattaram
Pharmacometrics
DPE-1, OCPB
CDER, FDA.
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