RE: [NMusers] Re: [NMUSERS] Questions on fitting pediatric PK data using NONMEM

Dear Winnie,
Allometric size adjustments, provide mechanistic, physiologically based app=
roach. They permit delineation of the effect of size from that of
other covariates that show a high degree of collinearity. Meibohm et al The=
 AAPS Journal 2005, 7, E475-E487; discussed 3 issues that are particularly=
 important in pediatric studies like body-size adjustments during the devel=
opment of models in pediatrics, design and validation of limited sampling s=
trategies in pediatric PK studies, and the integration of historical prior=
s (adult and pediatric data) into pediatric POPPK and clinical trial simula=
tion (CTS) models.

Regards, Krishna
___________________

Krishna Devarakonda. MPharm, PhD

Covidien Inc.,

675 McDonnell Blvd.

Hazelwood

63042 Missouri,

(314)654 3364 (Work)

(314)277 5214 (Cell)


> Date: Wed, 26 Mar 2008 11:39:40 +0100
> From: hempege_at_uni-muenster.de
> To: winnie.seto_at_sickkids.ca
> CC: nmusers_at_globomaxnm.com
> Subject: Re: [NMusers] Re: [NMUSERS] Questions on fitting pediatric PK da=
ta using NONMEM
>
> Dear Winnie,
>
> it is not advisable to "normalize" the data to body weight or body
> surface area.
> Instead, you should build a basic model without weight/BSA and try to
> use weight or BSA as covariate for the pharmacokinetic parameters. Also,=
 
> you should test the allometric scaling approach (see Anderson et al.
> Clin Pharmacokin 33(5): 313-327 (1997).
>
> With best regards
>
> Georg
>
> --
> Hochschuldozent Dr. Georg Hempel
> Institut fuer Pharmazeutische und Medizinische Chemie
> - Klinische Pharmazie -
> Hittorfstr. 58-62
> 48149 Muenster, Germany
> E-mail: georg.hempel_at_uni-muenster.de

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Received on Wed Mar 26 2008 - 07:37:15 EDT