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

Dear Winnie, Allometric size adjustments, provide mechanistic, physiologically based approach. 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 development of models in pediatrics, design and validation of limited sampling strategies in pediatric PK studies, and the integration of historical priors (adult and pediatric data) into pediatric POPPK and clinical trial simulation (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: [EMAIL PROTECTED] > To: [EMAIL PROTECTED] > CC: [email protected] > Subject: Re: [NMusers] Re: [NMUSERS] Questions on fitting pediatric PK data > 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: [EMAIL PROTECTED] _________________________________________________________________ Test your Star IQ http://club.live.com/red_carpet_reveal.aspx?icid=redcarpet_HMTAGMAR