Abstract #301178

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JSM 2003 Abstract #301178
Activity Number: 211
Type: Contributed
Date/Time: Tuesday, August 5, 2003 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #301178
Title: Using Nonlinear Mixed Models for Pediatric PK Studies
Author(s): Alan H. Hartford*+ and Arturo Porras and Elizabeth Migoya and Ji Zhang
Companies: North Carolina State University and Merck Research Laboratories and Merck Research Laboratories and Merck Research Laboratories
Address: RY33-404, Rahway, NJ, 07065-0900,
Keywords: pharmacokinetics ; nonlinear mixed models ; pediatric studies
Abstract:

Dosing recommendations for pediatric patients are needed. To aid in this effort, a pharmacokinetic (PK) clinical trial can be conducted. This type of study involves many statistical design challenges for modeling the PK endpoints. These challenges include performing a nonlinear mixed model analysis on few plasma samples per patient. Different methods to analyze these data exist and the Food and Drug Administration and the sponsor may not use the same approach. In particular, differences may be model assumptions, software considerations, convergence of algorithms and presentation of central tendency. These differences will be presented with a case study for Singulair(TM); which was recently approved for the prophylaxis and chronic treatment of asthma in pediatric patients 12 months of age and older. Recommendations for future pediatric studies will be provided.

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