Pharmacometrics in children

[Speaker] Tsuyoshi Fukuda:1,2
1:Cincinnati Children's Hospital Medical Center, USA, 2:Department of Pediatrics, University of Cincinnati College of Medicine, USA

 Growth and development are integral components of pediatric clinical pharmacology which can be used to assist the characterization of the PK/PD relationships of drugs in pediatric patients. Well-characterized PK/PD parameters can be utilized to define standard therapeutic dosing regimens over a wide range of ages.
 Integrating pharmacometric methodology into pediatric studies has been increasingly recognized as an important approach for incorporating the concept of growth and development in the model analysis. Several challenges are associated with pediatric studies which include: the relatively small number of patients, sparse sampling, a wide age range, and potential differences in disease status associated with age. The methodology can also assist in addressing the challenge of filling in data gaps. Thus, pharmacometrics has helped us analyze limited pediatric data by utilizing available drug and/or physiological information, provide additional knowledge regarding the PK/PD profiles for the population or an individual, and even design new effective pediatric studies. The long-standing recognition of these benefits, supported by many researchers, accelerate the use of pharmacometric approaches not only in clinical settings for individualized dosing in pediatric patients, but also in pediatric drug development. These approaches include: population PK/PD analysis, which describes typical PK-PD profiles and population variability; PBPK technique, which provides a mechanistic understanding of influencing factors to the profiles; and Bayesian adaptive control methodology, which adjusts the dose based on observations against individual variability.
 My presentation will focus on growth and development as it relates to pediatric data analysis and interpretation. I will also discuss how we at Cincinnati Children's Hospital utilize population PK/PD analyses, PBPK model-based analyses, and Bayesian adaptive control methodology for clinical studies and clinical practice in our pediatric patient population.

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