Model‐based approach to sampling optimization in studies of antibacterial drugs for infants and young children

Autor:	Naomi Nagai, Akira Okada, Makoto Kakara, Yuji Orito
Rok vydání:	2021
Předmět:	030213 general clinical medicine medicine.medical_specialty Cefepime RM1-950 Models Biological 030226 pharmacology & pharmacy Article General Biochemistry Genetics and Molecular Biology 03 medical and health sciences Bayes' theorem 0302 clinical medicine Drug Development Japan Ciprofloxacin Humans Medicine Computer Simulation Sampling optimization General Pharmacology Toxicology and Pharmaceutics Intensive care medicine Blood Specimen Collection business.industry Research General Neuroscience Clinical study design Infant Sampling (statistics) Bayes Theorem Articles General Medicine Anti-Bacterial Agents Clinical trial Drug development Child Preschool Therapeutics. Pharmacology Public aspects of medicine RA1-1270 business medicine.drug Pediatric population
Zdroj:	Clinical and Translational Science Clinical and Translational Science, Vol 14, Iss 4, Pp 1543-1553 (2021)
ISSN:	1752-8062 1752-8054
DOI:	10.1111/cts.13018
Popis:	Clinical trials for pediatric indications and new pediatric drugs face challenges, including the limited blood volume due to the patients’ small bodies. In Japan, the Evaluation Committee on Unapproved or Off‐labeled Drugs with High Medical Needs has discussed the necessity of pediatric indications against the background of a lack of Japanese pediatric data. The limited treatment options regarding antibiotics for pediatric patients are associated with the emergence of antibiotic‐resistant bacteria. Regulatory guidelines promote the use of model‐based drug development to reduce practical and ethical constraints for pediatric patients. Sampling optimization is one of the key study designs for pediatric drug development. In this simulation study, we evaluated the precision of the empirical Bayes estimates of pharmacokinetic (PK) parameters based on the sampling times optimized by published pediatric population PK models. We selected three previous PK studies of cefepime and ciprofloxacin in infants and young children as paradigms. The number of sampling times was reduced from original full sampling times to two to four sampling times based on the Fisher information matrix. We observed that the precision of empirical Bayes estimates of the key PK parameters and the predicted efficacy based on the reduced sampling times were generally comparable to those based on the original full sampling times. The model‐based approach to sampling optimization provided a maximization of PK information with a minimum burden on infants and young children for the future development of pediatric drugs.
Databáze:	OpenAIRE
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