Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (7): 721-727.
DOI: 10.19803/j.1672-8629.2022.07.06

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Advances in pediatric drug for central sedation based on pharmacokinetic/pharmacodynamic modeling and simulation

ZHU Jinying1,2, ZHOU Sufeng1, WANG Lu1, XU Mingzhe3#, SHAO Feng1,2,*   

  1. 1Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing Jiangsu 210029, China;
    2School of Pharmacy, Nanjing Medical University, Nanjing Jiangsu 211166, China;
    3National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2022-01-14 Online:2022-07-15 Published:2022-07-12

Abstract: Objective To summarize the pharmacokinetic/pharmacodynamic (PK/PD) models of central sedative pediatric drugs in order to provide references for quantitative pharmacological models in pediatric drug research and development. Methods The related literature of quantitative pharmacology of central sedative pediatric drugs were collected, analyzed, and summarized in the recent 20 years. Results Clearance was a key parameter to fit the PK/PD models, so it could be critical for determining the doses for pediatrics at different ages. Moreover, there was also a good correlation between the clearance and body weight in pediatric population. Conclusion A close attention should be paid on the physiological characteristics of pediatric patients, especially for investigating drugs acting on the central nervous system. Based on the physiological pharmacokinetic differences and drug exposure-response differences between pediatrics and adults, and considering the practice points of pediatric clinical trials, the PK/PD model supports the pediatric individualized treatment with central sedation drugs.

Key words: pediatric population, pharmacokinetic/pharmacodynamic model, data extrapolation, central sedation, dose regimen, individualized treatment

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