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KMID : 1142220230180010045
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Regulatory Research on Food, Drug & Cosmetic
2023 Volume.18 No. 1 p.45 ~ p.52
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Trends on Research and Evaluation of Drug Use for Special Population Using Pharmacometrics
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Ha Ji-Hye
Byeon Ji-Young
Lee Chung-Hee
Ahn Mee-Ryung
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Abstract
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Recently, studies using pharmacometric techniques such as modeling and simulation are being actively conducted to generate the evidences for the safe use of medicines in special population, such as children and the elderly, who are relatively vulnerable to adverse effects. Major examples are the population pharmacokinetic analysis to suggest the optimal dosage from a limited number of pharmacokinetic-pharmacodynamic study results and the extrapolation of indication according to comparing differences in drug responses between adults and children even without clinical trials for efficacy, and these methods were applied to some cases of supplemental applications for antibiotics and anticancer drugs. Regulatory agencies including US FDA and Japan PMDA published continually the guidelines related with pharmacometrics, and the ICH is also planning to enact new guidelines or revise existing guidelines based on the ‘model-informed drug development expert group’ activities. In line with this global trend, the Ministry of Food and Drug Safety is also supporting research to establish scientific grounds for the safe use of medicines in vulnerable groups, and plans to continue research and technical support for this.
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KEYWORD
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Pharmacometrics, Modelling & Simulation, Special Population, Physiologically Based-Pharmaco Kinetic model, Population Pharmacokinetics, Extrapolation
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