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      • KCI등재

        Prediction of metabolizing enzyme-mediated linical drug interactions using in vitro information

        Suein Choi,Dong-SeokYim,Soo Hyeon Bae 대한임상약리학회 2022 Translational and Clinical Pharmacology Vol.30 No.1

        Evaluation of drug interactions is an essential step in the new drug development process. Regulatory agencies, including U.S. Food and Drug Administrations and European MedicinesAgency, have been published documents containing guidelines to evaluate potential druginteractions. Here, we have streamlined in vitro experiments to assess metabolizing enzyme-mediated drug interactions and provided an overview of the overall process to evaluatepotential clinical drug interactions using in vitro data. An experimental approach is presentedwhen an investigational drug (ID) is either a victim or a perpetrator, respectively, and thegeneral procedure to obtain in vitro drug interaction parameters is also described. With the invitro inhibitory and/or inductive parameters of the ID, basic, static, and/or dynamic modelswere used to evaluate potential clinical drug interactions. In addition to basic and static models which assume the most conservative conditions, such as the concentration of perpetratorsas Cmax, dynamic models including physiologically-based pharmacokinetic models take intoaccount changes in in vivo concentrations and metabolizing enzyme levels over time.

      • KCI등재

        An experience on the model-based evaluation of pharmacokinetic drug-drug interaction for a long half-life drug

        Yunjung Hong,Sangil Jeon,Suein Choi,Sungpil Han,Maria Park,Seunghoon Han 대한생리학회-대한약리학회 2021 The Korean Journal of Physiology & Pharmacology Vol.25 No.6

        Fixed-dose combinations development requires pharmacokinetic drugdrug interaction (DDI) studies between active ingredients. For some drugs, pharmacokinetic properties such as long half-life or delayed distribution, make it difficult to conduct such clinical trials and to estimate the exact magnitude of DDI. In this study, the conventional (non-compartmental analysis and bioequivalence [BE]) and modelbased analyses were compared for their performance to evaluate DDI using amlodipine as an example. Raw data without DDI or simulated data using pharmacokinetic models were compared to the data obtained after concomitant administration. Regardless of the methodology, all the results fell within the classical BE limit. It was shown that the model-based approach may be valid as the conventional approach and reduce the possibility of DDI overestimation. Several advantages (i.e., quantitative changes in parameters and precision of confidence interval) of the model-based approach were demonstrated, and possible application methods were proposed. Therefore, it is expected that the model-based analysis is appropriately utilized according to the situation and purpose.

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