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薬理と治療
Abstract
[The modeling and simulation(M & S)approach based on population pharmacokinetic/pharmacodynamic(PK/PD)analysis has recently been used in drug development in the European and American pharmaceutical industries to assure the quality and efficiency of clinical trials. Unfortunately, the M & S approach is not popular in the Japanese pharmaceutical industry. In this article, we firstly introduce the background and characterization of pharmacometrics, which is a collective term for M & S including non−compartmental PK analysis, exposure−response analysis, compartmental PK analysis and PK/PD analysis. This explanation includes a history of PK and PK/PD and the Challenge and Opportunity on the Critical Path to New Medical Products announced by the U. S. Food and Drug Administration. Then, we examine 17 examples of published M & S approaches and group them by development stage and pharmacometric method. The appropriate approach for each stage of drug development is recommended based on our investigations. We extracted four examples from the 17, and used the M & S approaches in these four examples in each phase of drug development, namely Phase 1, Phase 2, Phase 3 and Phase 4. In particular, we describe the impact of each on drug development and their features. Development of pharmacometrician resources, improvement of the analytical system environment and integration of the M & S approach in drug development organization control are essential to the expansion and prosperity of the Japanese pharmaceutical industry by popularization of the M & S approach.(Jpn Pharmacol Ther 2008;36:277−84)KEY WORDS Population pharmacokinetics and pharmacodynamics, Pharmacometrics,Modeling and Simulation, Clinical development, The modeling and simulation(M & S)approach based on population pharmacokinetic/pharmacodynamic(PK/PD)analysis has recently been used in drug development in the European and American pharmaceutical industries to assure the quality and efficiency of clinical trials. Unfortunately, the M & S approach is not popular in the Japanese pharmaceutical industry. In this article, we firstly introduce the background and characterization of pharmacometrics, which is a collective term for M & S including non−compartmental PK analysis, exposure−response analysis, compartmental PK analysis and PK/PD analysis. This explanation includes a history of PK and PK/PD and the Challenge and Opportunity on the Critical Path to New Medical Products announced by the U. S. Food and Drug Administration. Then, we examine 17 examples of published M & S approaches and group them by development stage and pharmacometric method. The appropriate approach for each stage of drug development is recommended based on our investigations. We extracted four examples from the 17, and used the M & S approaches in these four examples in each phase of drug development, namely Phase 1, Phase 2, Phase 3 and Phase 4. In particular, we describe the impact of each on drug development and their features. Development of pharmacometrician resources, improvement of the analytical system environment and integration of the M & S approach in drug development organization control are essential to the expansion and prosperity of the Japanese pharmaceutical industry by popularization of the M & S approach.(Jpn Pharmacol Ther 2008;36:277−84)KEY WORDS Population pharmacokinetics and pharmacodynamics, Pharmacometrics,Modeling and Simulation, Clinical development]
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