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KMID : 0370220190630030121
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Yakhak Hoeji
2019 Volume.63 No. 3 p.121 ~ p.130
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The Role Change of Drug Metabolism and Pharmacokinetics Research in the Drug Development
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Kang Won-Ho
Hwang Jin-Ah
Chae Jung-Woo
Kwon Kwang-II
Yun Hwi-Yeol
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Abstract
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Global big pharmaceutical companies identify Absorption-Distribution-Metabolism-Excretion-Toxicity (ADMET) properties in early drug discovery stage to improve poor pharmacokinetics (PK) and bioavailability (BA) that are the major cause of attrition rate in drug development in 1990s. Attrition rate due to poor PK and BA was around 40% among total attrition rate. Hence, they intend to assign in-vitro ADME assay evaluations at the early drug discovery stage for finding optimal ADME chemicals to reduce attrition rate. As a result, attrition rate in 2000s due to poor PK & BA greatly decreased to less than 8% and the role of Drug-Metabolism and Pharmacokinetics (DMPK) research has changed importantly during this process. According to this trend, canonical role of DMPK is moving fast to convergence area for optimization of new drugs. We expressed typical nonclinical work-flow in the 1990s and 2000s and tried to investigate how non-clinical work-flow changed in early drug discovery stage. The biggest changes are that in-vitro ADME assays were performed during the early drug discovery stage. In this review, we tried to inform to Korean pharmaceutical company about the world wide paradigm shift in DMPK research. We discussed drug discovery strategies to increase the success rate and the future direction of DMPK research scope.
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KEYWORD
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Non-clinical work-flow, paradigm shift, DMPK research scope
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