Points-to-consider documents

Scientific information on the evaluation of genetic polymorphisms during non-clinical studies and phase I clinical trials in the Japanese population

Masahiro Hiratsuka, Noriyasu Hirasawa, Yoshiteru Oshima, Susumu Kodama, Toshio Miyata, Takashi Dan, Hiroyuki Takatoku, Hideaki Kuribayashi, Ryosuke Nakamura, Yoshiro Saito

Research output: Contribution to journalArticle

Abstract

Pharmacotherapy shows striking individual differences in pharmacokinetics and pharmacodynamics, involving drug efficacy and adverse reactions. Recent genetic research has revealed that genetic polymorphisms are important intrinsic factors for these inter-individual differences. This pharmacogenomic information could help develop safer and more effective precision pharmacotherapies and thus, regulatory guidance/guidelines were developed in this area, especially in the EU and US. The Project for the Promotion of Progressive Medicine, Medical Devices, and Regenerative Medicine by the Ministry of Health, Labour and Welfare, performed by Tohoku University, reported scientific information on the evaluation of genetic polymorphisms, mainly on drug metabolizing enzymes and transporters, during non-clinical studies and phase I clinical trials in Japanese subjects/patients. We anticipate that this paper will be helpful in drug development for the regulatory usage of pharmacogenomic information, most notably pharmacokinetics.

Original languageEnglish
JournalDrug Metabolism and Pharmacokinetics
DOIs
Publication statusAccepted/In press - Jan 1 2018

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Clinical Trials, Phase I
Pharmacogenetics
Genetic Polymorphisms
Individuality
Pharmacokinetics
Drug Therapy
Genetic Research
Intrinsic Factor
Regenerative Medicine
Drug-Related Side Effects and Adverse Reactions
Pharmaceutical Preparations
Population
Medicine
Guidelines
Equipment and Supplies
Health
Enzymes

Keywords

  • Genetic polymorphism
  • Non-clinical study
  • Pharmacogenomics
  • Phase I clinical trial
  • Precision pharmacotherapy

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science
  • Pharmacology (medical)

Cite this

Points-to-consider documents : Scientific information on the evaluation of genetic polymorphisms during non-clinical studies and phase I clinical trials in the Japanese population. / Hiratsuka, Masahiro; Hirasawa, Noriyasu; Oshima, Yoshiteru; Kodama, Susumu; Miyata, Toshio; Dan, Takashi; Takatoku, Hiroyuki; Kuribayashi, Hideaki; Nakamura, Ryosuke; Saito, Yoshiro.

In: Drug Metabolism and Pharmacokinetics, 01.01.2018.

Research output: Contribution to journalArticle

Hiratsuka, Masahiro ; Hirasawa, Noriyasu ; Oshima, Yoshiteru ; Kodama, Susumu ; Miyata, Toshio ; Dan, Takashi ; Takatoku, Hiroyuki ; Kuribayashi, Hideaki ; Nakamura, Ryosuke ; Saito, Yoshiro. / Points-to-consider documents : Scientific information on the evaluation of genetic polymorphisms during non-clinical studies and phase I clinical trials in the Japanese population. In: Drug Metabolism and Pharmacokinetics. 2018.
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AU - Kodama, Susumu

AU - Miyata, Toshio

AU - Dan, Takashi

AU - Takatoku, Hiroyuki

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