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 |
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| Affiliation: | 1. Graduate School of Pharmaceutical Sciences, Tohoku University, Sendai, Japan;2. Graduate School of Medicine, Tohoku University, Sendai, Japan;3. Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan;4. National Institute of Health Sciences (NIHS), Tokyo, Japan;5. Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan;1. Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA;2. Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA;1. Department of Pathology II, Kansai Medical University, 2-5-1 Shin-machi, Hirakata, Osaka 573-1010, Japan;2. Division of Diagnostic Cytopathology and Histopathology, Kansai Medical University Medical Center, Fumizono 10-15, Moriguchi, Osaka 570-8507, Japan;3. Cellular & Molecular Pathology Branch, National Institute of Environmental Health Sciences, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709, USA;1. Department of Biochemistry and Medical Genetics, School of Health Sciences, Medical University of Silesia, Katowice, Poland;2. Department of Neuropediatrics, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland;3. Department of Developmental Neurology, Medical University of Gdansk, Gdansk, Poland;4. Department of Pediatric and Adolescent Neurology, Jagiellonian University Medical College, Kraków, Poland;6. Department of Neurology, Polish Mother''s Memorial Hospital- Research Institute, Łódź, Poland;1. Department of Radiation Oncology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Republic of Korea;2. Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Republic of Korea;3. Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Republic of Korea;4. Department of Radiation Oncology, Seoul National University Hospital, Seoul, Republic of Korea;5. Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea;7. Department of Radiation Oncology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea;11. Department of Obstetrics and Gynecology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea;12. Department of Radiation Oncology, Cheil General Hospital and Women''s Healthcare Center, Kwandong University, College of Medicine, Seoul, Republic of Korea;8. Department of Obstetrics and Gynecology, Cheil General Hospital and Women''s Healthcare Center, Kwandong University, College of Medicine, Seoul, Republic of Korea;9. Department of Obstetrics and Gynecology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Jeollanam-do, Republic of Korea;71. Department of Radiation Oncology, Korea University Ansan Hospital, Ansan, Republic of Korea;112. Department of Obstetrics and Gynecology, Korea University Ansan Hospital, Ansan, Republic of Korea;123. Department of Radiation Oncology, Chung-Ang University Hospital, Seoul, Republic of Korea;84. Center for Uterine Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea;1. Department of Radiation Oncology and Molecular Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland;2. Department of Statistics, Stanford University, Palo Alto, California |
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| 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. |
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| Keywords: | Genetic polymorphism Pharmacogenomics Non-clinical study Phase I clinical trial Precision pharmacotherapy |
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