Utilisation of Human Pharmacology Studies with Biomarkers for New Drug Applications in Japan
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Drugs R D 2005; 6 (1): 21-34 1174-5886/05/0001-0021/$34.95/0 © 2005 Adis Data Information BV. All rights reserved.
Utilisation of Human Pharmacology Studies with Biomarkers for New Drug Applications in Japan Yasuo Kodama,1 Kazuyuki Saito,2 Shunsuke Ono,3 Hirofumi Kodama,4 Masae Kuranari,5 Kimiko Tsutsumi,6 Deborah F. Yaplee,7 Hiromi Takano-Ohmuro,7 Mizue Mutoh1 and Akio Fujimura2 1 2 3 4 5 6 7
Laboratory of Bio-Pharmaceutics, Faculty of Pharmaceutical Sciences, Josai International University, Togane, Chiba, Japan Department of Clinical Pharmacology, Division of Clinical Pharmacology, Jichi Medical School, Tochigi, Japan Graduate School of Pharmaceutical Sciences, The University of Kanazawa, Kanazawa, Japan Department of Pharmacy, The University of Miyazaki, Miyazaki, Japan Department of Clinical Pharmacy, The University of Oita, Oita, Japan Department of Clinical Pharmacology and Therapeutics, The University of Oita, Oita, Japan Pharmaceuticals and Medical Devices Evaluation Center, National Institute of Health Sciences, Ministry of Health, Labour and Welfare, Tokyo, Japan
Abstract
Objective: This study evaluated the utilisation of human pharmacology studies with biomarkers for either efficacy or safety estimation conducted for new drug applications (NDAs) submitted to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW). Methods: A total of 50 new chemical entities (NCEs) posted on the Websites, which were approved from June 2000 to November 2001, were evaluated by investigating their approval information. The utilisation of human pharmacology studies with biomarkers was evaluated by focusing on the classification referred to biomarkers for either efficacy or safety estimation and timing of studies. Results: The human pharmacology studies with biomarkers for either efficacy or safety estimation were conducted in 20 compounds classified by utilising measures of either efficacy (17 compounds) or safety (seven compounds). In 4 of 17 NCEs, some of the biomarkers in human pharmacology studies were similar to the clinical endpoints for efficacy assessment in therapeutic exploratory and/or therapeutic confirmatory studies. For safety assessment in therapeutic exploratory and/ or therapeutic confirmatory studies, clinical endpoints rather than biomarkers in human pharmacology studies were used in all seven NCEs. The timing of each type of clinical study could only be obtained for 15 NCEs. Of these 15 NCEs, human pharmacology studies with biomarkers for either efficacy or safety estima-
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tion were conducted on six compounds. There were only two compounds for which human pharmacology studies with biomarkers for efficacy estimation were conducted before pivotal studies such as a therapeutic exploratory study or a bridging study. Conclusion: Our survey suggests that with Japanese NDAs, human pharmacology studies with biomarkers for either efficacy or safety estimation do not play a key role in accelerating drug development and maximising the knowledge gained from confirm
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