The Japanese Postmarketing Adverse Event Relief System: A Confluence of Regulatory Science, the Legal System, and Clinical Pharmacology
| Autor: | Yukio Oniyama, Ariel D. Weber, Tatsuya Kondo, Toshiyoshi Tominaga, Seiko Miyazaki |
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| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Postmarketing surveillance Pharmacology 030226 pharmacology & pharmacy Risk Assessment System a law.invention 03 medical and health sciences 0302 clinical medicine Japan law medicine Product Surveillance Postmarketing Adverse Drug Reaction Reporting Systems Humans Pharmacology (medical) Regulatory science Intensive care medicine Adverse effect Drug Labeling Clinical pharmacology business.industry medicine.disease Causality 030220 oncology & carcinogenesis Compensation and Redress Pharmacology Clinical business Adverse drug reaction Healthcare system |
| Zdroj: | Clinical pharmacology and therapeutics. 102(2) |
| ISSN: | 1532-6535 |
| Popis: | The Japanese Postmarketing Relief System provides for compensation to patients with adverse reactions, based on the acknowledgment that unpredicted adverse events occur inevitably once a drug is marketed. The system also provides new knowledge about the benefit-risk profile of a drug that may be incorporated into product labeling. The system relies on causality assessments that are based on sound clinical pharmacology principles. The system may serve as a model for other countries' healthcare systems. |
| Databáze: | OpenAIRE |
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