Regulatory Science as a Bridge Between Science and Society

descriptionPublicationkeyboard_double_arrow_right Article 01 Jul 2011Publisher:WileyJournal:Clinical Pharmacology & Therapeutics, volume 90, pages 29-31 (issn: 0009-9236, eissn: 1532-6535,

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Authors: T, Tominaga; Y, Asahina; Y, Uyama; T, Kondo;

doi: 10.1038/clpt.2011.89

pmid: 21691273

Regulatory Science as a Bridge Between Science and Society

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Abstract

Development of innovative drugs has recently become more difficult. The case of rosiglitazone shows the extreme difficulty of making the regulatory decision that will best balance the benefits and risks of a drug. There is a high expectation that regulatory science (RS) can improve the situation. However, without user understanding of its basic characteristics, RS will not deliver what is expected.

Related Organizations

Pharmaceuticals and Medical Devices Agency
Japan

Keywords

Databases, Factual, Drug Industry, United States Food and Drug Administration, Decision Making, United States, Europe, Government Agencies, Data Interpretation, Statistical, Pharmacology, Clinical, Humans, Drug Approval

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