臨床薬理
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
特集/市販後に分かる薬の安全性と最近の撤退薬
1.薬の安全性の評価~治験から市販後の調査まで~
高橋 春男
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ジャーナル フリー

2009 年 40 巻 1 号 p. 2-6

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The usefulness of new drugs is evaluated by its benefit-risk assessment at the time of approval. To ensure the drug safety, the risk management plan should be consistently monitored from drug development to postmarketing stage. Many drugs have been withdrawn from the market or distribution restricted as a result of spontaneous reports of serious adverse reactions andor drug interactions. In recent years, several drugs have been withdrawn from the market or distribution restricted due to safety reasons based on postmarketing clinical trials. The implementation of a pharmacovigilance plan and risk minimization activities corresponding to the drug's characteristics is significant for the life cycle management of new drugs, as well as other old drugs.

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© 2009 日本臨床薬理学会
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