Balancing Societal Needs and Regulatory Certainty: The Case Study of Peramivir in Japan. Issue 4 (15th January 2013)

• Record Type: Journal Article
• Authors: Tominaga, T; Ando, Y; Nagai, N; Sato, J; Kondo, T
• Is Part Of: Clinical pharmacology & therapeutics. Volume 93:Issue 4(2013)
• Page Start: 342
• Page End: 344
• Publication Date: 2013-01-15
• Subjects: Pharmacology -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1038/clpt.2012.268
• Languages: English
• ISSNs: 0009-9236

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <p>Regulators must balance societal and medical requirements against the need for certainty about benefit and risk for new medicines. This is described in a case study of the expedited review and approval of peramivir, a novel neuraminidase inhibitor, in Japan in the context of the emergence of new strain of influenza in 2009. The case illustrates the importance of regulatory science and transparency in supporting such decision making.</p> <p> <italic>Clinical Pharmacology &amp; Therapeutics</italic> (2013); <bold>93</bold> 4, 342–344. doi:<ext-link ext-link-type="doi" xlink:type="simple" xmlns:xlink="http://www.w3.org/1999/xlink">10.1038/clpt.2012.268</ext-link></p> </abstract>