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Balancing Societal Needs and Regulatory Certainty: The Case Study of Peramivir in Japan.
MedLine Citation:
PMID:  23422872     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.Clinical Pharmacology & Therapeutics (2013); advance online publication 20 February 2013. doi:10.1038/clpt.2012.268.
Authors:
T Tominaga; Y Ando; N Nagai; J Sato; T Kondo
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-15
Journal Detail:
Title:  Clinical pharmacology and therapeutics     Volume:  -     ISSN:  1532-6535     ISO Abbreviation:  Clin. Pharmacol. Ther.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-2-20     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372741     Medline TA:  Clin Pharmacol Ther     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.
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