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Minimal dataset for post-registration surveillance of new drugs in haemophilia: communication from the SSC or the ISTH

Peyvandi, F, Makris, M, Collins, Peter, Lillicrap, D, Pipe, S.W., Iorio, A and Rosendaal, F.R. 2017. Minimal dataset for post-registration surveillance of new drugs in haemophilia: communication from the SSC or the ISTH. Journal of Thrombosis and Haemostatis 15 (9) , pp. 1878-1881. 10.1111/jth.13762

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Abstract

The term ‘postmarketing surveillance’ refers to analyses for the purpose of detecting adverse drug reactions in data accumulated after a medicinal product has been authorized by a regulatory agency [1-3]. The current regulatory process has systematic provisions for obtaining important data needed to ensure the safety of novel drugs almost exclusively during premarketing testing [4]. However, premarketing trials frequently do not have sufficient power to reliably detect important adverse drug reactions [5].

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: R Medicine > R Medicine (General)
Uncontrolled Keywords: Haemophilia; Factor VIII; Factor IX; replacement products; inhibitors; side effects
Publisher: Wiley-Blackwell
ISSN: 1538-7933
Date of First Compliant Deposit: 29 June 2017
Date of Acceptance: 18 June 2017
Last Modified: 02 Aug 2018 14:26
URI: http://orca.cf.ac.uk/id/eprint/101891

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