Collins, P.

Iorio, A.

Lillicrap, D.

Makris, M.

Peyvandi, F.

Pipe, S.W.

Rosendaal, F.R.

Subcomm Factor VIII Factor IX

Journal of Thrombosis and Haemostasis

English

F. Peyvandi

M. Makris

P. Collins

D. Lillicrap

S.W. Pipe

A. Iorio

F.R. Rosendaal

Crossref

Minimal dataset for post‐registration surveillance of new drugs in hemophilia: communication from the SSC of the ISTH

Leiden University Scholary Publications

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

Pipe, S. W.

Rosendaal, F. R.

AIR Universita degli studi di Milano

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]

Peyvandi, F

Makris, M

Collins, Peter

Lillicrap, D

Iorio, A

Online Research @ Cardiff

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

https://air.unimi.it/retrieve/handle/2434/557266/1088242/MinimalDataset_for_post_registration_surveillancePrePrint.pdf

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

Abstract

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Crossref

Leiden University Scholary Publications

AIR Universita degli studi di Milano

Online Research @ Cardiff