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European Heart Journal Advance Access originally published online on March 11, 2005
European Heart Journal 2005 26(9):858-860; doi:10.1093/eurheartj/ehi219
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© The European Society of Cardiology 2005. All rights reserved. For Permissions, please e-mail: journals.permissions@oupjournals.org

Substandard life-saving drugs: a global concern

Felicita Andreotti* and Filippo Crea

Institute of Cardiology, Department of Cardiovascular Medicine, Catholic University, Largo F. Vito 1, 00168 Rome, Italy

* Corresponding author. Tel: +39 6 30154187; fax: +39 6 3055535. E-mail address: felicita.andreotti@iol.it

This editorial refers to ‘Comparative analysis of the activity and content of different streptokinase preparations’{dagger} by P. Hermentin et al., on page 933

The first 10% of the full text of this article appears below.

How can consumers and health professionals be sure that the drugs they use are safe and effective? A drug that has been approved for clinical use has undergone thorough evaluation during ‘phase I’ studies (pre-clinical and dose-finding) and during ‘phase II’ and ‘phase III’ randomized trials that test defined regimens of the new drug against a reference treatment in medium and large patient-year groups. This well-codified process provides information on the short- and mid-term safety and efficacy of the drug and forms the basis for approval by regulatory authorities. However, once the medication reaches the open market, it is more difficult to carry out a systematic and long-term evaluation. In this phase (‘phase IV’), pharmaceutical assessment relies on a combination of government-sponsored vigilance, spontaneous reports, and epidemiological monitoring.

The sensational withdrawal of rofecoxib (dictated by . . . [Full Text of this Article]


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Related articles in EHJ:

Comparative analysis of the activity and content of different streptokinase preparations
Peter Hermentin, Thomas Cuesta-Linker, Joerg Weisse, Karl-Heinz Schmidt, Marion Knorst, Michael Scheld, and Michael Thimme
EHJ 2005 26: 933-940. [Abstract] [Full Text]