Since the 'thalidomide disaster' in 1961, there is extensive national and intemationallegisiation for the registration and monitoring of drugs. The current drug approval process in most developed countries includes pre-clinical animal testing followed by three phases of clinical testing during which the efficacy and safety of drugs are detennined. Despite this process, however, not all drug effects are known at the moment of marketing approval. For most indications less than 3,000 patients are exposed to a drug during the pre-registration phase. This implies that an adverse reaction can only be detected with 95% certainty if the occurrence is at least 1 per 1,000 patients and the background incidence is zero. After regulatory approval, however, millions of people will use the drug with the possibility that less common unknown adverse drug reactions can emerge. In order to enable continuous reassessment of the benefit/risk ratio of a specific drug in the post-marketing phase, it is necessary to continuously monitor utilisation and effects of drugs after their approval.

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B.H.Ch. Stricker (Bruno) , H.G.M. Leufkens (Hubert)
Erasmus University Rotterdam
The Department of Epidemiology & Biostatistics of the Erasmus Medical Center Rotterdam, the Department of Pharmacoepidemiology & Pharmacotherapy of the Utrecht Institute for Pharmaceutical Sciences, IPCI, Interpharm BV, Brocacef BV, Abbot BV, Astra Zenica BV, Bayer BV, Glaxo Wellcome BV, IMS HEALTH BV, Leo Pharma BV, Pfizer BV, Roche BV, and Wyeth Lederle BV financially supported the printing of this thesis.
Erasmus MC: University Medical Center Rotterdam

van der Linden, P.D. (2001, February 21). Fluoroquinolones and tendon disorders. Erasmus University Rotterdam. Retrieved from