[Should the pharmaceutical industry play an active part in pharmacosurveillance? (author's transl)].
The development of new drugs by pharmaceutical firms proceeds through different phases, i. e. pre-clinical studies and stage I, II and III clinical studies, which normally result in authorization to market. Once the drug is on the market, however, further research work is required to perfect its use and complete our knowledge of it. Stage IV clinical trials, which may be termed "pharmacosurveillance", fall as much as the previous ones within the responsibilities of the pharmaceutical industry, since reports on side-effects are collected and these may have practical applications. Thus, clinical research may be shifted towards possible new indications, or new pharmacological studies may be undertaken to elucidate the mechanism of some side-effects, develop them if they are beneficial, or find a way of preventing them if they are indesirable. With these considerations in mind, the authors have developed a protocol of pharmacosurveillance aimed at determining, through a preliminary in vitro study, the origin of some adverse reactions of anaesthetic drugs. Depending on the results of these studies, clinical applications are considered.
D000777:Anesthetics / Q000009:adverse effects; D000818:Animals; D001491:Basophils / Q000166:cytology; D002986:Clinical Trials as Topic / Q000379:methods*; D003165:Complement System Proteins / Q000032:analysis; D004341:Drug Evaluation; D004353:Drug Evaluation, Preclinical / Q000379:methods; D004342:Drug Hypersensitivity / Q000209:etiology; D004345:Drug Industry; D006801:Humans; D007958:Leukocyte Count / Q000187:drug effects
D000777:Anesthetics; D003165:Complement System Proteins
L'industrie du médicament a-t-elle une vocation de pharmacovigilance?