CZECH MEDICAL ASSOCIATION J. Ev. PURKYNĚ | |
Journals - Article | |
Česky / Czech version | Čas. Lék. čes., 2007, 146, pp. 431–433. |
Bioequivalence Studies of Pharmaceutical
Preparations 1Vetchý D., 2Frýbortová K., 1Rabišková M., 3Daněčková H. 1Ústav technologie léků, Farmaceutická fakulta, Veterinární a farmaceutická univerzita, Brno 2PLIVA – Lachema a.s., Brno 3Státní ústav pro kontrolu léčiv, Praha |
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Summary: Bioequivalence studies are very important for the development of a pharmaceutical preparation in the
pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic
parameters after the administration of tested drugs. The target of such study is to evaluate the therapeutic
compatibility of tested drugs (pharmaceutical equivalents or pharmaceutical alternatives). The
importance of bioequivalence studies is increasing also due to the large growth of the production and
consumption of generic products. Generic products represent approximately 50 % of the whole
consumption in many European countries and USA. The search output of bioequivalence study is
together with the pharmaceutical quality data of medical product one of the main part of the registration
file submitted to a national regulatory authorities. The registration of generic products does not demand
complicated and expensive clinical study contrary to original product. The comparison of the original
and the generic product via bioequivalence study is suggested as sufficient. The aim of this article is to
provide to a medical public a summary about the types of bioequivalence studies, their range, rules of
their practise and let them gain their own attitude to this question.
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