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THE ASSESSMENT OF BIOLOGICAL EQUIVALENCE (BIOEQUIVALENCE) OF DRUGS BASED ON THEIR PHARMACODYNAMIC VARIABLES
Medical faculty Priština , Kosovska Mitrovica , Kosovo*
Medical faculty Priština , Kosovska Mitrovica , Kosovo*
Medical faculty Novi Sad , Novi Sad , Serbia
Published: 01.12.2010.
Volume 38, Issue 2 (2010)
pp. 99-102;
Abstract
Biological equality assessments are carried out by means of: a) comparative pharmacokinetic study; b) comparative pharmacodynamic study; c) controlled comparative clinical experimentation; d) comparative in vitro assay (dissolution test). The first method mentioned, i.e. determining the concentration of a drug in the blood of healthy volunteers, is the most accurate and most frequently employed. In this paper, a study conducted on healthy volunteers that displays the possibility of evaluating biological equality using pharmacodynamic variable data, giving the example of such assay of retard tablets of verapamil produced by two different companies, is presented. Taking into account the effects of this drug, biological equivalence was proved by comparing pharmacodynamic variables such as PR interval, systolic and diastolic blood pressure and heart rate.
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