THE APPLICATION OF NEW BIOAVAILABILITY PARAMETERS IN THE BIOEQUIVALENCE TESTING OF ANTIMICROBIAL AGENTS

Two new bioavailability parameters were recently suggested [Koeleman e t al. 1991] to define (i) the time that the concentration in the blood stays above a defined minimum effective concentration, te and (ii) th e onset of the effect, to. In addition to conventional bioequivalence parameters, the new bioavailability parameters (to and te) were calcul ated in this study and statistically compared for penicillin, chloroqu ine, oxytetracycline, amoxycillin and flucloxacillin from available bi oequivalence data. For oxytetracycline, flucloxacillin and amoxycillin , the conventional bioavailability parameters indicated partial equiva lence whereas using the te and to parameters, more realistic indicatio ns of the possible extent of the performance of a drug from dosage for ms were obtained than with the conventional bioequivalence parameters. The new parameters gave additional information for a better evaluatio n of the performance of a drug from a dosage form.