a sensitive and rapid method is described for determination of clopidogrel carboxylic acid (cca), the inactive metabolite of the antiplatelet agent clopidogrel in human serum. the analytical procedure involves liquid-liquid extraction of the analyte and an internal standard (phenytoin) with ethyl acetate. a mobile phase consisting of 0.05 m phosphate buffer containing triethylamine (0.5 ml/l; p...

a bioequivalence study of two verapamil formulations (generic verapamil tablets and isoptin® tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. moreover, the feasibili...

        A sensitive and rapid method is described for determination of clopidogrel carboxylic acid (CCA), the inactive metabolite of the antiplatelet agent clopidogrel in human serum. The analytical procedure involves liquid-liquid extraction of the analyte and an internal standard (phenytoin) with ethyl acetate. A mobile phase consisting of 0.05 M phosphate buffer containing triethylamine (0.5...

A bioequivalence study of two verapamil formulations (generic verapamil tablets and Isoptin® tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. Moreover, the feasibili...

a rapid and sensitive liquid chromatography–tandem mass spectrometry (lc-ms) method for the estimation of enalapril and enalaprilat in human plasma. detection of analytes was achieved by tandem mass spectrometry with electrospray ionization (esi) interface in positive ion mode was operated under the multiple-reaction monitoring mode. sample pretreatment involved in a one-step protein precipitat...

A bioequivalence study of two verapamil formulations (generic verapamil tablets and Isoptin® tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. Moreover, the feasibili...

Two drug products are considered bioequivalent 'if their bio-availabilities ... are similar to such a degree that their effects, with respect to both efficacy and safety, will essentially be the same'. 1 The bioequivalence of two drug products is generally demonstrated through a clinical study in healthy volunteers, the so-called bioequivalence study. If bioequivalence is shown for two drug pro...

The purpose of this study was to determine if different methods for average bioequivalence in high variability drugs coincide or not in their conclusions when applied to the same dataset, and to discuss the method validity and reliability of the conclusions. Different approaches for the evaluation of average bioequivalence were applied to the results of a bioavailability trial on the diuretic d...

The purpose of this article is to explicate the procedures for detecting outliers subject in bioequivalence study as per as per various regulatory agencies (e.g. USFDA, TPD, ANVISA and CDSCO). The existence of outlier subjects in bioequivalence studies possibly will have an effect on the results of the study. The present article provides the details regarding Studentized Residual Test and Lund ...

PROLOGUE This lecture material is covered in one and one-half fiftyminute lecture periods. The primary objectives of the lecture are to: (i) review interpatient and intrapatient pharmacokinetic variability; (ii) introduce the concepts of therapeutic equivalence and bioequivalence; (iii) introduce the current FDA standards on bioequivalence; (iv) introduce the basic approach of bioequivalency te...