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...

clomipramine is a tricyclic antidepressant. different methods for determination of clomipramine hydrochloride in plasma have been described. most of these procedures favor the use of acidic back-extraction in extraction procedure and hplc as the analytical technique. in this study, the clomipramine extraction procedure was modified and a direct injection to the column was performed to shorten t...

a rapid, sensitive and reproducible hplc method using amperometric detector was developed and validated for the analysis of clarithromycin in human plasma. the separation was achieved on a monolithic silica column (mz- c8 125×4.0 mm) using acetonitrile- methanol-potassium dihydrogen phosphate buffer (40:6:54,v/v), with ph of 7.5, as the mobile phase at a flow rate of 1.5 ml/min. the assay enabl...

The bioavailability and bioequivalency of oral drug depends on gastrointestinal tract physiology and drugrelated physicochemical and pharmacokinetic factors. In general, bioavailability of a new drug substance or new formulation is studied in vivo with healthy volunteers. In vivo bioequivalency studies are needed for generic drug products or if a formulation is significantly altered during clin...