Theoretically, calculating the sample size required for achieving the desired power is straightforward with true coefficient of variance (CV) estimates and true test/reference geometric mean ratios (GMRs) of selected parameters. However, true variance estimates are often not known and are, instead, based on published literature or pilot trials. An open-label, two-stage, adaptive, sequential two...

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...

Bioequivalence of two brands of gentamicin injection were studied in twelve clinically healthy goats. Single dose, equivalent to 5 mg gentamicin/kg.b.wt. was administered intramuscular to the subjects in a parallel two way crossover design. The studied non-innovator brand (Opigent 10%) were biologically equivalence with Garamicin 4% as innovator (no statistically significant difference were obs...

AIM The aim of this study was to compare human pharmacokinetics and bioequivalence metrics in saliva versus plasma for azithromycin as a model class I drug of the Salivary Excretion Classification System (SECS). METHODS A pilot, open-label, two-way crossover bioequivalence study was done, and involved a single 500-mg oral dose of azithromycin given to eight healthy subjects under fasting cond...

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 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...