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...

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...

      In this study, the pharmacokinetic parameters of two marketed tablet formulations of ketoconazole were studied, and the relative bioavailability of the test formulation was compared with a reference formulation. A single dose (12x2) double blind randomized cross-over study of a generic formulation of ketoconazole tablet (2x200 mg), and a commercial brand, Nizoral tablet (2x200 mg, Janssen...

BACKGROUND We aimed to compare the steady-state pharmacokinetic parameters and tolerability of Triomune 40 (stavudine 40 mg, lamivudine 150 mg and nevirapine 200 mg) and branded formulations of these drugs in HIV-infected Ugandans. METHODS This includes a randomized, open-label, cross-over study of HIV-infected patients stable on therapy for 1 month. Patients were randomized to generic or bra...

OBJECTIVE To systematically review the literature on generic antiepileptic drugs (AEDs), evaluate the efficacy and safety of generic AED substitution, and perform pharmacokinetic (PK) analysis using the American Academy of Neurology (AAN) scheme to classify evidence. DATA SOURCES PubMed and Cumulative Index to Nursing and Allied Health Literature searches from January 1, 1980, to October 15, ...

BACKGROUND Generic drugs are used by millions of patients for economic reasons, so their evaluation must be highly transparent. OBJECTIVE To assess the quality of reporting of bioequivalence trials comparing generic to brand-name drugs. METHODOLOGY/PRINCIPAL FINDINGS PubMed was searched for reports of bioequivalence trials comparing generic to brand-name drugs between January 2005 and Decem...

BACKGROUND Currently, less frequent than once-weekly subcutaneous epoetin administration regimens were shown to be equally effective and safe as once-weekly schedules in stable predialysis and peritoneal dialysis patients. Bioequivalency of once-every-2-weeks and once-weekly subcutaneous administration of the same total dose of epoetin beta for the maintenance phase of anemia treatment in stabl...

in this study, the pharmacokinetic parameters of two marketed tablet formulations of ketoconazole were studied, and the relative bioavailability of the test formulation was compared with a reference formulation. a single dose (12x2) double blind randomized cross-over study of a generic formulation of ketoconazole tablet (2x200 mg), and a commercial brand, nizoral tablet (2x200 mg, janssen pharm...

The aim of present study was to compare the quality of atenolol tablets and examine the possibility of biowaiver study for approval of generic drugs without additional in vivo bioequivalence study. Atenolol, a cardio selective β-blocker, could be clearly classified into BCS Class III and may be evaluated under biowaiver conditions. Due to the importance of atenolol and availability of different...

1. On request of the pharmacist, the supplier should furnish a. Analytical control data. b. Sterility testing data. c. Bioavailability data. d. Bioequivalency data. e. Descriptions of testing procedures for raw materials and finished products. f. Any other information that may be indicative of the quality of a given finished drug product. Testing data developed by independent laboratories shoul...