Objective: A randomized, open-label, balanced, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Rizatriptan 10 mg Orally Disintegrating Strips (ODS, test) with that of established Oral Lyophilisate mg, Maxalt-MLT® (reference) was conducted in 24 healthy male volunteers under fasting conditions. single oral dose administrated to each volunteer. Metho...

An analytical method based on solid phase extraction has been developed and validated for analysis of amoxicillin in human plasma using gemifloxacin as an internal standard. A COSMOSIL 5C18-PAQ column provided chromatographic separation of analytes followed by detection with mass spectrometry. The method involves simple isocratic chromatographic conditions and mass spectrometric detection in th...

objective(s) a sensitive liquid chromatographic method for the analysis of clarithromycin- a macrolide antibiotic- in human serum, using pre-column derivatization with 9-fluorenylmethyl chloroformate (fmoc-cl) is described. materials and methods the method involved liquid-liquid extraction of the drug and an internal standard (amantadine) followed by pre-column derivatization of the analytes wi...

bioequivalence study is a scientific and practical method used to compare the quality of a generic drug with a reference product. this study aimed to examine the bioequivalence of two closantel formulations produced with different sources of raw material by a domestic pharmaceutical company. due to long half- life of closantel, the study carried out by a parallel method. thirty sheep were divid...

In this study, the modern tool of machine learning is used to address an old problem from a new perspective. Traditionally, scientific basis for determining bioequivalence based on pharmacokinetic comparison, specifically rate and extent absorption between two products. Even though it generally agreed that peak plasma concentration (Cmax) should be measure absorption, several studies have raise...

I. INTRODUCTION When the drug can be absorbed by the blood system, the bioequivalence of a generic drug is evaluated with a crossover design based on pharmacokinetic endpoints. However, for treatment of non-systemic symptoms, bioequivalence evaluation is regularly designed as a randomized clinical trial with three parallel treatment groups – T, the test treatment group, R, the reference treatme...

This was a Phase I, open-label, randomized, two-period, two-sequence crossover study [ClinicalTrials.gov NCT02317809 (https://www.clinicaltrials.gov/ct2/show/NCT02317809); EudraCT 2014-003506-32] assessing the bioequivalence of the liquid and freeze-dried formulations of fixed-dose, fixed-ratio (2:1) combination recombinant human follicle-stimulating hormone plus recombinant human luteinizing h...

Back in 2009, we concluded that veterinary pharmacology was sorely in need of a bioequivalence initiative. Despite the pharmacological and statistical advances that have occurred since the early days of bioequivalence assessments, unresolved issues remain. While many of these issues are common to both human and veterinary medicine, there are also challenges specific to veterinary drug products....

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...