a convenient liquid chromatographic-single quadrupole mass spectrometric (lc-ms) method was developed and validated for dexchlorpheniramine maleate (inn name: chlorphenamine) determination in human plasma. the need for just a single liquid-liquid extraction with ethyl acetate and being highly sensitive were the advantages of this method. the linearity was also excellent over the range of 1 to 1...

background: closantel is a broad-spectrum antiparasiticagent and is widely used for the control of fasciola spp. andhaemonchus spp. infestations in sheep and cattle. objectives:the present study was carried out to evaluate the bioequivalenceof a domestic closantel formulation, fascinil® (damloranpharmaceutical co., iran), in comparison with flukiver®(janssen pharmaceutical co., belgium) in shee...

background methotrexate is a folic acid antagonist that has been in clinical use for five decades. its use in patients with brain tumors is primarily confined to primary central nervous system lymphoma (pcnsl), in which it is the cornerstone of chemotherapy. objectives a selective and sensitive high-performance liquid chromatography-electrospray ionization-mass spectrometry method was developed...

INTRODUCTION Pirfenidone film-coated tablets were developed to offer an alternative to the marketed capsule formulation. This study assessed the bioequivalence of the tablet and capsule formulations under fed and fasted states. METHODS A Phase I, open-label, randomized, four-treatment-period, four-sequence, crossover pharmacokinetics study (NCT02525484) was conducted. Each subject received an...

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...

When an innovative (brand-name) drug is going off patent protection, the innovative drug companies and/or generic drug companies may file an abbreviated new drug application (ANDA) for generic approval through the conduct of a bioequivalence study. Bioequivalence testing for generic approval is based on the Fundamental Bioequivalence Assumption that when two drug products have similar drug abso...

The aim of the evaluation was to establish bioequivalence between two oral 3.0 g sachet forms of L-ornithine-L-aspartate (LOLA). It was designed as randomised, two-way crossover study with a 1-week washout interval. Blood samples were collected throughout a 12 h period after administration of reference and test product to 12 fasting healthy male volunteers. Plasma were analyzed by sensitive, re...

Introduction. As a part of the registration drug product bioequivalence study fixed-dose combination "Ezetimibe + rosuvastatin" (JSC "Sanofi-aventis group", Russia) compared with coadministered Ezetrol® (ezetimibe) and Crestor® (rosuvastatin) was conducted 76 healthy volunteers. Enzymatic hydrolysis used to evaluate pharmacokinetics total ezetimibe. This reason for inclusion additional monitore...

The objective of this study was to assess the bioequivalence between the omeprazole laboratory based formulation and the commercial formulation, Zimor Rubio, Spain, considered as reference formulation. The experiment was carried out according to a 2-period, 2-sequence crossover design with a two week washout period. A validated high performance liquid chromatographic method was applied for in v...

OBJECTIVE To compare the clinical efficacy and bioequivalence of generic immunosuppressive drugs in patients with solid organ transplants. DESIGN Systematic review and meta-analysis of all studies comparing generic with innovator immunosuppressive drugs. DATA SOURCES Medline and Embase from 1980 to September 2014. REVIEW METHODS A literature search was performed for all studies comparing ...