A method for the determination of carvedilol in human plasma was developed using a high-performance liquid chromatography with tandem mass spectrometer (HPLC-MS/MS). Plasma samples were deproteinized using acetonitrile and the supernatant was directly injected onto the HPLC column without any preparative steps. Chromatography was performed on a reversed-phase (C18) column with isocratic mobile ...

glimepiride/metformin(2/500mg) is an oral antihyperglycemic agent for the treatment of type 2 diabetes. a generic glimepiride/metformin(2/500mg) fixed-dose combination(fdc) tablet was developed recently. this study was designed to collect data for submission to korean regulatory authorities to allow the marketing of the test formulation. we evaluated the comparative bioavailability and tolerabi...

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...

BACKGROUND AVI-014 is an egg white-derived, recombinant, human granulocyte colony-stimulating factor (G-CSF). This healthy volunteer study is the first human investigation of AVI-014. METHODS 24 male and female subjects received a single subcutaneous injection of AVI-014 at 4 or 8 mcg/kg. 16 control subjects received 4 or 8 mcg/kg of filgrastim (Neupogen, Amgen) in a partially blinded, parall...

The aim of the study was to evaluate if two capsules (Amoxil(®) capsules, 500 mg/capsule) and one tablet (Amoxicare(®) tablets, 1000 mg/tablet) of amoxicillin have similar bioequivalence parameters. For this purpose a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers, divided into two groups of 12 subjects each. One group was treated with the refe...

A randomized, two-way, crossover, bioequivalence study was conducted in 26 fasting, healthy, male volunteers to compare two brands of citalopram 40 mg tablets, Citol (Abdi Ibrahim Ilaç San. ve Tic A.S., Istanbul, Turkey) as a test and Cipramil (H. Lundbeck A/S, Copenhagen, Denmark) as a reference product. One tablet of either formulation was administered with low-carbonate water after 10 h of o...

AIM Determination of the bioequivalence of two ciprofloxacin tablet formulations (test formulation manufactured by Novell Pharmaceutical Laboratories, Indonesia, reference formulation from Quimica Farmaceutica Bayer, Spain). SUBJECTS AND METHODS 24 healthy volunteers received each of the two ciprofloxacin formulations at a dose of 500 mg in a 2-way crossover design. Blood samples were obtaine...

A single dose, crossover bioequivalence study of two different brands of clonidine hydrochloride 25 mug tablets was conducted in 24 (+2 stand by) healthy, adult, male, Indian subjects under fasting conditions to check the implication of enterohepatic re-circulation on assessment of bioequivalence. After an overnight fasting of at least 10 h, the subjects received single oral dose of test or ref...

To evaluate globally the average bioequivalence of a test drug to a reference drug in a pharmacokinetic (PK) study under a 2 x 2 crossover design, we consider directly comparing the associated drug concentration-time curves. Statistical models for the drug concentrations are suggested when the concentrations measured at different time points are distributed according to a generalized gamma dist...

OBJECTIVE To analyze the financial impact of medicine procurement with the required bioavailability and or bioequivalence tests for the basic pharmaceutical services component. METHODS A retrospective study, based on document research of competitive bidding for medicine procurement in a medium size municipality of Santa Catarina state, Southern Brazil. Bids that occurred with (2007) and witho...