BACKGROUND In clinical practice, α₂-adrenoceptor agonists have been adjunctively administered with psychostimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD). Two studies have examined the adjunctive use of guanfacine extended release (GXR, Intuniv®; Shire Development LLC, Wayne, PA, USA) with psychostimulants in children and adolescents with a suboptimal response to ...

BACKGROUND Itraconazole is commonly used to treat systemic fungal infections in dogs, but problems exist with absorption and cost. OBJECTIVE To determine oral bioequivalence of generic and compounded itraconazole compared to original innovator (brand name) itraconazole in healthy dogs. ANIMALS Nine healthy, adult research Beagle dogs. METHODS A randomized, 3-way, 3-period, crossover desig...

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...

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...

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...

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...

BACKGROUND AND OBJECTIVE A novel tiotropium bromide monodose capsule dry powder inhaler (DPI) formulation and device have been developed. The formulation was based on a spray-dried matrix that enhances the aerosolizaton properties, allowing a less active tiotropium metered dose (13 µg/capsule) while maintaining the same delivered dose (10 µg/actuation). This study describes the pharmacokinetic ...

Cefixime is a broad-spectrum oral antibiotic used for treating wide variety of bacterial infections. This investigation was aimed to study the pharmacokinetics and bioequivalence new generic suspension containing 100 mg cefixime trihydrate per 5 ml as test product against reference formulation Suprax® after administration 28 Arabic healthy male adult subjects under fasting condition. Ten millil...

Evaluating agreement between measurement methods or between observers is important in method comparison studies and in reliability studies. Often we are interested in whether a new method can replace an existing invasive or expensive method, or whether multiple methods or multiple observers can be used interchangeably. Ideally, interchangeability is established only if individual measurements f...