The present study was designed to assess the bioequivalence of two agomelatine formulations (25-mg tablets) in healthy Chinese male subjects. This single-dose, open-label, randomized, four-way replicate study with a 1-week washout period was conducted in 60 healthy Chinese male volunteers under fasting conditions. Blood samples were collected over a 12-h period after a single dose of the 25-mg ...

OBJECTIVE This study assessed relative bioavailability of a new subcutaneous formulation, test (T) (dalteparin sodium 95000 IU/3.8 mL) with the branded product (R) in healthy subjects to meet the regulatory requirements of bioequivalence in the US. METHODS This was an open label, randomized, single dose, two-sequence, two-period cross-over study under fasting conditions. A total of 88 healthy...

To assess the bioequivalence of two extended-release tablets of donepezil 23 mg, open label, randomized, single-dose, two-sequence, two-period crossover studies under fasting (n=74) and fed (n=94) conditions in healthy adult human volunteers were conducted. Subjects were randomized to either of the two treatment arms (test or reference) separated by a washout period of 28 days. Blood samples we...

PURPOSE This study was designed to characterize the pharmacokinetic profile and to assess bioequivalence of the sponsor's test formulation (imatinib mesylate 400 mg tablets) with an innovator product (Gleevec 400 mg tablets, Novartis Pharmaceuticals) under fed conditions, in adult patients of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) stabilized on imatinib mesylate 400...

OBJECTIVE To assess the bioequivalence of single dose trazodone hydrochloride USP 100 mg tablets administered as an oral dose under fed condition. METHODS This study was an open-label, balanced, randomized, two-sequence, two-treatment, two-period, single oral dose, crossover bioequivalence study in healthy, adult, human subjects under fed conditions. After an overnight fast of at least 10 h, ...

We give a new simpler proof along with a generalization for the inequality of Yao and Iyer [10] arising in bioequivalence studies and by using a nonparametric approach we also discuss an extension of the individual bioequivalence setting to the case where the data are not necessarily normally distributed.

Increased use of whole effluent toxicity (WET) tests in the regulatory arena has brought increased concern over the statistical analysis of WET test data and the determination of toxicity. One concern is the issue of statistical power. A number of WET tests may pass the current hypothesis test approach because they lack statistical power to detect relevant toxic effects because of large within-...

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...