In its recent guidance on bioequivalence, the U.S. Food and Drug Administration (FDA) recommends a two-sequence, four-period (2 x 4) replicated crossover design be used for assessment of population and individual bioequivalence [FDA. Guidance for Industry on Statistical Approaches to Establishing Bioequivalence; Center for Drug Evaluation and Research, Food and Drug Administration: Rockville, M...

As more and more generics become available in the market place, the safety/efficacy concerns may arise as the result of interchangeably use of approved generics. However, bioequivalence assessment for regulatory approval among generics of the innovative drug product is not required. In practice, approved generics are often used interchangeably without any mechanism of safety monitoring. In this...

OBJECTIVE The present study describes the determination of the bioequivalence of two different nevirapine tablet formulations (nevirapine tablets 200 mg, Novatec, as the test formulation vs. viramune tablets 200 mg, Boehringer Ingelheim, as the reference formulation). METHOD A single 200 mg oral dose of each preparation was administered to 11 human immunodeficiency virus (HIV)-infected patien...

GENERAL OBJECTIVE To evaluate the understanding and perceptions of generic medicines among final-year Doctor of Pharmacy students in Karachi, Pakistan. METHODS A 23-item survey instrument that included a question on the bioequivalence limits and Likert-type scale questions regarding the understanding and perceptions of generic medicines among the students was executed. Cronbach's alpha was fo...

Comparing modified-release formulations can be difficult using current bioequivalence criteria. Two 60-mg-once-daily nifedipine formulations are deemed bioequivalent in Canada. This study examined the validity of the assumption that these interchangeable, but different, delivery technologies are therapeutically equivalent in maintaining systolic blood pressure (SBP) control throughout the entir...

A sensitive and specific method based on liquid chromatography was developed and validated for the determination of phenytoin in human plasma using phenobarbital as internal standard. The drugs were extracted from plasma by liquid-liquid extraction and separated isocratically on a Phenomenex Synergi MAX-RP C12 column (150 x 4.6 mm i.d.), with water: acetonitrile: methanol (58.8:15.2:26, v/v/v) ...

in this study, the pharmacokinetic parameters of two marketed tablet formulations of ketoconazole were studied, and the relative bioavailability of the test formulation was compared with a reference formulation. a single dose (12x2) double blind randomized cross-over study of a generic formulation of ketoconazole tablet (2x200 mg), and a commercial brand, nizoral tablet (2x200 mg, janssen pharm...

Breast cancer is the most fatal form of cancer for female population worldwide. National Cancer Institute (NCI) estimates 226,870 females and 2,190 males to be diagnosed with breast cancer in the United States by the end of 2012. The estimated death toll for this year includes 39,510 females and 410 males, as reported by NCI. Statistics state that 1 in every 8 females will be diagnosed with bre...

Introduction Fosaprepitant, an intravenous (IV) aprepitant prodrug for chemotherapy-induced nausea and vomiting prophylaxis, is associated with systemic and infusion-site reactions attributed in part to its surfactant, polysorbate 80. HTX-019 is an IV aprepitant formulation free of polysorbate 80 and other synthetic surfactants. Materials and methods This open-label, single-dose, randomized, ...

We have read with interest the comments made on our study titled ‘Point of care (POC) D-dimer testing in the Emergency department–a bioequivalence study’ [1]. Ekelund and Heilmann, referring to the results and conclusions of the study, have suggested that one of the discrepancies may be caused by a typographical error, and this inference probably stems from the use of the term ‘range’ in the pu...