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...

Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties of drug products. The in-vitro disintegration and dissolution times of tablets and capsules can vary significantly based on their composition and processing. Though small differences in-vitro dissolution are not expected...

*Corresponding author E mail: [email protected] J. Pharm. BioSci. 2(2014) 44-49 Abstract This study was to compare the bioavailability and pharmacokinetic properties of test product of Metformin hydrochloride extended release formulation of 1000 mg tablet with reference product of Metformin Hydrochloride (Glucophage®) extended release formulation of 1000 mg in Indian healthy male vo...

In this Perspective on the clinical trial by Rita Alloway and colleagues, Simon Ball explains the benefits to healthcare systems and individual patients of the bioequivalence established between generic and brand-name formulations of an immunosuppressive drug in transplant recipients.

Two randomized, single dose, 2-period, 2-sequence crossover studies were conducted to evaluate the comparative bioavailability of two clopidogrel formulations under fasting and fed conditions. Assessment of bioequivalence was based upon measurement of plasma concentrations of the parent drug, clopidogrel, and its major (inactive) metabolite, clopidogrel carboxylic acid, using improved methanol-...

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipient...

Standard 2X2 and replicated 2X2m crossover designs are recommended in the regulatory guidelines to establish bioequivalence of generic drug with off patent brand-name drug. Estimation of sample size, in any clinical trial, targets to optimize the resource usage with assurance of having adequate probability (power) to get significant result. This paper discusses the statistical concept behind sa...

Given the clinical success of commercial amphotericin B lipid products, investigators have begun making generic formulations of liposomal amphotericin B. Generic medicines are an attractive approach to help decrease the cost and accessibility to healthcare, provided that appropriate studies are performed to ensure bioequivalence with the parent product. This is of particular concern for liposom...

An analytical method based on solid phase extraction has been developed and validated for analysis of amoxicillin in human plasma using gemifloxacin as an internal standard. A COSMOSIL 5C18-PAQ column provided chromatographic separation of analytes followed by detection with mass spectrometry. The method involves simple isocratic chromatographic conditions and mass spectrometric detection in th...