A bioequivalence study of two oral formulations of 500 mg cefuroxime axetil was carried out in 24 healthy volunteers following a single dose, standard two-treatment cross-over design at the College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, working jointly with King Khalid University Hospital. The two formulations used were Cefuzime (Julphar, United Arab Emirates) as the test and ...

PURPOSE The primary aim of the present study was to assess the pharmacokinetic bioequivalence between a generic formulation of meloxicam 15 mg tablets (Meloxicam Hexal) and its respective brand product (Mobic), in order to verify whether the generic product conforms to the regulatory standards of bioequivalence in the postmarketing setting. As a secondary exploratory aim, the pharmacodynamic ef...

OBJECTIVE The aim of this study was to evaluate the bioequivalence of two drug products, generic clopidogrel bisulfate 75 mg film-coated tablets versus the reference Plavix(®) clopidogrel bisulfate 75 mg film-coated tablets. METHODS Bioequivalence of tablets was tested by comparisons against the reference brand product in accordance with the requirements of the Declaration of Helsinki, the cu...

Abstact To determine the bioequivalence of two formulations of recombinant human erythropoietin alpha (epoetin alpha 4000-IU), the two formulations; Renogen® and the Reference, Eprex® were administered to 18 healthy Thai male volunteers as a single subcutaneous dose according to a randomized two-way crossover design. Serial blood samples were collected over a period of 96 hours. The pharmacokin...

Background: Tramadol is one of the most commonly used analgesics, thanks to its efficacy and safety. It is widely used in Myanmar for postoperative and cancer pain control. The use of generic drugs has been steadily increasing worldwide, mostly in developing countries. Generic drugs should have efficacy and safety comparable to their innovators or other approved generic products.  Objectives: ...

Bioequivalence studies on some selected brands of ciprofloxacin hydrochloride tablets in the Nigerian market with ciproflox® as innovator brandOsonwa Uduma E., Agboke Ayodeji A., Amadi Rosemary C., Okorie,Ogbonna, Opurum Christian C

Substitution of branded medicines by cheaper generic medicines has been and is subject for debate in the Netherlands. One of the tasks of the Dutch Medicines Evaluation Board (CBG) is the evaluation of generic medicines. The way the CBG approves generics, as outlined in this paper, is based on assessment of the quality of the medicine and bioequivalence testing according to strict European guid...

Regulatory criteria established for the acceptance of average bioequivalence do not fully satisfy the requirements arising for the interchangeability of drug products. The divergence is illustrated by noting that the regulatory criteria are compatible with large inter-individual variation of within-subject differences or ratios of the relevant kinetic parameters. Regulatory criteria of three ju...

The 2 × 2 crossover is commonly used to establish average bioequivalence of two treatments. In practice, the sample size for this design is calculated under an implicit belief that the true average bioavailabilities of the two treatments are (almost) identical. However, the ”standard” average bioequivalence analysis does not reflect this prior belief and this leads to a loss in efficiency. The ...