In the pharmacokinetic (PK) study under a 2x2 crossover design that involves both the test and reference drugs, we propose a mixed-effects model for the drug concentration-time profiles obtained from subjects who receive different drugs at different periods. In the proposed model, the drug concentrations repeatedly measured from the same subject at different time points are distributed accordin...

In this study, an open, double-blind, randomized, two-period, two-group crossover design was conducted in 14 healthy volunteers to study the bioequivalence of a fixed-dose generic product. After administration of test or reference products to each volunteer, both active ingredients were determined simultaneously in plasma samples using a developed and validated HPLC-UV method, and pharmacokinet...

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...

Introduction: Systemic corticosteroids are anti-inflammatory agents with dexamethasone among the most potent in the class. Within (respiratory) allergy, systemic corticosteroids are usually applied in medical emergencies. In these situations, patients may experience physical or logistic problems taking tablets. To fulfil a practical unmet need for outpatients, Dexa ODF, an oral dissolvable film...

AIMS This bioequivalence study was conducted to assess the bioequivalence of two formulations, test and reference, of pregabalin 300 mg hard capsules, under fasting conditions. METHODS This was a single-center, randomized, single-dose, open-label, laboratory-blinded, two-way crossover study, with a minimum washout period of 7 days. Plasma samples were collected prior to and up to 36 h after d...

Background: Deferasirox is an orally bioavailable synthetic, tridentate iron chelator that binds iron at a 2:1 ratio. The generic brand for this drug is still not available in Indonesia. We aimed to compare the efficacy between the generic drug and its innovator (Exjade®) by a study of bioequivalence in Indonesia among healthy volunteers. Methods: An open-label, single-dose, two-sequence, rand...

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...

Azithromycin, 9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin a dihydrate, is a semi-synthetic 15-membered azalide antibiotics derived from erythromycin. Its chemical structure differs from that of erythromycin by the insertion of methyl-substituted nitrogen at position 9a in the lactone ring. This modification results in the improved acid stability associated with more reliable and greater oral b...