Atorvastatin is a lipid-lowering agent, approved for treatment once daily at 10-80 mg doses in adults and at 10-20 mg doses in children aged 10 years or older [15]. Following oral administration, atorvastatin is rapidly absorbed, and maximum plasma concentrations are achieved within 1 to 2 hours. Atorvastatin is extensively metabolized by cytochrome P450 3A4 to active metabolites: orthoand para...

BACKGROUND Tramadol hydrochloride is available as 50 mg immediate-release (IR) and 100 mg, 200 mg, and 300 mg sustained-release (SR) tablets. The recommended dose of tramadol is 50-100 mg IR tablets every 4-6 hours. The tramadol SR 200 mg tablet is a better therapeutic option, with a reduced frequency of dosing, and improved patient compliance and quality of life. The present study evaluated th...

PURPOSE The purpose of this computer simulation was to determine the likelihood of two bioequivalent (vs. reference) generic warfarin formulations (with varying bioavailability) passing current bioequivalence criteria against each other at varying bioavailability. Methods. A bioequivalence simulation program generated 100 warfarin bioequivalence (BE) studies with 24 patients/study. The referenc...

BACKGROUND Preclinical studies comparing paclitaxel formulated with polyethoxylated castor oil with the sonicated formulation of liposome-entrapped paclitaxel (LEP) have demonstrated that LEP was associated with reduced toxicity while maintaining similar efficacy. Preliminary studies on the pharmacokinetics in patients support earlier preclinical data, which suggested that the LEP Easy-to-Use (...

The pharmacokinetics of olanzapine are linear and doseproportional within the approved dosage range from 1 mg up to 20 mg. Olanzapine is well absorbed following oral administration in both fed and fasted states . Food does not affect the rate or the extent of olanzapine absorption. Time of peak concentration ranges from 2-7 h [4,5]. Olanzapine is extensively distributed throughout the body, bin...

Objective: To determine the bioequivalence of two marketed test formulations (A, B) as compared to a reference formulation (R) of slow release theophylline in healthy volunteers. Material and Methods: The study was conducted as an open label, balanced, randomized, threetreatment, three-period, three-sequence single-dose crossover study to determine the bioequivalence of Phylobid 200 mg SR table...

The FDA Biopharmaceutical Classification System guidance allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms only for BCS class I. Extensions of the in vivo biowaiver for a number of drugs in BCS class III and BCS class II have been proposed, in particular, BCS class II weak acids. However, a discrepancy between the in vivo BE resu...

The aim of this study is to assess the quality of Valzan(®) tablet (160 mg, valsartan immediate release test formulation) by comparing its pharmacokinetic parameters with Diovan(®) tablet (160 mg, valsartan reference formulation). Valzan(®) tablets were prepared according to a dry granulation method (roll compaction). To assess the bioequivalence of Valzan(®) tablets a randomized, two-way, cros...

Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigate whether locally marketed amoxicillin tablets have the required chemical and physical attributes, including in vitro bioequivalence performance. Five generic products (T1, T2, T3, T4, and T5) cont...

The objective of this study was to investigate the bioequivalence of two formulations of 5 mg donepezil HCL tablets: Tonizep as the test and Aricept as the reference. The two products were administered as a single oral dose according to a randomized two-phase crossover with a 3-week washout period in 20 healthy Thai Male volunteers. After drug administration, serial blood samples were collected...