Steady-state bioequivalence 2-way crossover study of two quetiapine prolonged-release 400 mg tablet formulations in normal male and female healthy subjects under fasting conditions .

Objective: The purpose of this study was to assess bioequivalence between a generic and a brand quetiapine 400 mg prolonged-release (PR) formulation (Pharmathen S.A.; AstraZeneca Seroquel Prolong®<) in healthy volunteers under steady-state conditions.

Large-scale retrospective evaluation of regulated liquid chromatography-mass spectrometry bioanalysis projects using different total error approaches.

The current approach in regulated LC-MS bioanalysis, which evaluates the precision and trueness of an assay separately, has long been criticized for inadequate balancing of lab-customer risks. Accordingly, different total error approaches have been proposed. The aims of this research were to evaluate the aforementioned risks in reality and the difference among four common total error approaches (β-expectation, β-content, uncertainty, and risk profile) through retrospective analysis of regulated LC-MS projects.

Some unnecessary or inadequate common practices in regulated LC-MS bioanalysis.

The global bioanalytical community increasingly craves scientifically sound practices and guidance where the rationale is given for each requirement. To this end, it is critical to first evaluate all the existing practices and requirements based on scientific findings and critical thinking. Here we are challenging several important common practices in regulated LC-MS bioanalysis, from the requirement of at least six different calibration concentrations, no extrapolation, use of blank and zero standard in each batch, selection of quality controls, to the way matrix effect and dilution integrity are being validated.

Impact of calibrator concentrations and their distribution on accuracy of quadratic regression for liquid chromatography-mass spectrometry bioanalysis.

Despite the common use of quadratic regression in LC-MS bioanalysis, how calibrator concentrations should be determined is still vague. Both the number and concentrations of calibrators are usually selected arbitrarily to each one's preference. The purposes of this research were to evaluate the impact of calibrator concentrations and to find new approaches with improved accuracy and reduced cost for LC-MS bioanalysis.

Comparison of two-concentration with multi-concentration linear regressions: Retrospective data analysis of multiple regulated LC-MS bioanalytical projects.

Linear calibration is usually performed using eight to ten calibration concentration levels in regulated LC-MS bioanalysis because a minimum of six are specified in regulatory guidelines. However, we have previously reported that two-concentration linear calibration is as reliable as or even better than using multiple concentrations. The purpose of this research is to compare two-concentration with multiple-concentration linear calibration through retrospective data analysis of multiple bioanalytical projects that were conducted in an independent regulated bioanalytical laboratory.

Comparison of different linear calibration approaches for LC-MS bioanalysis.

Many different calibration approaches are used for linear calibration in LC-MS bioanalysis, such as different numbers of concentration levels and replicates. However, direct comparison of these approaches is rare, particularly using experimental results. The purpose of this research is to compare different linear calibration approaches (existing and new ones) through simulations and experiments.

Single-dose, 2-way crossover, bioequivalence study of two rosuvastatin formulations in normal healthy subjects under fasting conditions.

Background: Rosuvastatin, a synthetic lipid-lowering agent acts selectively by competitive inhibition of 3-hydroxy- 3-methylglutaryl-coenzyme A. It is indicated as an adjunct to diet in patients with hypercholesterolemia and mixed dyslipidemia.

Objective: The purpose of this study was to demonstrate bioequivalence between a generic rosuvastatin 40 mg tablet (Zentiva, Prague, Czech Republic) and a reference product (Crestor, AstraZeneca, Luton, UK), under fasting conditions as required by the European Medicinal Agency.

Truncated areas under the curve in the assessment of pioglitazone bioequivalence. Data from a single-center, single-dose, randomized, open-label, 2-way cross-over bioequivalence study of two formulations of pioglitazone 45 mg tablets under fasting conditions.

Background: Pioglitazone (CAS 112529-15-4 for the HCl form) is an oral antidiabetic agent that is a member of the group of drugs known as thiazolidinediones. It is indicated for the treatment of type 2 diabetes mellitus.

Objective: The aim of this study was to assess the bioequivalence of a new pioglitazone 45 mg formulation (test formulation) vs.

Results of a single-center, single-dose, randomized-sequence, open-label, two-way crossover bioequivalence study of two formulations of valsartan 160-mg tablets in healthy volunteers under fasting conditions.

Background: Valsartan is a nonpeptide, orally active angiotensin II type 1 receptor blocker used to treat hypertension alone or in combination with other antihypertensive agents.

Objective: The aim of this study was to compare the relative bioavailability of a new valsartan 160-mg formulation (ie, test drug) and that of a reference formulation so that bioequivalence could be assessed, as required by European regulatory authorities for the marketing of a generic product.

Methods: This was a single-center, single-dose, randomized-sequence, open-label, 2-way crossover study with a minimum washout period of 7 days; drug was administered to healthy volunteers under fasting conditions.

Bioequivalence study of two enteric-coated formulations of pantoprazole in healthy volunteers under fed conditions.

This study was conducted in order to assess the bioequivalence of two enteric-coated formulations of 40 mg pantoprazole (CAS 102625-70-7), under fed conditions. Seventy-four healthy subjects, age ranging from 24 to 55 years, were enrolled in a two-centre, randomised, single-dose, open-label, 2-way crossover study, with a minimum washout period of 7 days. Plasma samples were collected up to 30.

Bioequivalence study of two letrozole tablet formulations. Single dose, randomized, open-label, two-way crossover bioequivalence study of letrozole 2.5 mg tablets in healthy volunteers under fasting conditions.

The study was conducted in order to compare the bioavailability of two tablet formulations containing letrozole 2.5 mg (CAS 112809-51-5). Twenty healthy subjects were enrolled in a single-centre, bioequivalence, randomised, single-dose, open-label, two-way crossover study, performed under fasting conditions with a minimum washout period of 21 days.

Truncated AUCs in the assessment of the bioequivalence of topiramate, a long half-life drug.

This study was conducted in order to assess the bioequivalence of two tablet formulations containing topiramate (CAS 97240-79-4), 25 mg. Twenty-four healthy volunteers were enrolled in an open-label, randomised, crossover, 2 periods x 2 sequences, with a minimum washout period of 21 days, single dose study. Blood samples were collected prior to study drug administration and 0.