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Articles Related to Bioequivalence

Bioequivalence Study of Donepezil 10 mg Orally Disintegrating Tablets in Healthy Thai Volunteers Under Fasting Conditions

Donepezil is a potent, selective, noncompetitive and reversible inhibitor of acetylcholinesterase, commonly used for the treatment of Alzheimer’s disease. The form of orally disintegrating tablets (ODTs) is a good alternative dosage form for patients who have a difficulty in swallowing conventional tablets or capsules.
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Comparative Bioequivalence Studies of Pantoprazole 40 mg Delayed-Release Tablet Formulations in Healthy Thai Volunteers

Pantoprazole is a H+,K+-ATPase enzyme inhibitor for the treatment of acid-related gastrointestinal diseases. The Government Pharmaceutical Organization (GPO), Thailand had developed Pantoprazole GPO® (pantoprazole 40 mg delayed-release tablets) as a generic substitute for the corresponding innovator product, CONTROLOC® 40 mg.
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Population Bioequivalence (PBE) Statistical Method to Evaluate Particle Size Distribution of Unilamellar Liposomes Constructed by Microfluidic Chip

Due to the high variability characteristics of liposome products and the influence of particle size on the distribution, tissue targeting behavior and clinical efficacy of liposomes, population bioequivalence (PBE) statistical method was selected to evaluate the consistency of particle size distribution of liposomes continuously prepared by microfluidic chip technology.
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Bioequivalence of Two Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate 600/200/300 mg Fixed-Dose Combination Tablets in Healthy Thai Male Volunteers under Fasting Conditions

Fixed-dose combination tablet formulation of efavirenz/emtricitabine/tenofovir disoproxil fumarate 600/200/300 mg is an antiretroviral therapy comprising one non-nucleoside reverse-transcriptase inhibitor and two nucleoside reverse-transcriptase inhibitors to control human immunodeficiency virus infection.
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Bioequivalence Evaluation of Two Clopidogrel Immediate Release Tablet Formulations in Healthy Thai Volunteers Under Fasting Conditions

Clopidogrel is used for acute coronary syndrome and prevention of atherothrombotic events. To improve clinical outcomes, patient adherence to treatment is necessary. However, continuous use of branded product may cause economic burden to patients and healthcare system. The Government Pharmaceutical Organization (GPO), Thailand had developed a generic product of clopidogrel to reduce cost of treatment and improve accessibility to medicines for Thai people.
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Bioequivalence between Two Capsules of Pirfenidonein Healthy Subjects under Fed Condition

Pirfenidone capsules are indicated for the treatment of patients with Idiopathic pulmonary fibrosis. The Bioavailability of two formulations containing pirfenidone 267 mg hard gelatin capsules was compared in a bioequivalence study under fed conditions. The study was single dose, randomized, open label, two-period crossover, with Brazilian healthy subjects, males and nonpregnant females.
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Bioequivalence between Two Tablets of Levetiracetam in Healthy Subjects under Fasting Condition

Bioavailability of two formulations containing levetiracetam 750 mg film-coated tablets was compared in a fasting bioequivalence study. The study was single dose, randomized, open label, and two-period crossover, with Brazilian healthy subjects, males and nonpregnant females. Blood samples were taken for 36 hours after drug administration and plasmatic concentrations were determined using a validated HPLC-MS/MS method. Confidence intervals (CI90%) for the peak plasma concentration (Cmax) and area under the concentration-time curve (AUC0-t) were determined by calculating LN-transformed data. The ratios and 90% CI for the geometric mean test/reference were 97.41% (91.45- 103.75%) for Cmax and 99.77% (97.07- 102.54%) for AUC0-t.
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Bioequivalence Study of Olanzapine 5 mg Orally Disintegrating Tablet Formulations in Healthy Thai Volunteers under Fasting Conditions

A comparative randomized, single dose, two-way crossover, open label study was carried out to assess bioequivalence and tolerability of test (ZOLAN GPO®) and reference (Zyprexa Zydis®) products of olanzapine 5 mg orally disintegrating tablets for interchange ability in the same quality and safety.
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Determination of N-Butylscopolamine in Human Plasma by Solid-Phase Extraction and UHPLC-ESI-MS/MS: Development, Validation and Application to a Bioequivalence Study

BioequivalenceA sensitive ultra performance liquid chromatography-electrospray ionization-tandem mass spectrometry (UHPLC-ESI-MS/MS) method for measurements of N-butylscopolamine in plasma was developed and validated. A SPE extraction was proposed for the clean up of plasma and N-butylscopolamine-d9 was added as internal standard. The analyses were carried out using a phenyl column and mobile phase of acetonitrile:
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A Bioequivalence Study of Two Formulations of Rosuvastatin

Aim of this study was to compare the bioavailability of two tablet formulations containing Rosuvastatin: Rosuvastatin tablets 40 mg manufactured by MacLeods Pharmaceuticals Ltd. (marketed in Italy with the brand name Exorta®) and CRESTOR® 40 mg tablets marketed by Astra Zeneca.
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A Bioequivalence Study of Two Formulations of Levetiracetam

This study was conducted to compare the bioavailability of 1000 mg levetiracetam film-coated tablet, marketed in Italy as Italept®, with Keppra® coated tablet.
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Bioequivalence between two extended Release Tablets of Oxycodone Hydrochloride in Healthy Subjects under Fasting and Fed Conditions

Bioavailability of different formulations of oxycodone 20 mg extended release tablets was compared in two bioequivalence studies, one under fasting conditions and the other one after a high-fat breakfast.
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Pharmacokinetics of a 1,000 mg Disintegrating Aspirin Tablet Formulation

Migraine is a global disorder and considerably affecting people`s quality of life. Treatments include nonsteroidal anti-inflammatory drugs-containing medicinal products among whom acetylsalicylic acid-containing Aspirin® has been proven effectively to relief migraine headache. Early treatment is recommended for patients with migraine attacks.
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Bioequivalence between two Prolonged Release Tablets of Desvenlafaxine Succinate in Healthy Subjects under Fasting and Fed Conditions

Bioavailability in different formulations of desvenlafaxine100 mg prolonged-release tablets was compared in two bioequivalence studies, one under fasting conditions and the other after a standard breakfast. Both studies were a single dose, randomized, open-label, two-period crossover, with Brazilian male and female healthy subjects. Blood samples were taken during 48 h and plasmatic concentrations were determined using a validated UPLC-MS/MS method.
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Bioequivalence between Generic Rasagiline (As Tartrate) and Rasagiline (As Mesylate)

The objective of the study was to compare bioavailability of 1 mg rasagiline (as tartrate) immediate release tablets and Azilect® 1 mg immediate release tablets.
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Editorial Board Members Related to Bioequivalence

Nashiru Billa

Associate professor
Faculty of Science
University of Nottingham
Malaysia

TAWFIK ALHUSSAINY

Professor
College of Pharmacy and Medical Sciences
University of Petra
Jordan

Eyad Mazin Mallah

Associate professor
Department of Pharmaceutical Medicinal Chemistry and Pharmacognosy
University of Petra
Jordan
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