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Bioequivalence
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Abstract
Bioequivalence is defined as the comparable bioavailability of alternative drug formulations. Kinetic measures of bioavailability are reviewed, leading to a discussion of the statistical assessment of bioequivalence. Parametric and nonparametric methods of testing are described. Current research areas, including the estimation of individual bioequivalence and alternative measures for the evaluation of bioequivalence, are reviewed.
Title: Bioequivalence
Description:
Abstract
Bioequivalence is defined as the comparable bioavailability of alternative drug formulations.
Kinetic measures of bioavailability are reviewed, leading to a discussion of the statistical assessment of bioequivalence.
Parametric and nonparametric methods of testing are described.
Current research areas, including the estimation of individual bioequivalence and alternative measures for the evaluation of bioequivalence, are reviewed.
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A Multicenter Randomized Bioequivalence Study of a Novel Ready-to-Use Temozolomide Oral Suspension vs. Temozolomide Capsules
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Bioequivalence studies for pharmaceutical products
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Bioequivalence Estimation of Two Formulations of Cefixime Tablets among Healthy Chinese Volunteers under Fasting Condition
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Review of bioequivalence studies of cholecalciferol drugs
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Bioequivalence of budesonide/glycopyrrolate/formoterol fumarate with a next-generation propellant versus hydrofluoroalkane-134a in healthy adults: phase I, randomized, double-blind, single-dose, partial-replicate, three-way cross-over lung exposure and to
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Background:
Hydrofluoroolefin-1234ze (HFO-1234ze) is a next-generation propellant with 99.9% lower global warming potential (GWP) than hydrofluoroalkane-134a (H...
Bioequivalence
Bioequivalence
Abstract
Bioequivalence is defined as the comparable bioavailability of alternative drug formulations. Kinetic measures of bioavailability are reviewed, leading to a disc...
Reversed Phase High Performance Liquid Chromatographic Method for Determination of Sildenafil in Human Plasma and its Application to a Bioequivalence Study
Reversed Phase High Performance Liquid Chromatographic Method for Determination of Sildenafil in Human Plasma and its Application to a Bioequivalence Study
Sildenafil Citrate is a drug used to treat erectile dysfunction and pulmonary arterial hypertension (PAH). A sensitive and specific method based on High Performance Liquid Chromato...
BioequivalenceArticle originally published in
Encyclopedia of Biostatistics, 2nd Edition
(2005, John Wiley & Sons, Ltd).
BioequivalenceArticle originally published in
Encyclopedia of Biostatistics, 2nd Edition
(2005, John Wiley & Sons, Ltd).
Abstract
Bioequivalence is defined as the comparable bioavailability of alternative drug formulations. Kinetic measures of bioavailability are reviewed, leading to a disc...