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A practical approach for evaluating population and individual bioequivalence

✍ Scribed by A. Lawrence Gould

Publisher
John Wiley and Sons
Year
2000
Tongue
English
Weight
146 KB
Volume
19
Category
Article
ISSN
0277-6715

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πŸ“œ SIMILAR VOLUMES

A PARAMETRIC APPROACH TO POPULATION BIOE
A PARAMETRIC APPROACH TO POPULATION BIOEQUIVALENCE
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Pharmaceutical companies conduct bioequivalence studies to demonstrate that a new formulation of a drug product ('Test') is sufficiently similar in rate and extent of absorption to the current formulation ('Reference'). Such similarity permits the efficacy and safety results for the Reference formul

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The two-period cross-over design with two sequences of drug administration is a standard experimental design when bioequivalence of one test formulation is to be assessed in comparison with a reference formulation. Previously, an approach based on Fieller's confidence interval has been presented for