A MODIFIED LARGE SAMPLE APPROACH IN THE ASSESSMENT OF POPULATION BIOEQUIVALENCE

The U.S. Food and Drug Administration (FDA) requires pharmaceutical companies to show bioequivalence between different formulations or generic companies to show bioequivalence between generic drugs and brand drugs before a9680186roval. In a recent FDA guidance on bioequivalence, new criteria were pr...

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Veröffentlicht in:	Journal of biopharmaceutical statistics 2000-11, Vol.10 (4), p.527-544
Hauptverfasser:	Quiroz, Jorge, Ting, Naitee, Wei, Greg C. G., Burdick, Richard K.
Format:	Artikel
Sprache:	eng
Schlagworte:	Algorithms Clinical Trials as Topic - statistics & numerical data Computer Simulation Confidence intervals Cross-Over Studies Crossover design Data Interpretation, Statistical FDA Population Research Design Sample Size Therapeutic Equivalency United States United States Food and Drug Administration Variance components
Online-Zugang:	Volltext
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