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Guidance for Industry: Statistical Approaches to Establishing Bioequivalence.


PB2010104191

Publication Date 2001
Page Count 48
Abstract This guidance provides recommendations to sponsors and applicants who intend, either before or after approval, to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and supplements to these applications. This guidance discusses three approaches for BE comparisons: average, population, and individual. The guidance focuses on how to use each approach once a specific approach has been chosen. This guidance replaces a prior FDA guidance entitled Statistical Procedures for Bioequivalence Studies Using a Standard Two- Treatment Crossover Design, which was issued in July 1992.
Keywords
  • Prescription drugs
  • Drugs
  • Statistical models
  • Statistical analysis
  • Population
  • Individual
  • Sample sizes
  • Dropouts
  • Data analysis
  • Recommendations
  • Drug products
  • Logarithmic transformation
  • Bioequivalence
  • Industry guidances
  • New drug applications
  • Food and Drug Administration (FDA)
Source Agency
  • Food and Drug Administration
Corporate Authors Food and Drug Administration, Rockville, MD. Center for Drug Evaluation and Research.
Document Type Technical Report
NTIS Issue Number 201007
Guidance for Industry: Statistical Approaches to Establishing Bioequivalence.
Guidance for Industry: Statistical Approaches to Establishing Bioequivalence.
PB2010104191

  • Prescription drugs
  • Drugs
  • Statistical models
  • Statistical analysis
  • Population
  • Individual
  • Sample sizes
  • Dropouts
  • Data analysis
  • Recommendations
  • Drug products
  • Logarithmic transformation
  • Bioequivalence
  • Industry guidances
  • New drug applications
  • Food and Drug Administration (FDA)
  • Food and Drug Administration
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