An alternative index for assessing profile similarity in bioequivalence trials

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

In a typical bioequivalence trial, summary measures of the plasma concentration versus time profile are used to compare two formulations of a drug product. Commonly used measures include area under the curve (AUC), maximum plasma concentration (C(max)) and time to maximum concentration (T(max)). Equivalence of these summary measures, in general, does not guarantee equivalence of the entire profile. Rescigno and Chinchilli and Elswick propose indices which measure profile similarity, but can be overly sensitive to unimportant differences and are not easily interpreted pharmacologically. We propose an alternative index based on smoothing the relative difference between bioavailability profiles. This provides a method for assessing bioequivalence over the entire profile which has a familiar interpretation and can be tuned to provide a compromise between the insensitivity to pattern differences of summary measures and the oversensitivity of pointwise comparisons. Copyright (C) 2000 John Wiley and Sons, Ltd.

Original languageEnglish (US)
Pages (from-to)2855-2866
Number of pages12
JournalStatistics in Medicine
Volume19
Issue number20
DOIs
StatePublished - Oct 30 2000

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Bioequivalence
Therapeutic Equivalency
Drug Compounding
Alternatives
Biological Availability
Area Under Curve
Difference pattern
Plasma
Equivalence
Entire
Insensitivity
Smoothing
Drugs
Profile
Similarity
Curve
Formulation

All Science Journal Classification (ASJC) codes

  • Epidemiology
  • Statistics and Probability

Cite this

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abstract = "In a typical bioequivalence trial, summary measures of the plasma concentration versus time profile are used to compare two formulations of a drug product. Commonly used measures include area under the curve (AUC), maximum plasma concentration (C(max)) and time to maximum concentration (T(max)). Equivalence of these summary measures, in general, does not guarantee equivalence of the entire profile. Rescigno and Chinchilli and Elswick propose indices which measure profile similarity, but can be overly sensitive to unimportant differences and are not easily interpreted pharmacologically. We propose an alternative index based on smoothing the relative difference between bioavailability profiles. This provides a method for assessing bioequivalence over the entire profile which has a familiar interpretation and can be tuned to provide a compromise between the insensitivity to pattern differences of summary measures and the oversensitivity of pointwise comparisons. Copyright (C) 2000 John Wiley and Sons, Ltd.",
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An alternative index for assessing profile similarity in bioequivalence trials. / Mauger, David; Chinchilli, Vernon.

In: Statistics in Medicine, Vol. 19, No. 20, 30.10.2000, p. 2855-2866.

Research output: Contribution to journalArticle

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