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  1. Journal of Pharmacokinetics and Pharmacodynamics
  2. Journal of Pharmacokinetics and Pharmacodynamics : Volume 34
  3. Journal of Pharmacokinetics and Pharmacodynamics : Volume 34, Issue 4, August 2007
  4. Bioequivalence testing by statistical shape analysis
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Journal of Pharmacokinetics and Pharmacodynamics : Volume 44
Journal of Pharmacokinetics and Pharmacodynamics : Volume 43
Journal of Pharmacokinetics and Pharmacodynamics : Volume 42
Journal of Pharmacokinetics and Pharmacodynamics : Volume 41
Journal of Pharmacokinetics and Pharmacodynamics : Volume 40
Journal of Pharmacokinetics and Pharmacodynamics : Volume 39
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Journal of Pharmacokinetics and Pharmacodynamics : Volume 37
Journal of Pharmacokinetics and Pharmacodynamics : Volume 36
Journal of Pharmacokinetics and Pharmacodynamics : Volume 35
Journal of Pharmacokinetics and Pharmacodynamics : Volume 34
Journal of Pharmacokinetics and Pharmacodynamics : Volume 34, Issue 6, December 2007
Journal of Pharmacokinetics and Pharmacodynamics : Volume 34, Issue 5, October 2007
Journal of Pharmacokinetics and Pharmacodynamics : Volume 34, Issue 4, August 2007
Weighted target interval stochastic control methods with global optimization and their applications in individualizing therapy
Bioequivalence testing by statistical shape analysis
The lasso—a novel method for predictive covariate model building in nonlinear mixed effects models
Pharmacodynamic analysis of time-variant cellular disposition: reticulocyte disposition changes in phlebotomized sheep
Estimation of the comparative therapeutic superiority of QD and BID dosing regimens, based on integrated analysis of dosing history data and pharmacokinetics
Pharmacodynamic model of interleukin-21 effects on red blood cells in cynomolgus monkeys
Journal of Pharmacokinetics and Pharmacodynamics : Volume 34, Issue 3, June 2007
Journal of Pharmacokinetics and Pharmacodynamics : Volume 34, Issue 2, April 2007
Journal of Pharmacokinetics and Pharmacodynamics : Volume 34, Issue 1, February 2007
Journal of Pharmacokinetics and Pharmacodynamics : Volume 33
Journal of Pharmacokinetics and Pharmacodynamics : Volume 32
Journal of Pharmacokinetics and Pharmacodynamics : Volume 31
Journal of Pharmacokinetics and Pharmacodynamics : Volume 30
Journal of Pharmacokinetics and Pharmacodynamics : Volume 29
Journal of Pharmacokinetics and Pharmacodynamics : Volume 28
Journal of Pharmacokinetics and Pharmacodynamics : Volume 27
Journal of Pharmacokinetics and Pharmacodynamics : Volume 26
Journal of Pharmacokinetics and Pharmacodynamics : Volume 25

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Bioequivalence testing by statistical shape analysis

Content Provider SpringerLink
Author Pereira, Luis Marcelo
Copyright Year 2007
Abstract Bioequivalence testing has been traditionally centered in summary variables such as AUC, C $_{max}$ and t $_{max}$ which filter out the intrinsic information conveyed by discrete sequential concentration–time observations. Comparing entire concentration–time profiles between test and reference formulations for bioequivalence purposes provides stronger evidence about either their similarity or their discrepancy. The Kullback–Leibler information criterion (KLIC) may be computed for each concentration–time across all subjects between formulations of the same drug, with a standard crossover study design. It has been shown that if properly scaled it follow a chi-squared distribution and dependent p-values may be computed in order to construct a bioequivalence criterion. Extensive simulations and real data were used to compare it with the current standard procedures. This statistical shape analysis method may provide important clinical and regulatory advantages.
Starting Page 451
Ending Page 484
Page Count 34
File Format PDF
ISSN 1567567X
Journal Journal of Pharmacokinetics and Pharmacodynamics
Volume Number 34
Issue Number 4
e-ISSN 15738744
Language English
Publisher Kluwer Academic Publishers-Plenum Publishers
Publisher Date 2007-06-07
Publisher Place New York
Access Restriction Subscribed
Subject Keyword Bioequivalence Shape analysis Information KLIC Kullback–Leibler Biochemistry Biomedical Engineering Veterinary Medicine Pharmacy Pharmacology/Toxicology
Content Type Text
Resource Type Article
Subject Pharmacology
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