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Moment-based criteria for determining bioequivalence
Daniel J. Holder,Francis Hsuan +1 more
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In this article, a moment-based criterion was proposed to insure interchangeability of formulations for at least a certain proportion of the population, and an algorithm was given for determining the constant in the criterion.Abstract:
SUMMARY In comparative bioavailability trials, the focus in the determination of bioequivalence has been to show that the average bioavailability on a test formulation is similar to the average bioavailability on a reference formulation. It has been argued that this is not adequate to insure interchangeability of formulations. We introduce a moment-based criterion which ensures interchangeability for at least a certain proportion of the population. An algorithm is given for determining the constant in the criterion. An example is used to illustrate how the criterion may be applied.read more
Citations
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Statistical methods in assessing agreement: Models, issues, and tools
TL;DR: In this article, the authors review the literature and present methodologies in terms of coverage probability for all of the aforementioned measurements when the target values are fixed and when the error structure is homogenous or heterogeneous.
Journal Article
Statistical approaches to establishing bioequivalence
TL;DR: In this article, the principle of statistical approaches to establish BE, the way to predetermine criterions and BE limits were introduced, and an example were illustrated, and the method of the statistical approach to establish the BE limits was introduced.
Journal ArticleDOI
Total deviation index for measuring individual agreement with applications in laboratory performance and bioequivalence.
TL;DR: A new user-friendly statistic, the total deviation index (TDI(1-p), is introduced that translates the mean of the squared difference between observations and target values (MSD) into an index that can be directly compared to a predetermined criterion.
Book
Statistical Tools for Measuring Agreement
TL;DR: This paper presents a basic approach for paired continuous data when target values are random or fixed and a unified approach for continuous and categorical data.
Journal ArticleDOI
Nonparametric validation of similar distributions and assessment of goodness of fit
Axel Munk,Claudia Czado +1 more
TL;DR: In this paper, an asymptotic test based on an (x-trimmed version of Mallows distance r,(F, G) between F and G is suggested, thus demonstrating the similarity of F and g within a pre-assigned r, (F,G) neighbourhood at a controlled type I error rate.
References
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Journal ArticleDOI
Random-effects models for longitudinal data
Nan M. Laird,James H. Ware +1 more
TL;DR: In this article, a unified approach to fitting two-stage random-effects models, based on a combination of empirical Bayes and maximum likelihood estimation of model parameters and using the EM algorithm, is discussed.
Book
Design and Analysis of Bioavailability and Bioequivalence Studies
Shein-Chung Chow,Jen-pei Liu +1 more
TL;DR: The Study Objectives Basic Design Considerations The Parallel Design The Crossover Design The Balanced Incomplete Block Design The Selection of Design Statistical Inference for Effects from a Standard 2 x 2 C crossover Design.
Journal ArticleDOI
An Introduction to Probability Theory and Mathematical Statistics.
Journal ArticleDOI
Consideration of individual bioequivalence.
Sharon Anderson,Walter W. Hauck +1 more
TL;DR: This work proposes a simple, valid statistical procedure, TIER (Test of Individual Equivalence Ratios), which requires the specification of the minimum proportion of subjects in the applicable population for which the two formulations being tested must be bioequivalent (a regulatory decision).