M Carmen Pardo, Alba M Franco-Pereira, Benjamin Reiser, Christos T Nakas
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Confidence intervals for the covariate-specific overlap coefficient (OVL).
The overlap coefficient () quantifies the similarity between two distributions through the overlapping area of their distribution functions. It has been discussed in the literature in a variety of different contexts. One approach for testing the bioequivalence of treatments is to measure the overlap of the distributions of individual responses to therapy. In some situations, covariates can significantly influence distributional overlap. This paper develops a covariate-specific estimator using linear regression with a possible Box-Cox transformation. Bootstrap-based confidence intervals for the covariate-specific are proposed and evaluated through extensive simulations. The methodology is illustrated using fingerstick post-prandial blood glucose measurements as a biomarker for diabetes patients adjusted for age.
期刊介绍:
The Journal of Biopharmaceutical Statistics, a rapid publication journal, discusses quality applications of statistics in biopharmaceutical research and development. Now publishing six times per year, it includes expositions of statistical methodology with immediate applicability to biopharmaceutical research in the form of full-length and short manuscripts, review articles, selected/invited conference papers, short articles, and letters to the editor. Addressing timely and provocative topics important to the biostatistical profession, the journal covers:
Drug, device, and biological research and development;
Drug screening and drug design;
Assessment of pharmacological activity;
Pharmaceutical formulation and scale-up;
Preclinical safety assessment;
Bioavailability, bioequivalence, and pharmacokinetics;
Phase, I, II, and III clinical development including complex innovative designs;
Premarket approval assessment of clinical safety;
Postmarketing surveillance;
Big data and artificial intelligence and applications.