Reference Datasets for Studies in a Replicate Design Intended for Average Bioequivalence with Expanding Limits
| Autor: | Michael Tomashevskiy, Mario González-de la Parra, Helmut Schütz, Anastasia Shitova, Detlew Labes, Anders Fuglsang |
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| Rok vydání: | 2020 |
| Předmět: |
Clinical Trials as Topic
Computer science business.industry Software Validation Pharmacology toxicology Degrees of freedom Datasets as Topic Reproducibility of Results Pharmaceutical Science Replicate Bioequivalence computer.software_genre Public domain 030226 pharmacology & pharmacy Data Accuracy 03 medical and health sciences 0302 clinical medicine Software Therapeutic Equivalency Research Design 030220 oncology & carcinogenesis Humans Data mining business computer |
| Zdroj: | The AAPS Journal. 22 |
| ISSN: | 1550-7416 |
| DOI: | 10.1208/s12248-020-0427-6 |
| Popis: | In order to help companies qualify and validate the software used to evaluate bioequivalence trials in a replicate design intended for average bioequivalence with expanding limits, this work aims to define datasets with known results. This paper releases 30 reference datasets into the public domain along with proposed consensus results. A proposal is made for results that should be used as validation targets. The datasets were evaluated by seven different software packages according to methods proposed by the European Medicines Agency. For the estimation of CVwR and Method A, all software packages produced results that are in agreement across all datasets. Due to different approximations of the degrees of freedom, slight differences were observed in two software packages for Method B in highly incomplete datasets. All software packages were suitable for the estimation of CVwR and Method A. For Method B, different methods for approximating the denominator degrees of freedom could lead to slight differences, which eventually could lead to contrary decisions in very rare borderline cases. |
| Databáze: | OpenAIRE |
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