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  • Statistična analiza raziskav bioekvivalence v programskem okolju R = Statistical analysis of bioequivalence studies in R software environment : magistrska naloga : enoviti magistrski študijski program Farmacija
    Krajnc, Tajda, 1993-
    R is an open-source programming language and software environment that is predominantly used for graphics and statistical computing. All code is openly accessible which means that validation of ... internal structures in addition to functionality is possible. In this thesis we examined the use of R software environment and available packages in bioequivalence data analysis. Bioequivalence is an important concept in medicine approval, allowing bridging of preclinical tests and clinical trials, which enables the medicine to reach the market sooner and at lower cost. Evaluation of data obtained in a bioequivalence study must be performed with validated software. We wrote code for statistical analysis of a single dose crossover design and a full replicate design bioequivalence study in R. We used the package »NonCompart« for noncompartmental analysis, »BE« for the statistical analysis of a single dose crossover design and »replicateBE« for the statistical analysis of a full replicate design study. We validated our code by using it to analyze public access data and comparing our results with those produced by independent validated software. There were no differences between the results produced by our code in comparison with those produced by validated software. We further demonstrated the use of R in bioequivalence analysis by using our code to analyze two inhouse datasets, a single dose crossover and a full replicate design study. We found that in both studies the test formulation was not bioequivalent to the reference formulation. An opportunity to build on our work would be to develop our own code and packages and analyze the data without using already existing packages. For future studies performing “white-box” validation of R as software to perform statistical analysis would be interesting. That is to perform validation of its internal structures, not only of the functionality.
    Vrsta gradiva - magistrsko delo ; neleposlovje za odrasle
    Založništvo in izdelava - Ljubljana : [T. Krajnc], 2022
    Jezik - angleški
    COBISS.SI-ID - 135024387

Knjižnica/institucija Kraj Akronim Za izposojo Druga zaloga
Fakulteta za farmacijo, Ljubljana Ljubljana FFALJ v čitalnico 1 izv.
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