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Article
Open AccessCurrent status of the analytical validation of next generation sequencing applications for pharmacogenetic profiling
Analytical validity is a prerequisite to use a next generation sequencing (NGS)-based application as an in vitro diagnostic test or a companion diagnostic in clinical practice. Currently, in the United States ...
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Article
Open AccessEvaluation of the EMPAR study population on the basis of metabolic phenotypes of selected pharmacogenes
The impact of genetic variability of pharmacogenes as a possible risk factor for adverse drug reactions is elucidated in the EMPAR (Einfluss metabolischer Profile auf die Arzneimitteltherapiesicherheit in der ...
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Article
Open AccessMolecular Genetic Techniques in Biomarker Analysis Relevant for Drugs Centrally Approved in Europe
On the basis of scientific evidence, information on the option, recommendation or requirement to test for pharmacogenetic or pharmacogenomic biomarkers is incorporated in the Summary of Product Characteristics...
