Co-medication and interference testing in bioanalysis: a European Bioanalysis Forum recommendation
| Autor: | Philip Timmerman, Marianne Scheel-Fjording, Bruno Le Bras, Alberto Guenzi, Stephen White, Daniel Neddermann, Berthold Lausecker, Susanne Globig, Marcel de Zwart |
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| Rok vydání: | 2016 |
| Předmět: |
Quality Control
medicine.medical_specialty Bioanalysis Computer science Clinical Biochemistry Nanotechnology Ligands 030226 pharmacology & pharmacy 01 natural sciences Analytical Chemistry 03 medical and health sciences 0302 clinical medicine Interference (communication) Tandem Mass Spectrometry medicine Humans Medical physics In patient Drug Interactions General Pharmacology Toxicology and Pharmaceutics Chromatography High Pressure Liquid 010401 analytical chemistry General Medicine PK Parameters 0104 chemical sciences Medical Laboratory Technology Pharmaceutical Preparations Co medication |
| Zdroj: | Bioanalysis. 8(19) |
| ISSN: | 1757-6199 |
| Popis: | Interference testing of co-medication in bioanalytical method validation has become an area of debate in view of the increased specificity offered by current state-of-the-art technology in both LC–MS/MS and ligand-binding assay platforms. In view of this, and considering the extensive experience within the European Bioanalysis Forum member companies, we evaluated the impact of co-medication on the performance of hundreds of bioanalytical methods with the aim of providing a science-based recommendation on how to evaluate and document potential interference from co-medication on the PK parameters in clinical studies in patients and volunteers. |
| Databáze: | OpenAIRE |
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