Best practices for metabolite quantification in drug development: updated recommendation from the European Bioanalysis Forum
| Autor: | Philip Timmerman, Martha Green, Stephen White, Claude Delatour, Stefan Blech, John Smeraglia, Stuart McDougall, Geert Mannens, Graeme Young, Stephen Alaric Williams |
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| Rok vydání: | 2016 |
| Předmět: |
Bioanalysis
Process management Drug-Related Side Effects and Adverse Reactions Best practice Metabolite Clinical Biochemistry Pharmacology 030226 pharmacology & pharmacy 01 natural sciences Analytical Chemistry 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Drug Discovery Animals Humans Metabolomics Medicine General Pharmacology Toxicology and Pharmaceutics Safety testing business.industry 010401 analytical chemistry General Medicine Tiered approach 0104 chemical sciences Europe Medical Laboratory Technology Pharmaceutical Preparations Drug development chemistry business |
| Zdroj: | Bioanalysis. 8:1297-1305 |
| ISSN: | 1757-6199 1757-6180 |
| DOI: | 10.4155/bio-2016-0103 |
| Popis: | Metabolite quantification and profiling continues to grow in importance in today's drug development. The guidance provided by the 2008 FDA Metabolites in Safety Testing Guidance and the subsequent ICH M3(R2) Guidance (2009) has led to a more streamlined process to assess metabolite exposures in preclinical and clinical studies in industry. In addition, the European Bioanalysis Forum (EBF) identified an opportunity to refine the strategies on metabolite quantification considering the experience to date with their recommendation paper on the subject dating from 2010 and integrating the recent discussions on the tiered approach to bioanalytical method validation with focus on metabolite quantification. The current manuscript summarizes the discussion and recommendations from a recent EBF Focus Workshop into an updated recommendation for metabolite quantification in drug development. |
| Databáze: | OpenAIRE |
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