Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays
| Autor: | Mark J. Rose, Vinod P. Shah, Jeffrey Sailstad, C. T. Viswanathan, Jerome P. Skelly, Brian Booth, Patrick G. Swann, Surendra Bansal, Russell Weiner, Anthony J. Destefano |
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| Rok vydání: | 2007 |
| Předmět: |
Quality Control
Macromolecular Substances Computer science Best practice Pharmacology toxicology Pharmaceutical Science Guidelines as Topic Documentation Radioligand Assay Drug Stability Species Specificity Government regulation Lc ms ms Animals Humans Technology Pharmaceutical Pharmacology (medical) Reference standards Pharmacology Chromatography United States Food and Drug Administration Organic Chemistry Reproducibility of Results Reference Standards United States Body Fluids Calibration Government Regulation Molecular Medicine Biological Assay Artifacts Biotechnology |
| Zdroj: | Pharmaceutical Research. 24:1962-1973 |
| ISSN: | 1573-904X 0724-8741 |
| Popis: | The Third AAPS/FDA Bioanalytical Workshop, entitled "Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays" was held on May 1-3, 2006 in Arlington, VA. The format of this workshop consisted of presentations on bioanalytical topics, followed by discussion sessions where these topics could be debated, with the goal of reaching consensus, or identifying subjects where addition input or clarification was required. The discussion also addressed bioanalytical validation requirements of regulatory agencies, with the purpose of clarifying expectations for regulatory submissions. The proceedings from each day were reviewed and summarized in the evening sessions among the speakers and moderators of the day. The consensus summary was presented back to the workshop on the last day and was further debated. This communication represents the distillate of the workshop proceedings and provides the summary of consensus reached and also contains the validation topics where no consensus was reached. |
| Databáze: | OpenAIRE |
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