Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations
The Conference Report of the 3rd AAPS/FDA Bioanalytical Workshop (Crystal City III) endorsed the concept that assay methods supporting bioanalytical data in submissions must demonstrate assay reproducibility by using incurred samples. The present Workshop was convened to provide a forum for discussi...
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| Veröffentlicht in: | The AAPS journal 2009-06, Vol.11 (2), p.238-241 |
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| container_title | The AAPS journal |
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| creator | Fast, Douglas M. Kelley, Marian Viswanathan, C. T. O’Shaughnessy, Jacqueline King, S. Peter Chaudhary, Ajai Weiner, Russell DeStefano, Anthony J. Tang, Daniel |
| description | The Conference Report of the 3rd AAPS/FDA Bioanalytical Workshop (Crystal City III) endorsed the concept that assay methods supporting bioanalytical data in submissions must demonstrate assay reproducibility by using incurred samples. The present Workshop was convened to provide a forum for discussion and consensus building about incurred sample assay reproducibility for both nonclinical and clinical studies. Information about current regulatory perspectives on incurred sample reanalysis (ISR) was presented, implications of ISR for both large and small molecules were discussed, and the steering committee put forth recommendations for performing ISR. These recommendations from the Workshop, along with the subsequent evolution of approaches leading to a robust ISR program, may be used by scientists performing bioanalytical assays for regulated studies to provide additional confirmation of assay reproducibility for incurred samples. |
| doi_str_mv | 10.1208/s12248-009-9100-9 |
| format | Article |
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| ispartof | The AAPS journal, 2009-06, Vol.11 (2), p.238-241 |
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| source | MEDLINE; Springer Nature - Complete Springer Journals; PubMed Central |
| subjects | Analytic Sample Preparation Methods Animals Biochemistry Biological Assay - standards Biomedical and Life Sciences Biomedicine Biotechnology Guidelines as Topic Humans Meeting Report Pharmaceutical Preparations - analysis Pharmaceutical Preparations - metabolism Pharmacokinetics Pharmacology/Toxicology Pharmacy Reproducibility of Results |
| title | Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations |
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