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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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| Main Authors: | , , , , , , , , |
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| Format: | Artigo |
| Language: | Inglês |
| Published: |
Springer US
2009
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| Subjects: | |
| Online Access: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2691460/ https://ncbi.nlm.nih.gov/pubmed/19381839 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-009-9100-9 |
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