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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Bibliographic Details
Main Authors: Fast, Douglas M., Kelley, Marian, Viswanathan, C. T., O’Shaughnessy, Jacqueline, King, S. Peter, Chaudhary, Ajai, Weiner, Russell, DeStefano, Anthony J., Tang, Daniel
Format: Artigo
Language:Inglês
Published: Springer US 2009
Subjects:
Meeting Report
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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