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PMID: 42533676 已发表 · ppublish 英语

18th GCC Closed Forum: Compliance with FDA Biomarkers Guidance, Novel ELN/LIMS Platforms, Sample Reconciliation, Emerging Technologies, Improvements in ELISpot, Post-extraction Sample Stability, LBA Singlicate, Regulatory Inspections, Chicken anti-Human IgG, Cross-validation Harmonization.

Bioanalysis ·第 18 卷 ·第 8-9 期

Karnik S, Zimmer J, Gutekunst M, Gorityala S, Goodman J, Jerks E, Litwin V, Tang X, Leskovar A, Tary-Lehmann M, Lowes S, Lavelle A, Yuan M, Liu A, O'Brien K, Dong K, Sales K, Reuschel S, Keyhani A, Johnson D, Odell M, Abdeen SJ, Hays A, Beyerlein D, Johnson M, Yu M, Cotton S, Joyce P, Fang WWT, Garofolo W, Nadarajah S, Spytko A, Dufield D, Rutherford L, Pankratz T, Xu A, Sikkema D, Hyer E, Iles T, Bonner E, Dimarco C, Hristopoulos G, Patterson K, Nash B, Bretton V, Rocha A, Satterwhite C, Yamashita J, McNally J, Fang X, Fan L

摘要

The 18th GCC Closed Forum was held in New Orleans, LA, USA, on 11 April 2025. Representatives from international bioanalytical Contract Research Organizations were in attendance to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: Compliance with US FDA Guidance for Biomarkers; Emerging Technologies; Sample Reconciliation Efforts; Chicken anti-Human IgG antibody; Post-extraction Sample Stability; Singlicate for LBA; Discrepancies of ELISpot data; Regulatory Inspection Experiences; Cross-validation Harmonization in Regulated Bioanalysis; and ELN/LIMS. Conclusions and consensus from discussions of these topics are included in this article.

关键词
Bioanalysis Biomarkers CRO Cross-validation ELISpot GCC Global CRO Council Regulated Bioanalysis Sample reconciliation Stability
文献信息
期刊
Bioanalysis
期刊简称
Bioanalysis
ISSN
1757-6199
语言
英语
国家/地区
England
NLM ID
101512484
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