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DOI 10.1080/17576180.2026.2696193

Медицинская библиотека · Bioanalysis · 2026

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.

Karnik Shane, Zimmer Jennifer, Gutekunst Matthias, Gorityala Shashank, Goodman Jo, Jerks Erik, Litwin Virginia, Tang Xiaonan, Leskovar Amanda, Tary-Lehmann Magdalena, Lowes Stephen, Lavelle Amy, Yuan Moucun, Liu Aihua, O'Brien Kyla, Dong Kelly, Sales Kurt, Reuschel Scott, Keyhani Anahita, Johnson Derrick, Odell Mark, Abdeen Sanofar Jainul, Hays Amanda, Beyerlein Dave, Johnson Michael, Yu Mathilde, Cotton Sophie, Joyce Philip, Fang Wendy W T, Garofolo Wei, Nadarajah Sankeetha, Spytko Adriane, Dufield Dawn, Rutherford Lindsay, Pankratz Todd, Xu Allan, Sikkema Daniel, Hyer Elizabeth, Iles Tracy, Bonner Eric, Dimarco Chantal, Hristopoulos Georgios, Patterson Kate, Nash Brad, Bretton Vera, Rocha Agostinho, Satterwhite Christina, Yamashita Jim, McNally Jim, Fang Xinping, Fan Leimin

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Аннотация

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.

Для цитирования: Karnik Shane, Zimmer Jennifer, Gutekunst Matthias, Gorityala Shashank, Goodman Jo, Jerks Erik, Litwin Virginia, Tang Xiaonan, Leskovar Amanda, Tary-Lehmann Magdalena, Lowes Stephen, Lavelle Amy, Yuan Moucun, Liu Aihua, O'Brien Kyla, Dong Kelly, Sales Kurt, Reuschel Scott, Keyhani Anahita, Johnson Derrick, Odell Mark, Abdeen Sanofar Jainul, Hays Amanda, Beyerlein Dave, Johnson Michael, Yu Mathilde, Cotton Sophie, Joyce Philip, Fang Wendy W T, Garofolo Wei, Nadarajah Sankeetha, Spytko Adriane, Dufield Dawn, Rutherford Lindsay, Pankratz Todd, Xu Allan, Sikkema Daniel, Hyer Elizabeth, Iles Tracy, Bonner Eric, Dimarco Chantal, Hristopoulos Georgios, Patterson Kate, Nash Brad, Bretton Vera, Rocha Agostinho, Satterwhite Christina, Yamashita Jim, McNally Jim, Fang Xinping, Fan Leimin. 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. 2026. DOI: 10.1080/17576180.2026.2696193.

Предметные рубрики MeSH

HumansAnimalsUnited States Food and Drug AdministrationBiomarkersUnited StatesChickensImmunoglobulin GEnzyme-Linked Immunospot Assay
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