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Bioanalysis
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November 12, 2014
Recommendations on incurred sample stability (ISS) by GCC
Steve Lowes, Richard LeLacheur, Ronald Shoup, et al.
Bioanalysis
|
October 24, 2012
Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
Robert Nicholson, Steve Lowes, Maria Cruz Caturla, et al.
Bioanalysis
|
November 22, 2014
7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing
Mario Rocci, Steve Lowes, Ronald Shoup, et al.
Bioanalysis
|
August 18, 2025
17th GCC Closed Forum: Integrative Bioanalysis, Patient-centric Sampling, Emerging Technologies, Data Integrity, Sample Reconciliation, Discrepancies of ELISpot Data, Cross-validation Harmonization, Ultrasensitive Platforms for ADA Assays, Remote Regulatory Assessments, Shedding Assays by PCR, and Biomarker Tissue Assays
Jennifer Zimmer, Mark O'dell, Derrick Johnson, et al.
Bioanalysis
|
June 15, 2022
Recommendations on qPCR/ddPCR assay validation by GCC
Mark Wissel, Martin Poirier, Christina Satterwhite, et al.
Bioanalysis
|
February 9, 2022
Recommendations on ELISpot assay validation by the GCC
Rafiq Islam, Jennifer Vance, Martin Poirier, et al.
Bioanalysis
|
February 27, 2016
9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks
Roger Hayes, Richard LeLacheur, Isabelle Dumont, et al.
Bioanalysis
|
April 18, 2019
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis
Rafiq Islam, Sumit Kar, Hanna Ritzén, et al.
Bioanalysis
|
October 1, 2019
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
Corey Nehls, Michael Buonarati, Stephanie Cape, et al.
Bioanalysis
|
December 16, 2014
8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation
Joseph Bower, Douglas Fast, Fabio Garofolo, et al.
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of 3
Search research articles
Search
Showing results (11-20 of 26) with videos related to
Sort By:
Page
of 3
Bioanalysis
|
November 12, 2014
Recommendations on incurred sample stability (ISS) by GCC
Steve Lowes, Richard LeLacheur, Ronald Shoup, et al.
Bioanalysis
|
October 24, 2012
Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
Robert Nicholson, Steve Lowes, Maria Cruz Caturla, et al.
Bioanalysis
|
November 22, 2014
7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing
Mario Rocci, Steve Lowes, Ronald Shoup, et al.
Bioanalysis
|
August 18, 2025
17th GCC Closed Forum: Integrative Bioanalysis, Patient-centric Sampling, Emerging Technologies, Data Integrity, Sample Reconciliation, Discrepancies of ELISpot Data, Cross-validation Harmonization, Ultrasensitive Platforms for ADA Assays, Remote Regulatory Assessments, Shedding Assays by PCR, and Biomarker Tissue Assays
Jennifer Zimmer, Mark O'dell, Derrick Johnson, et al.
Bioanalysis
|
June 15, 2022
Recommendations on qPCR/ddPCR assay validation by GCC
Mark Wissel, Martin Poirier, Christina Satterwhite, et al.
Bioanalysis
|
February 9, 2022
Recommendations on ELISpot assay validation by the GCC
Rafiq Islam, Jennifer Vance, Martin Poirier, et al.
Bioanalysis
|
February 27, 2016
9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks
Roger Hayes, Richard LeLacheur, Isabelle Dumont, et al.
Bioanalysis
|
April 18, 2019
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis
Rafiq Islam, Sumit Kar, Hanna Ritzén, et al.
Bioanalysis
|
October 1, 2019
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
Corey Nehls, Michael Buonarati, Stephanie Cape, et al.
Bioanalysis
|
December 16, 2014
8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation
Joseph Bower, Douglas Fast, Fabio Garofolo, et al.
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of 3