Publications by authors named "Mathilde Yu"

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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, Amanda Hays, Shashank Gorityala, Moucun Yuan, Mathilde Yu

Bioanalysis· June 2025

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Recommendations on biomarker assay validation (BAV) in tissues by GCC.
Moucun Yuan, Aihua Liu, Bin Xu, Kurt Sales, Shane Karnik, Mathilde Yu

Bioanalysis· April 2025

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Recommendations on qPCR/ddPCR assay validation by GCC.
Mark Wissel, Martin Poirier, Christina Satterwhite, John Lin, Rafiq Islam, Mathilde Yu, Moucun Yuan

Bioanalysis· June 2022

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Recommendations on ELISpot assay validation by the GCC.
Rafiq Islam, Jennifer Vance, Martin Poirier, Jennifer Zimmer, Ardeshir Khadang, Mathilde Yu, Moucun Yuan

Bioanalysis· February 2022

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12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
Chad Briscoe, Nicola Hughes, Roger Hayes, Rafiq Islam, Patrick Bennett, Mathilde Yu

Bioanalysis· June 2019

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Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.
Rafiq Islam, Sumit Kar, Hanna Ritzén, Amanda Hays, Rabab Tayyem, Mathilde Yu

Bioanalysis· April 2019

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11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.
Rafiq Islam, Chad Briscoe, Joseph Bower, Stephanie Cape, Mark Arnold, Mathilde Yu

Bioanalysis· April 2018

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The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.
Stephanie Cape, Rafiq Islam, Corey Nehls, John Allinson, Afshin Safavi, Mathilde Yu

Bioanalysis· April 2017

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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, Philippe Couerbe, Afshin Safavi, Mathilde Yu

Bioanalysis· March 2016

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8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.
Joseph Bower, Douglas Fast, Fabio Garofolo, Dominique Gouty, Roger Hayes, Mathilde Yu

Bioanalysis· July 2015

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Targeting soluble Abeta peptide with Tramiprosate for the treatment of brain amyloidosis.
Francine Gervais, Julie Paquette, Céline Morissette, Pascale Krzywkowski, Mathilde Yu

Neurobiol Aging· April 2007

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Mapping genetic modulators of amyloid plaque deposition in TgCRND8 transgenic mice.
Giovanna Sebastiani, Pascale Krzywkowski, Sherri Dudal, Mathilde Yu, Julie Paquette

Hum Mol Genet· August 2006

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