Recommendations on qPCR/ddPCR Assay Validation by GCC
Mark Wissel, Martin Poirier, Christina Satterwhite, John Lin et autres
us, ca (code pays fourni par la source)
51 citations
Bioanalysis
Christina Satterwhite
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26Publications signalées
556Citations signalées
1Affiliations récentes
Les institutions déclarées
Les domaines associés
Biosimilars and Bioanalytical MethodsClinical Laboratory Practices and Quality ControlBiosensors and Analytical DetectionIon channel regulation and functionMonoclonal and Polyclonal Antibodies Research
Les publications récentes
Recommendations on ELISpot Assay Validation by the GCC
Rafiq Islam, Jennifer Vance, Martin Poirier, Jennifer Zimmer et autres
us, ca, cn (code pays fourni par la source)
15 citations
Bioanalysis
Special Techniques in Toxicologic Pathology
Shari A. Price, Kevin S. McDorman, Curtis M. Chan, Jennifer L. Rojko et autres
us (code pays fourni par la source)
2 citations
Elsevier eBooks
Contributors
Rick R. Adler, Famke Aeffner, Laura E. Armstrong, Dmitri Artemov et autres
us, gb (code pays fourni par la source)
0 citations
Elsevier eBooks
Recommendations for the Content and Management of Certificates of Analysis for Reference Standards from the GCC for Bioanalysis
Joseph Bower, Jennifer Zimmer, Stacie McCown, Edward Tabler et autres
us, ca, cn (code pays fourni par la source)
10 citations
Bioanalysis
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( Part 2A –Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B –Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)
Susan Spitz, Yan Zhang, Sally Fischer, Kristina McGuire et autres
us, ch, de, gb, ca, br, no (code pays fourni par la source)
27 citations
Bioanalysis
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)
Brian Booth, Lauren Stevenson, Renuka Pillutla, Michael H. Buonarati et autres
us, ch, it, fr, br, ca, gb, no (code pays fourni par la source)
32 citations
Bioanalysis
Contract Research Organization Commentary on the Importance of Harmonization and the Impact of ICH M10
Chad Briscoe, Corey Nehls, Mike Buonarati, Stephanie Cape et autres
us, ca (code pays fourni par la source)
1 citation
Bioanalysis
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
Corey Nehls, Michael H. Buonarati, Stephanie Cape, Rafiq Islam et autres
us, ie, se, ca, de, gb, nl, si, cl, ch, in, cn (code pays fourni par la source)
30 citations
Bioanalysis
12th GCC Closed Forum: Critical Reagents; Oligonucleotides; CoA; Method Transfer; HRMS; Flow Cytometry; Regulatory Findings; Stability and Immunogenicity
Chad Briscoe, Nicola Hughes, Rafiq Islam, Patrick Bennett et autres
us, ca, ch, es, fr, ee, si, gb, au, se, ro (code pays fourni par la source)
14 citations
Bioanalysis
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 et autres
us, ca, gb (code pays fourni par la source)
15 citations
Bioanalysis
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 et autres
us, ca (code pays fourni par la source)
16 citations
Bioanalysis
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