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Bioanalysis
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November 14, 2024
Harmonization of Vaccine Ligand Binding Assays Validation
Francis Dessy, Ivo Sonderegger, Leslie Wagner, et al.
Bioanalysis
|
February 9, 2022
Recommendations on ELISpot assay validation by the GCC
Rafiq Islam, Jennifer Vance, Martin Poirier, et al.
Bioanalysis
|
November 30, 2018
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity)
Hendrik Neubert, Timothy Olah, Anita Lee, et al.
Bioanalysis
|
November 18, 2017
2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers)
Jan Welink, Eric Yang, Nicola Hughes, et al.
Bioanalysis
|
December 5, 2015
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity)
Lakshmi Amaravadi, An Song, Heather Myler, et al.
Bioanalysis
|
December 6, 2017
2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs)
Hendrik Neubert, An Song, Anita Lee, et al.
Bioanalysis
|
December 23, 2014
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input)
Dawn Dufield, Hendrik Neubert, Fabio Garofolo, et al.
Bioanalysis
|
February 3, 2021
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (<u>Part 3</u> - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)
Bart Corsaro, Tong-Yuan Yang, Rocio Murphy, et al.
Bioanalysis
|
January 20, 2021
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (<u>Part 1</u> - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)
Hendrik Neubert, Stephen C Alley, Anita Lee, et al.
Bioanalysis
|
November 30, 2018
2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis)
Jan Welink, Yuanxin Xu, Eric Yang, et al.
Page
of 12
Search research articles
Search
Showing results (81-90 of 115) with videos related to
Sort By:
Page
of 12
Bioanalysis
|
November 14, 2024
Harmonization of Vaccine Ligand Binding Assays Validation
Francis Dessy, Ivo Sonderegger, Leslie Wagner, et al.
Bioanalysis
|
February 9, 2022
Recommendations on ELISpot assay validation by the GCC
Rafiq Islam, Jennifer Vance, Martin Poirier, et al.
Bioanalysis
|
November 30, 2018
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity)
Hendrik Neubert, Timothy Olah, Anita Lee, et al.
Bioanalysis
|
November 18, 2017
2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers)
Jan Welink, Eric Yang, Nicola Hughes, et al.
Bioanalysis
|
December 5, 2015
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity)
Lakshmi Amaravadi, An Song, Heather Myler, et al.
Bioanalysis
|
December 6, 2017
2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs)
Hendrik Neubert, An Song, Anita Lee, et al.
Bioanalysis
|
December 23, 2014
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input)
Dawn Dufield, Hendrik Neubert, Fabio Garofolo, et al.
Bioanalysis
|
February 3, 2021
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (<u>Part 3</u> - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)
Bart Corsaro, Tong-Yuan Yang, Rocio Murphy, et al.
Bioanalysis
|
January 20, 2021
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (<u>Part 1</u> - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)
Hendrik Neubert, Stephen C Alley, Anita Lee, et al.
Bioanalysis
|
November 30, 2018
2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis)
Jan Welink, Yuanxin Xu, Eric Yang, et al.
Page
of 12