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Bioanalysis
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October 17, 2019
Variations in internal standard: an inspector's perspective
Stephen Vinter
Bioanalysis
|
November 17, 2021
Conduct of remote inspections: challenges and progress
Jason Wakelin-Smith, Stephen Vinter
Bioanalysis
|
October 23, 2019
Crucial importance of evaluating internal standards (IS) response and troubleshooting in effective LCMS method development, validation and sample analysis
Seongeun Julia Cho, Stephen Vinter, Fabio Garofolo
Clinical Pharmacology and Therapeutics
|
January 21, 2020
Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop
Ni A Khin, Gail Francis, Jean Mulinde, et al.
Clinical Pharmacology and Therapeutics
|
August 6, 2021
Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK
Ni A Khin, Cheryl Grandinetti, Hayley Dixey, et al.
Bioanalysis
|
December 3, 2015
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies)
Brad Ackermann, Hendrik Neubert, Nicola Hughes, et al.
Bioanalysis
|
November 18, 2015
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS)
Jan Welink, Eric Fluhler, Nicola Hughes, et al.
Bioanalysis
|
November 19, 2016
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies)
An Song, Anita Lee, Fabio Garofolo, 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.
Page
of 2
Search research articles
Search
Showing results (1-10 of 18) with videos related to
Sort By:
Page
of 2
Bioanalysis
|
October 17, 2019
Variations in internal standard: an inspector's perspective
Stephen Vinter
Bioanalysis
|
November 17, 2021
Conduct of remote inspections: challenges and progress
Jason Wakelin-Smith, Stephen Vinter
Bioanalysis
|
October 23, 2019
Crucial importance of evaluating internal standards (IS) response and troubleshooting in effective LCMS method development, validation and sample analysis
Seongeun Julia Cho, Stephen Vinter, Fabio Garofolo
Clinical Pharmacology and Therapeutics
|
January 21, 2020
Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop
Ni A Khin, Gail Francis, Jean Mulinde, et al.
Clinical Pharmacology and Therapeutics
|
August 6, 2021
Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK
Ni A Khin, Cheryl Grandinetti, Hayley Dixey, et al.
Bioanalysis
|
December 3, 2015
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies)
Brad Ackermann, Hendrik Neubert, Nicola Hughes, et al.
Bioanalysis
|
November 18, 2015
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS)
Jan Welink, Eric Fluhler, Nicola Hughes, et al.
Bioanalysis
|
November 19, 2016
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies)
An Song, Anita Lee, Fabio Garofolo, 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.
Page
of 2