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Roger Hayes

Showing results (21-30 of 34) with videos related to

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Bioanalysis|October 24, 2012
Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilarsRobert Nicholson, Steve Lowes, Maria Cruz Caturla, et al.
Bioanalysis|February 9, 2022
Recommendations on ELISpot assay validation by the GCCRafiq Islam, Jennifer Vance, Martin Poirier, 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|December 14, 2019
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (<u>Part 2</u> - 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, et al.
Bioanalysis|October 11, 2013
2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMSLauren Stevenson, Fabio Garofolo, Binodh DeSilva, 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 notebooksRoger Hayes, Richard LeLacheur, Isabelle Dumont, et al.
Bioanalysis|July 20, 2019
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicityChad Briscoe, Nicola Hughes, Roger Hayes, et al.
Bioanalysis|April 18, 2019
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysisRafiq 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 GuidelineCorey 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 validationJoseph Bower, Douglas Fast, Fabio Garofolo, et al.
Pageof 4

Showing results (21-30 of 34) with videos related to

Sort By:
Pageof 4
Bioanalysis|October 24, 2012
Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilarsRobert Nicholson, Steve Lowes, Maria Cruz Caturla, et al.
Bioanalysis|February 9, 2022
Recommendations on ELISpot assay validation by the GCCRafiq Islam, Jennifer Vance, Martin Poirier, 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|December 14, 2019
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (<u>Part 2</u> - 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, et al.
Bioanalysis|October 11, 2013
2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMSLauren Stevenson, Fabio Garofolo, Binodh DeSilva, 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 notebooksRoger Hayes, Richard LeLacheur, Isabelle Dumont, et al.
Bioanalysis|July 20, 2019
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicityChad Briscoe, Nicola Hughes, Roger Hayes, et al.
Bioanalysis|April 18, 2019
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysisRafiq 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 GuidelineCorey 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 validationJoseph Bower, Douglas Fast, Fabio Garofolo, et al.
Pageof 4