Search research articles
Contact Us
Filters
Showing results (21-30 of 34) with videos related to
Page
of 4
Sort By:
Bioanalysis
|
October 24, 2012
Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
Robert Nicholson, Steve Lowes, Maria Cruz Caturla, et al.
Bioanalysis
|
February 9, 2022
Recommendations on ELISpot assay validation by the GCC
Rafiq 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 LCMS
Lauren 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 notebooks
Roger 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 immunogenicity
Chad 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 bioanalysis
Rafiq 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 Guideline
Corey 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 validation
Joseph Bower, Douglas Fast, Fabio Garofolo, et al.
Page
of 4
Search research articles
Search
Showing results (21-30 of 34) with videos related to
Sort By:
Page
of 4
Bioanalysis
|
October 24, 2012
Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
Robert Nicholson, Steve Lowes, Maria Cruz Caturla, et al.
Bioanalysis
|
February 9, 2022
Recommendations on ELISpot assay validation by the GCC
Rafiq 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 LCMS
Lauren 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 notebooks
Roger 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 immunogenicity
Chad 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 bioanalysis
Rafiq 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 Guideline
Corey 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 validation
Joseph Bower, Douglas Fast, Fabio Garofolo, et al.
Page
of 4