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Bioanalysis
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June 18, 2011
Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis
Steve Lowes, Jim Jersey, Ronald Shoup, et al.
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.
The AAPS Journal
|
July 8, 2023
Neutralizing Antibody Validation Testing and Reporting Harmonization
Heather Myler, João Pedras-Vasconcelos, Todd Lester, 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
|
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.
Bioanalysis
|
March 29, 2012
Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
Mark Boterman, Mira Doig, Massimo Breda, et al.
Bioanalysis
|
April 28, 2018
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, et al.
Page
of 6
Search research articles
Search
Showing results (41-50 of 51) with videos related to
Sort By:
Page
of 6
Bioanalysis
|
June 18, 2011
Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis
Steve Lowes, Jim Jersey, Ronald Shoup, et al.
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.
The AAPS Journal
|
July 8, 2023
Neutralizing Antibody Validation Testing and Reporting Harmonization
Heather Myler, João Pedras-Vasconcelos, Todd Lester, 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
|
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.
Bioanalysis
|
March 29, 2012
Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
Mark Boterman, Mira Doig, Massimo Breda, et al.
Bioanalysis
|
April 28, 2018
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, et al.
Page
of 6