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Bioanalysis
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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.
Bioanalysis
|
April 18, 2025
Recommendations on biomarker assay validation (BAV) in tissues by GCC
Moucun Yuan, Aihua Liu, Bin Xu, 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
|
March 25, 2017
The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud
Stephanie Cape, Rafiq Islam, Corey Nehls, 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.
Annals of the Rheumatic Diseases
|
September 29, 2019
Emergent high fatality lung disease in systemic juvenile arthritis
Vivian E Saper, Guangbo Chen, Gail H Deutsch, et al.
Page
of 9
Search research articles
Search
Showing results (71-80 of 81) with videos related to
Sort By:
Page
of 9
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.
Bioanalysis
|
April 18, 2025
Recommendations on biomarker assay validation (BAV) in tissues by GCC
Moucun Yuan, Aihua Liu, Bin Xu, 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
|
March 25, 2017
The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud
Stephanie Cape, Rafiq Islam, Corey Nehls, 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.
Annals of the Rheumatic Diseases
|
September 29, 2019
Emergent high fatality lung disease in systemic juvenile arthritis
Vivian E Saper, Guangbo Chen, Gail H Deutsch, et al.
Page
of 9