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Bioanalysis
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September 27, 2019
Contract research organization commentary on the importance of harmonization and the impact of ICH M10
Chad Briscoe, Corey Nehls, Mike Buonarati, et al.
Bioanalysis
|
April 13, 2021
Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis
Joseph Bower, Jennifer Zimmer, Stacie McCown, et al.
Bioanalysis
|
June 15, 2022
Recommendations on qPCR/ddPCR assay validation by GCC
Mark Wissel, Martin Poirier, Christina Satterwhite, et al.
Bioanalysis
|
February 9, 2022
Recommendations on ELISpot assay validation by the GCC
Rafiq Islam, Jennifer Vance, Martin Poirier, 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
|
November 19, 2016
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity)
Susan Richards, Lakshmi Amaravadi, Renuka Pillutla, 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.
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of 2
Search research articles
Search
Showing results (1-10 of 13) with videos related to
Sort By:
Page
of 2
Bioanalysis
|
September 27, 2019
Contract research organization commentary on the importance of harmonization and the impact of ICH M10
Chad Briscoe, Corey Nehls, Mike Buonarati, et al.
Bioanalysis
|
April 13, 2021
Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis
Joseph Bower, Jennifer Zimmer, Stacie McCown, et al.
Bioanalysis
|
June 15, 2022
Recommendations on qPCR/ddPCR assay validation by GCC
Mark Wissel, Martin Poirier, Christina Satterwhite, et al.
Bioanalysis
|
February 9, 2022
Recommendations on ELISpot assay validation by the GCC
Rafiq Islam, Jennifer Vance, Martin Poirier, 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
|
November 19, 2016
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity)
Susan Richards, Lakshmi Amaravadi, Renuka Pillutla, 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.
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of 2