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Bioanalysis
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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
|
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.
Page
of 3
Search research articles
Search
Showing results (21-30 of 25) with videos related to
Sort By:
Page
of 3
You have reached the last page of results.
This site can display upto 25 results.
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
|
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.
Page
of 3