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Rafiq Islam

Showing results (41-50 of 51) with videos related to

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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|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 notebooksRoger 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 immunogenicityChad 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 bioanalysisRafiq 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 GuidelineCorey Nehls, Michael Buonarati, Stephanie Cape, 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 fraudStephanie 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 validationRafiq Islam, Chad Briscoe, Joseph Bower, et al.
Bioanalysis|December 6, 2017
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays)Shalini Gupta, Susan Richards, Lakshmi Amaravadi, et al.
Bioanalysis|November 30, 2018
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays)Lauren Stevenson, Susan Richards, Renuka Pillutla, et al.
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Showing results (41-50 of 51) with videos related to

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Pageof 6
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|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 notebooksRoger 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 immunogenicityChad 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 bioanalysisRafiq 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 GuidelineCorey Nehls, Michael Buonarati, Stephanie Cape, 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 fraudStephanie 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 validationRafiq Islam, Chad Briscoe, Joseph Bower, et al.
Bioanalysis|December 6, 2017
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays)Shalini Gupta, Susan Richards, Lakshmi Amaravadi, et al.
Bioanalysis|November 30, 2018
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays)Lauren Stevenson, Susan Richards, Renuka Pillutla, et al.
Pageof 6