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The AAPS Journal
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February 5, 2024
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development
Amanda Hays, Mark Wissel, Kelly Colletti, et al.
The AAPS Journal
|
September 4, 2024
Correction to: Neutralizing Antibody Sample Testing and Report Harmonization
Darshana Jani, Michele Gunsior, Robin Marsden, et al.
The AAPS Journal
|
July 11, 2024
Neutralizing Antibody Sample Testing and Report Harmonization
Darshana Jani, Michele Gunsior, Robin Marsden, 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 12, 2024
16<sup>th</sup> GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status
Jennifer Zimmer, Amanda Hays, Todd Lester, et al.
Bioanalysis
|
June 15, 2022
Recommendations on qPCR/ddPCR assay validation by GCC
Mark Wissel, Martin Poirier, Christina Satterwhite, et al.
The AAPS Journal
|
September 19, 2025
Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCR
Jason Pennucci, Amanda Hays, Wendy Adamowicz, et al.
Bioanalysis
|
August 18, 2025
17th GCC Closed Forum: Integrative Bioanalysis, Patient-centric Sampling, Emerging Technologies, Data Integrity, Sample Reconciliation, Discrepancies of ELISpot Data, Cross-validation Harmonization, Ultrasensitive Platforms for ADA Assays, Remote Regulatory Assessments, Shedding Assays by PCR, and Biomarker Tissue Assays
Jennifer Zimmer, Mark O'dell, Derrick Johnson, et al.
The AAPS Journal
|
October 28, 2022
Anti-drug Antibody Sample Testing and Reporting Harmonization
Darshana Jani, Robin Marsden, Michele Gunsior, et al.
Bioanalysis
|
February 9, 2022
Recommendations on ELISpot assay validation by the GCC
Rafiq Islam, Jennifer Vance, Martin Poirier, et al.
Page
of 4
Search research articles
Search
Showing results (21-30 of 35) with videos related to
Sort By:
Page
of 4
The AAPS Journal
|
February 5, 2024
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development
Amanda Hays, Mark Wissel, Kelly Colletti, et al.
The AAPS Journal
|
September 4, 2024
Correction to: Neutralizing Antibody Sample Testing and Report Harmonization
Darshana Jani, Michele Gunsior, Robin Marsden, et al.
The AAPS Journal
|
July 11, 2024
Neutralizing Antibody Sample Testing and Report Harmonization
Darshana Jani, Michele Gunsior, Robin Marsden, 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 12, 2024
16<sup>th</sup> GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status
Jennifer Zimmer, Amanda Hays, Todd Lester, et al.
Bioanalysis
|
June 15, 2022
Recommendations on qPCR/ddPCR assay validation by GCC
Mark Wissel, Martin Poirier, Christina Satterwhite, et al.
The AAPS Journal
|
September 19, 2025
Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCR
Jason Pennucci, Amanda Hays, Wendy Adamowicz, et al.
Bioanalysis
|
August 18, 2025
17th GCC Closed Forum: Integrative Bioanalysis, Patient-centric Sampling, Emerging Technologies, Data Integrity, Sample Reconciliation, Discrepancies of ELISpot Data, Cross-validation Harmonization, Ultrasensitive Platforms for ADA Assays, Remote Regulatory Assessments, Shedding Assays by PCR, and Biomarker Tissue Assays
Jennifer Zimmer, Mark O'dell, Derrick Johnson, et al.
The AAPS Journal
|
October 28, 2022
Anti-drug Antibody Sample Testing and Reporting Harmonization
Darshana Jani, Robin Marsden, Michele Gunsior, et al.
Bioanalysis
|
February 9, 2022
Recommendations on ELISpot assay validation by the GCC
Rafiq Islam, Jennifer Vance, Martin Poirier, et al.
Page
of 4