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Seema Kumar

Showing results (131-140 of 143) with videos related to

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The AAPS Journal|June 2, 2023
Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug DevelopmentJochem Gokemeijer, Yi Wen, Vibha Jawa, et al.
The AAPS Journal|July 1, 2026
Updated Recommendations for the Bioanalysis of Antibody-Drug Conjugates (ADC) from the ADC working group of the AAPS Bioanalytical CommunityJim X Shen, Robert Dodge, Shoshana Oberstein, et al.
The AAPS Journal|September 4, 2024
Correction to: Neutralizing Antibody Sample Testing and Report HarmonizationDarshana Jani, Michele Gunsior, Robin Marsden, et al.
The AAPS Journal|July 11, 2024
Neutralizing Antibody Sample Testing and Report HarmonizationDarshana Jani, Michele Gunsior, Robin Marsden, et al.
The Journal of Pediatrics|August 19, 2022
The Coronavirus Disease 2019 Pandemic is Associated with a Substantial Rise in Frequency and Severity of Presentation of Youth-Onset Type 2 DiabetesSheela N Magge, Risa M Wolf, Laura Pyle, et al.
The AAPS Journal|October 28, 2022
Anti-drug Antibody Sample Testing and Reporting HarmonizationDarshana Jani, Robin Marsden, Michele Gunsior, et al.
Bioanalysis|January 25, 2025
2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (<u>PART 2A</u> - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) <u>PART 2B</u> - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)Nicoletta Bivi, Danielle Graham, Laura Joglekar, et al.
Bioanalysis|August 1, 2023
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (<u>Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)Luying Pan, Johanna Mora, Karl Walravens, et al.
Bioanalysis|May 17, 2022
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (<u>Part 2</u> - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation)Sarah Hersey, Steve Keller, Joel Mathews, 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 15

Showing results (131-140 of 143) with videos related to

Sort By:
Pageof 15
The AAPS Journal|June 2, 2023
Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug DevelopmentJochem Gokemeijer, Yi Wen, Vibha Jawa, et al.
The AAPS Journal|July 1, 2026
Updated Recommendations for the Bioanalysis of Antibody-Drug Conjugates (ADC) from the ADC working group of the AAPS Bioanalytical CommunityJim X Shen, Robert Dodge, Shoshana Oberstein, et al.
The AAPS Journal|September 4, 2024
Correction to: Neutralizing Antibody Sample Testing and Report HarmonizationDarshana Jani, Michele Gunsior, Robin Marsden, et al.
The AAPS Journal|July 11, 2024
Neutralizing Antibody Sample Testing and Report HarmonizationDarshana Jani, Michele Gunsior, Robin Marsden, et al.
The Journal of Pediatrics|August 19, 2022
The Coronavirus Disease 2019 Pandemic is Associated with a Substantial Rise in Frequency and Severity of Presentation of Youth-Onset Type 2 DiabetesSheela N Magge, Risa M Wolf, Laura Pyle, et al.
The AAPS Journal|October 28, 2022
Anti-drug Antibody Sample Testing and Reporting HarmonizationDarshana Jani, Robin Marsden, Michele Gunsior, et al.
Bioanalysis|January 25, 2025
2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (<u>PART 2A</u> - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) <u>PART 2B</u> - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)Nicoletta Bivi, Danielle Graham, Laura Joglekar, et al.
Bioanalysis|August 1, 2023
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (<u>Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)Luying Pan, Johanna Mora, Karl Walravens, et al.
Bioanalysis|May 17, 2022
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (<u>Part 2</u> - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation)Sarah Hersey, Steve Keller, Joel Mathews, 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 15