Showing results (11-20 of 22) with videos related to

Sort By:
Pageof 3
The American Journal of Pathology|January 30, 2010
Pathways contributing to development of spontaneous mammary tumors in BALB/c-Trp53+/- miceHaoheng Yan, Anneke C Blackburn, S Christine McLary, et al.
The AAPS Journal|December 2, 2021
Anti-drug Antibody Validation Testing and Reporting HarmonizationHeather Myler, João Pedras-Vasconcelos, Kelli Phillips, et al.
The AAPS Journal|July 8, 2023
Neutralizing Antibody Validation Testing and Reporting HarmonizationHeather Myler, João Pedras-Vasconcelos, Todd Lester, et al.
The AAPS Journal|October 28, 2022
Anti-drug Antibody Sample Testing and Reporting HarmonizationDarshana Jani, Robin Marsden, Michele Gunsior, et al.
Bioanalysis|November 30, 2018
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity)Hendrik Neubert, Timothy Olah, Anita Lee, et al.
Bioanalysis|February 3, 2021
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (<u>Part 3</u> - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)Bart Corsaro, Tong-Yuan Yang, Rocio Murphy, 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|May 17, 2022
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (<u>Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)Lina Loo, Shannon Harris, Mark Milton, et al.
Bioanalysis|December 11, 2019
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)Steven Piccoli, Devangi Mehta, Alessandra Vitaliti, 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 3