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Bioanalysis
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August 9, 2024
Re-thinking the current paradigm for clinical immunogenicity assessment: an update from the discussion in the European Bioanalysis Forum
Joanne Goodman, Kyra J Cowan, Michaela Golob, et al.
Bioanalysis
|
February 5, 2024
Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10 - keeping our finger on the pulse
Philip Timmerman, Matthew Barfield, Enric Bertran Portabella, et al.
Clinical Pharmacology and Therapeutics
|
January 20, 2023
Mitigating Drug-Target-Drug Complexes in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Switch C5 Inhibitors
Jun-Ichi Nishimura, Antoine Soubret, Noriko Arase, et al.
Blood
|
January 25, 2020
The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria
Alexander Röth, Jun-Ichi Nishimura, Zsolt Nagy, 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
|
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
|
August 16, 2023
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles <u>Part 2</u> - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization
Giane Sumner, Steve Keller, James Huleatt, et al.
Bioanalysis
|
January 29, 2021
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (<u>Part 2A</u> - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation <u>Part 2B</u> - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)
Susan Spitz, Yan Zhang, Sally Fischer, et al.
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of 4
Search research articles
Search
Showing results (31-40 of 38) with videos related to
Sort By:
Page
of 4
You have reached the last page of results.
This site can display upto 38 results.
Bioanalysis
|
August 9, 2024
Re-thinking the current paradigm for clinical immunogenicity assessment: an update from the discussion in the European Bioanalysis Forum
Joanne Goodman, Kyra J Cowan, Michaela Golob, et al.
Bioanalysis
|
February 5, 2024
Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10 - keeping our finger on the pulse
Philip Timmerman, Matthew Barfield, Enric Bertran Portabella, et al.
Clinical Pharmacology and Therapeutics
|
January 20, 2023
Mitigating Drug-Target-Drug Complexes in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Switch C5 Inhibitors
Jun-Ichi Nishimura, Antoine Soubret, Noriko Arase, et al.
Blood
|
January 25, 2020
The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria
Alexander Röth, Jun-Ichi Nishimura, Zsolt Nagy, 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
|
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
|
August 16, 2023
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles <u>Part 2</u> - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization
Giane Sumner, Steve Keller, James Huleatt, et al.
Bioanalysis
|
January 29, 2021
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (<u>Part 2A</u> - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation <u>Part 2B</u> - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)
Susan Spitz, Yan Zhang, Sally Fischer, et al.
Page
of 4