Detalhe da pesquisa
1.
Application of blood microsampling in cynomolgus monkey and demonstration of equivalent monoclonal antibody PK parameters compared to conventional sampling.
Pharm Res
; 38(5): 819-830, 2021 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-33982224
2.
Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling.
Pharm Res
; 36(12): 169, 2019 Oct 25.
Artigo
em Inglês
| MEDLINE | ID: mdl-31654236
3.
Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.
Mol Ther Methods Clin Dev
; 32(1): 101217, 2024 Mar 14.
Artigo
em Inglês
| MEDLINE | ID: mdl-38496304
4.
Proposed mechanism of off-target toxicity for antibody-drug conjugates driven by mannose receptor uptake.
Cancer Immunol Immunother
; 62(2): 217-23, 2013 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-23223907
5.
Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology.
Regul Toxicol Pharmacol
; 67(3): 382-91, 2013 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-24012707
6.
Evolution of Antidrug Antibody Assays During the Development of Anti-Tissue Factor Pathway Inhibitor Monoclonal Antibody Marstacimab.
AAPS J
; 25(5): 84, 2023 08 23.
Artigo
em Inglês
| MEDLINE | ID: mdl-37610502
7.
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy.
AAPS J
; 25(3): 47, 2023 04 26.
Artigo
em Inglês
| MEDLINE | ID: mdl-37101079
8.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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 (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Bioanalysis
; 15(14): 773-814, 2023 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-37526071
9.
Determination of Anti-drug Antibody Affinity in Clinical Study Samples Provides a Tool for Evaluation of Immune Response Maturation.
AAPS J
; 24(6): 114, 2022 11 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-36324032
10.
When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform.
AAPS J
; 24(3): 68, 2022 05 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-35554731
11.
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 (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Bioanalysis
; 14(11): 737-793, 2022 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-35578991
12.
Feasibility of singlicate-based analysis in bridging ADA assay on Meso-Scale Discovery platform: comparison with duplicate analysis.
Bioanalysis
; 13(14): 1123-1134, 2021 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-34275328
13.
Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays.
AAPS J
; 23(6): 108, 2021 09 16.
Artigo
em Inglês
| MEDLINE | ID: mdl-34529177
14.
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 (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Bioanalysis
; 13(6): 415-463, 2021 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-33533276
15.
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos).
Bioanalysis
; 13(4): 203-238, 2021 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-33470871
16.
Current Considerations for Immunoglobulin Isotype Characterization of Antibody Response against Biotherapeutics.
AAPS J
; 22(6): 144, 2020 11 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-33161459
17.
Current Considerations on Characterization of Immune Response to Multi-Domain Biotherapeutics.
BioDrugs
; 34(1): 39-54, 2020 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-31641991
18.
Development of a Highly Specific Anti-drug Antibody Assay in Support of a Nanoparticle-based Therapeutic.
AAPS J
; 22(4): 81, 2020 06 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-32488626
19.
Correction to: Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays.
AAPS J
; 22(2): 42, 2020 Feb 04.
Artigo
em Inglês
| MEDLINE | ID: mdl-32020345
20.
Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays.
AAPS J
; 22(2): 24, 2020 01 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-31907680