Detalhe da pesquisa
1.
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Bioanalysis
; 16(7): 77-119, 2024 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-38389403
2.
PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
AAPS J
; 25(5): 78, 2023 07 31.
Artigo
em Inglês
| MEDLINE | ID: mdl-37523051
3.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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
4.
Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.
Mol Ther Methods Clin Dev
; 26: 471-494, 2022 Sep 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-36092368
5.
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
6.
A competitive ligand-binding assay to detect neutralizing antibodies to a bispecific drug using a multiplex Meso Scale Discovery platform.
Bioanalysis
; 13(22): 1659-1669, 2021 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-34743610
7.
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
8.
Strategies to develop highly drug-tolerant cell-based neutralizing antibody assay: neutralizing antidrug antibodies extraction and drug depletion.
Bioanalysis
; 12(18): 1279-1293, 2020 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-32945693
9.
Criteria to Reevaluate Anti-drug Antibody Assay Cut Point Suitability in the Target Population.
AAPS J
; 22(2): 19, 2020 01 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-31900604
10.
Anti-drug Antibody Assay Conditions Significantly Impact Assay Screen and Confirmatory Cut-Points.
AAPS J
; 21(4): 71, 2019 06 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-31161482
11.
Anti-drug Antibody Assay Validation: Improved Reporting of the Assay Selectivity via Simpler Positive Control Recovery Data Analysis.
AAPS J
; 21(5): 76, 2019 06 18.
Artigo
em Inglês
| MEDLINE | ID: mdl-31214862
12.
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Bioanalysis
; 11(23): 2099-2132, 2019 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-31833782
13.
A Simple Approach to Determine a Curve Fitting Model with a Correct Weighting Function for Calibration Curves in Quantitative Ligand Binding Assays.
AAPS J
; 20(3): 45, 2018 03 13.
Artigo
em Inglês
| MEDLINE | ID: mdl-29536273
14.
Approaches to Resolve False Reporting in Neutralizing Antibody Assays Caused by Reagent Leaching from Affinity Capture Elution Solid Phase.
AAPS J
; 21(1): 4, 2018 11 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-30402825
15.
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).
Bioanalysis
; 10(24): 1973-2001, 2018 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-30488726
16.
Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves.
AAPS J
; 20(1): 22, 2017 12 27.
Artigo
em Inglês
| MEDLINE | ID: mdl-29282611
17.
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Bioanalysis
; 9(24): 1967-1996, 2017 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-29205064
18.
The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.
Bioanalysis
; 9(7): 505-516, 2017 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-28339299
19.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Bioanalysis
; 8(23): 2475-2496, 2016 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-27855512
20.
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).
Bioanalysis
; 7(24): 3107-24, 2015 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-26635247