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1.
2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (PART 2 - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).
Bioanalysis
; 16(8): 179-220, 2024.
Artículo
en Inglés
| MEDLINE | ID: mdl-38899739
2.
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 Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Bioanalysis
; 15(15): 861-903, 2023 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-37584363
3.
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).
Bioanalysis
; 14(10): 627-692, 2022 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578974
4.
The Evolution of Single-Cell Analysis and Utility in Drug Development.
AAPS J
; 23(5): 98, 2021 08 13.
Artículo
en Inglés
| MEDLINE | ID: mdl-34389904
5.
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 13(5): 295-361, 2021 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-33511867
6.
Tp63-expressing adult epithelial stem cells cross lineages boundaries revealing latent hairy skin competence.
Nat Commun
; 11(1): 5645, 2020 11 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-33159086
7.
Progress towards global standardization for quantitative flow cytometry.
Bioanalysis
; 13(21): 1591-1595, 2021 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-34528829
8.
Inductive interactions mediated by interplay of asymmetric signalling underlie development of adult haematopoietic stem cells.
Nat Commun
; 7: 10784, 2016 Mar 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-26952187
9.
Extensive hematopoietic stem cell generation in the AGM region via maturation of VE-cadherin+CD45+ pre-definitive HSCs.
Cell Stem Cell
; 3(1): 99-108, 2008 Jul 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-18593562
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