Detalles de la búsqueda
1.
Analytical techniques for multiplex analysis of protein biomarkers.
Expert Rev Proteomics
; 17(4): 257-273, 2020 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-32427033
2.
Considerations for Soluble Protein Biomarker Blood Sample Matrix Selection.
AAPS J
; 22(2): 38, 2020 01 29.
Artículo
en Inglés
| MEDLINE | ID: mdl-31997095
3.
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).
Bioanalysis
; 11(24): 2207-2244, 2019 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-31820675
4.
Clinical biomarker validation.
Bioanalysis
; 10(12): 957-968, 2018 Jun 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29923754
5.
Considerations for drug development biomarker assays in the clinical laboratory.
Bioanalysis
; 15(10): 533-536, 2023 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-37293797
6.
Feedback from the EBF - Focus Workshop: bringing assay validation and analysis of biomarkers into practice.
Bioanalysis
; 9(9): 675-681, 2017 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-28520459
7.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-28339299
8.
Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.
AAPS J
; 18(1): 1-14, 2016 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-26377333
9.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-27855512
10.
Ask the experts: method transfer.
Bioanalysis
; 7(7): 789-93, 2015.
Artículo
en Inglés
| MEDLINE | ID: mdl-25932512
11.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-26635247
12.
Recommendations on incurred sample stability (ISS) by GCC.
Bioanalysis
; 6(18): 2385-90, 2014 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-25384591
13.
Ask the experts: automation: part I.
Bioanalysis
; 5(16): 1953-62, 2013 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-23937129
14.
Recommendations on biomarker bioanalytical method validation by GCC.
Bioanalysis
; 4(20): 2439-46, 2012 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-23157353
15.
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).
Bioanalysis
; 4(17): 2117-26, 2012 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-23013394
16.
Automated immunoassay equipment platforms for analytical support of pharmaceutical and biopharmaceutical development.
Bioanalysis
; 3(24): 2803-16, 2011 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-22185280
17.
7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing.
Bioanalysis
; 6(20): 2713-20, 2014 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-25413703
18.
Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars.
Bioanalysis
; 4(19): 2335-42, 2012 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-23088460
19.
Fit-for-purpose method development and validation for successful biomarker measurement.
Pharm Res
; 23(2): 312-28, 2006 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-16397743
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