Detalhe da pesquisa
1.
Statistical design for biospecimen cohort size in proteomics-based biomarker discovery and verification studies.
J Proteome Res
; 12(12): 5383-94, 2013 Dec 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-24063748
2.
FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors.
Clin Cancer Res
; 29(18): 3573-3578, 2023 09 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-37265412
3.
Characterization of whole genome amplified (WGA) DNA for use in genotyping assay development.
BMC Genomics
; 13: 217, 2012 Jun 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-22655855
4.
The journey to regulation of protein-based multiplex quantitative assays.
Clin Chem
; 57(4): 560-7, 2011 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-21300740
5.
A community effort to identify and correct mislabeled samples in proteogenomic studies.
Patterns (N Y)
; 2(5): 100245, 2021 May 14.
Artigo
em Inglês
| MEDLINE | ID: mdl-34036290
6.
Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics.
Clin Chem
; 56(2): 237-43, 2010 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-20007859
7.
Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration.
Clin Chem
; 56(2): 165-71, 2010 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-20007858
8.
Best practices for benchmarking germline small-variant calls in human genomes.
Nat Biotechnol
; 37(5): 555-560, 2019 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-30858580
9.
Author Correction: Best practices for benchmarking germline small-variant calls in human genomes.
Nat Biotechnol
; 37(5): 567, 2019 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-30899106
10.
FDA perspectives on potential microarray-based clinical diagnostics.
Hum Genomics
; 2(4): 236-43, 2006 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-16460648
11.
Biomarkers for pharmacogenetic and pharmacogenomic studies: Locking down analytical performance.
Drug Discov Today Technol
; 4(1): 17-20, 2007.
Artigo
em Inglês
| MEDLINE | ID: mdl-24980716
12.
Biomarkers for pharmacogenetic and pharmacogenomic studies: special issues in analytical performance.
Drug Discov Today Technol
; 4(1): 21-4, 2007.
Artigo
em Inglês
| MEDLINE | ID: mdl-24980717
13.
Principles and Recommendations for Standardizing the Use of the Next-Generation Sequencing Variant File in Clinical Settings.
J Mol Diagn
; 19(3): 417-426, 2017 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-28315672
14.
Direct-to-consumer genetic testing: reliable or risky?
Clin Chem
; 57(12): 1641-4, 2011 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-21885623
15.
A research roadmap for next-generation sequencing informatics.
Sci Transl Med
; 8(335): 335ps10, 2016 04 20.
Artigo
em Inglês
| MEDLINE | ID: mdl-27099173
16.
The first FDA marketing authorizations of next-generation sequencing technology and tests: challenges, solutions and impact for future assays.
Expert Rev Mol Diagn
; 15(1): 33-40, 2015 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-25370936
17.
Clinical and molecular study in congenital muscular dystrophy with partial laminin alpha 2 (LAMA2) deficiency.
Hum Mutat
; 21(2): 103-11, 2003 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-12552556
18.
Right data for right patient-a precisionFDA NCI-CPTAC Multi-omics Mislabeling Challenge.
Nat Med
; 24(9): 1301-1302, 2018 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-30194412
19.
Regulatory perspective on translating proteomic biomarkers to clinical diagnostics.
J Proteomics
; 74(12): 2682-90, 2011 Nov 18.
Artigo
em Inglês
| MEDLINE | ID: mdl-21856459
20.
US FDA and personalized medicine: in vitro diagnostic regulatory perspective.
Per Med
; 7(5): 517-530, 2010 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-29776248