Detalhe da pesquisa
1.
Metrology Standards for Quantitative Imaging Biomarkers.
Radiology
; 277(3): 813-25, 2015 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-26267831
2.
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
3.
US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer.
J Clin Oncol
; 41(11): 2108-2116, 2023 04 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-36780610
4.
A Trans-Governmental Collaboration to Independently Evaluate SARS-CoV-2 Serology Assays.
Microbiol Spectr
; 10(1): e0156421, 2022 02 23.
Artigo
em Inglês
| MEDLINE | ID: mdl-35019677
5.
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
6.
Comparing two medical tests when results of reference standard are unavailable for those negative via both tests.
J Biopharm Stat
; 18(1): 145-66, 2008.
Artigo
em Inglês
| MEDLINE | ID: mdl-18161546
7.
The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions.
Stat Methods Med Res
; 24(1): 9-26, 2015 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-24919826
8.
Quantitative imaging biomarkers: a review of statistical methods for technical performance assessment.
Stat Methods Med Res
; 24(1): 27-67, 2015 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-24919831
9.
Considerations for Single-Measurement Risk-Stratification Strategies for Myocardial Infarction Using Cardiac Troponin Assays.
J Am Coll Cardiol
; 74(3): 283-284, 2019 07 23.
Artigo
em Inglês
| MEDLINE | ID: mdl-31319910
10.
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
11.
Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine.
Ther Deliv
; 1(5): 631-41, 2010 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-22833953
12.
Patient safety and the next generation of HPV DNA tests.
Am J Clin Pathol
; 135(5): 798-9; author reply 799-803, 2011 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-21502437
13.
Partly nonparametric approach for determining the limit of detection.
Clin Chem
; 50(4): 732-40, 2004 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-14764644