Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement-Reference-Cited by-同舟云学术

Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement

Published:2006-01-12 Issue:2 Volume:23 Page:312-328
ISSN:0724-8741
Container-title:Pharmaceutical Research
language:en
Short-container-title:Pharm Res

Author:

Lee Jean W.,Devanarayan Viswanath,Barrett Yu Chen,Weiner Russell,Allinson John,Fountain Scott,Keller Stephen,Weinryb Ira,Green Marie,Duan Larry,Rogers James A.,Millham Robert,O'Brien Peter J.,Sailstad Jeff,Khan Masood,Ray Chad,Wagner John A.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology

Link

http://link.springer.com/content/pdf/10.1007/s11095-005-9045-3.pdf

Reference30 articles.

1. Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development: A Conference Report

2. The price of innovation: new estimates of drug development costs

3. Trends in development and approval times for new therapeutics in the United States

4. FDA Mar 2004 report. Innovation or Stagnation? Challenge and opportunity on the critical path to new medical products. Available at http://www.fda.gov/oc/initiatives/criticalpath/.

5. The NIH Roadmap

Cited by 644 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Evaluating and Establishing the Linearity Interval and Extended Measuring Interval;Laboratory Medicine Online;2024-07-01

2. Associations of inflammatory and metabolic biomarkers with incident erosive hand osteoarthritis in the osteoarthritis initiative cohort;Osteoarthritis and Cartilage;2024-05

3. Plasma concentrations of thioredoxin, thioredoxin reductase and peroxiredoxin-4 can identify high risk patients and predict outcome in patients with acute coronary syndrome: A clinical observation;International Journal of Cardiology;2024-05

4. Validation and Suitability Assessment of Multiplex Mesoscale Discovery Immunogenicity Assay for Establishing Serological Signatures Using Vaccinated, Non-Vaccinated and Breakthrough SARS-CoV-2 Infected Cases;Vaccines;2024-04-18

5. A novel biomarker assay qualification strategy for rare human matrices – a case study of biomarkers in aqueous humor;Bioanalysis;2024-03-20