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Industry Perspective on Biomarker Development and Qualification

  • Published:2017-11-16 Issue:1 Volume:103 Page:27-31
  • ISSN:0009-9236
  • Container-title:Clinical Pharmacology & Therapeutics
  • language:en
  • Short-container-title:Clin. Pharmacol. Ther.

Author:

Gerlach Cory V.123,Derzi Mazin4,Ramaiah Shashi K.4,Vaidya Vishal S.1234

Affiliation:

1. Harvard Program in Therapeutic Science; Harvard Medical School; Boston Massachusetts USA

2. Renal Division; Brigham & Women's Hospital; Boston Massachusetts USA

3. Department of Environmental Health; Harvard T. H. Chan School of Public Health; Boston Massachusetts USA

4. Drug Safety Research and Development; Pfizer Inc.; Cambridge Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference10 articles.

1. FDA-NIH Biomarker Working Group 2016 BEST (Biomarkers, EndpointS, and other Tools) Resource

2. An analysis of the attrition of drug candidates from four major pharmaceutical companies;Waring;Nat. Rev. Drug Discov.,2015

3. Biomarker qualification: toward a multiple stakeholder framework for biomarker development, regulatory acceptance, and utilization;Amur;Clin. Pharmacol. Ther.,2015

4. Industry perspectives on biomarker qualification;Lavezzari;Clin. Pharmacol. Ther.,2016
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