Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020-Reference-Cited by-同舟云学术

Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020

Published:2022-03-05 Issue:1 Volume:112 Page:69-80
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Bakker Elisabeth¹,Hendrikse Natalie M.²,Ehmann Falk²,van der Meer Daniëlla S.¹³,Llinares Garcia Jordi²,Vetter Thorsten²,Starokozhko Viktoriia¹³,Mol Peter G.M.¹³⁴

Affiliation:

1. Department of Clinical Pharmacy and Pharmacology University of GroningenUniversity Medical Centre Groningen Groningen The Netherlands

2. European Medicines Agency Amsterdam The Netherlands

3. College ter Beoordeling van Geneesmiddelen–Medicines Evaluation Board Utrecht The Netherlands

4. Scientific Advice Working Party European Medicines Agency Amsterdam The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2554

Reference29 articles.

1. Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization

2. Integrating Personalized Medicine in the Health Care

3. The Value, Qualification, and Regulatory Use of Surrogate End Points in Drug Development

4. Biomarkers and personalized medicine: current status and further perspectives with special focus on dermatology

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