Concepedia

Biomarker Qualification

Biomarker Qualification is the formal process by which a biomarker is scientifically validated and accepted by regulatory authorities for a specific context of use in drug development or clinical decision-making, distinguishing it from mere biomarker discovery or analytical validation through its regulatory and evidentiary rigor.

64

Publications

4K

Citations

608

Authors

275

Institutions

Publications per year

2017–2026

22

Parents

Publications

64

Kidney injury molecule-1 outperforms traditional biomarkers of kidney injury in preclinical biomarker qualification studies

Vishal S. Vaidya, Josef Ozer, Frank Dieterle et al. · Nature Biotechnology · 2010 · 650 citations

, , +11

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

Frank Dieterle, Frank D. Sistare, Federico Goodsaid et al. · Nature Biotechnology · 2010 · 406 citations

, , +13

Biomarkers and Surrogate End Points for Fit-for-Purpose Development and Regulatory Evaluation of New Drugs

JA Wagner, Subbu Williams, Chris Webster · Clinical Pharmacology & Therapeutics · 2006 · 201 citations

, , +14

Implementation of proteomic biomarkers: making it work

Harald Mischak, John P. A. Ioannidis, Àngel Argilés et al. · European Journal of Clinical Investigation · 2012 · 169 citations · Full text

, , +17

Biomarker qualification pilot process at the US Food and Drug Administration

Federico Goodsaid, Felix W. Frueh · The AAPS Journal · 2007 · 154 citations · Full text

, , +15

1–5 of 64

Authors

608

  1. FG
    Federico Goodsaid

    Center for Drug Evaluation and Research, United States

    5 publications · 698 citations

    5

    h-index

  2. FD
    Frank D. Sistare

    United States Military Academy, United States

    3 publications · 1.1K citations

    3

    h-index

  3. SP
    Sean P. Troth

    United States Military Academy, United States

    3 publications · 1.1K citations

    3

    h-index

  4. AT
    Aliza Thompson

    Center for Drug Evaluation and Research, United States

    3 publications · 468 citations

    3

    h-index

  5. EG
    Elizabeth G. Walker

    Critical Path Institute, United States

    3 publications · 437 citations

    3

    h-index

1–5 of 608

Institutions

275

  1. United States Food and Drug Administration

    Silver Spring, United States

    10 h-index

    35 publications

    6.8K citations

  2. Center for Drug Evaluation and Research

    Silver Spring, United States

    9 h-index

    29 publications

    1.4K citations

  3. Pfizer (United States)

    New York, United States

    8 h-index

    16 publications

    2.6K citations

  4. Critical Path Institute

    Tucson, United States

    6 h-index

    25 publications

    1.7K citations

  5. GlaxoSmithKline (United States)

    Philadelphia, United States

    4 h-index

    4 publications

    521 citations

  6. Harvard University

    Cambridge, United States

    4 h-index

    11 publications

    3.2K citations

  7. Stanford University

    Stanford, United States

    4 h-index

    9 publications

    645 citations

  8. AstraZeneca (United Kingdom)

    Cambridge, United Kingdom

    4 h-index

    22 publications

    1.4K citations

1–8 of 275

Venues

  1. Clinical Pharmacology & Therapeutics

    CPT · 6 publications · 386 citations

    6

    h-index

  2. PubMed

    Repository · 3 publications · 90 citations

    3

    h-index

  3. Nature Biotechnology

    3 publications · 1.1K citations

    3

    h-index

  4. Frontiers in Medicine

    2 publications · 38 citations

    2

    h-index

  5. Toxicologic Pathology

    2 publications · 76 citations

    2

    h-index

1–5