Concepedia

Post-authorization Commitments

Post-Authorization Commitments is a regulatory requirement in the pharmaceutical domain that consists of specific studies or activities mandated or agreed upon by the marketing authorization holder after approval to further evaluate the safety, efficacy, or quality of a medicinal product under real-world use conditions.

7

Publications

178

Citations

48

Authors

27

Institutions

Publications per year

2017–2026

5

Parents

Publications

7

Characteristics and follow‐up of postmarketing studies of conditionally authorized medicines in the EU

Jarno Hoekman, Thea T. Klamer, Aukje K. Mantel‐Teeuwisse et al. · British Journal of Clinical Pharmacology · 2016 · 54 citations · Full text

, , +17

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

Joshua D. Wallach, Anita T. Luxkaranayagam, Sanket S. Dhruva et al. · BMC Medicine · 2019 · 26 citations · Full text

, , +15

Development and Use of Gene Therapy Orphan Drugs—Ethical Needs for a Broader Cooperation Between the Pharmaceutical Industry and Society

Sándor Kerpel‐Fronius, Varvara Baroutsou, Sander Becker et al. · Frontiers in Medicine · 2020 · 25 citations · Full text

, , +17

The role of Real-World Data and evidence in oncology medicines approved in EU in 2018–2019

Sini Marika Eskola, Hubertus G.M. Leufkens, Andrew Bate et al. · Journal of Cancer Policy · 2023 · 20 citations · Full text

, , +17

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

Canary Wharf, Ellen London · 2015 · 19 citations

, , +15

1–5 of 7

Authors

48

  1. ML
    Marie L. De Bruin

    Utrecht University, Netherlands

    2 publications · 74 citations

    2

    h-index

  2. EA
    Einar Andreassen

    Trinity College Dublin, Ireland

    1 publications · 16 citations

    1

    h-index

  3. KM
    Kotone Matsuyama

    Nippon Medical School, Japan

    1 publications · 25 citations

    1

    h-index

  4. JD
    Joshua D. Wallach

    Yale University, United States

    1 publications · 26 citations

    1

    h-index

  5. SC
    Suzannah Chapman

    Zorginstituut Nederland, Netherlands

    1 publications · 16 citations

    1

    h-index

1–5 of 48

Institutions

27

  1. Pharmo Institute

    Utrecht, Netherlands

    3 h-index

    8 publications

    322 citations

  2. Utrecht University

    Utrecht, The Netherlands

    3 h-index

    11 publications

    382 citations

  3. London School of Hygiene & Tropical Medicine

    London, United Kingdom

    2 h-index

    2 publications

    36 citations

  4. Nippon Medical School

    Tokyo, Japan

    1 h-index

    1 publications

    25 citations

  5. University Medical Center Utrecht

    Utrecht, The Netherlands

    1 h-index

    1 publications

    20 citations

  6. National Centre for Pharmacoeconomics

    Dublin, Ireland

    1 h-index

    1 publications

    16 citations

  7. University of Iceland

    Reykjavik, Iceland

    1 h-index

    1 publications

    20 citations

  8. Zorginstituut Nederland

    Diemen, The Netherlands

    1 h-index

    3 publications

    48 citations

1–8 of 27

Venues

  1. British Journal of Clinical Pharmacology

    BJCP · 1 publications · 54 citations

    1

    h-index

  2. Regenerative Medicine

    1 publications · 18 citations

    1

    h-index

  3. Frontiers in Medicine

    1 publications · 25 citations

    1

    h-index

  4. BMC Medicine

    1 publications · 26 citations

    1

    h-index

  5. Journal of Cancer Policy

    JCPO · 1 publications · 20 citations

    1

    h-index

1–5