Concepedia

Post-authorization Safety Study Design

Post-Authorization Safety Study Design is a systematic methodological framework that specifies the scientific and operational structure for evaluating the safety of a medicinal product after regulatory approval, distinguishing it from pre-authorization or exploratory research designs by its focus on real-world evidence, regulatory compliance, and risk assessment within post-marketing surveillance contexts.

40

Publications

945

Citations

337

Authors

268

Institutions

Publications per year

2017–2026

23

Parents

Publications

40

The Fate of FDA Postapproval Studies

Steven Woloshin, Lisa M. Schwartz, Brian S. White et al. · New England Journal of Medicine · 2017 · 69 citations

, , +17

Evaluation of Post-Authorization Safety Studies in the First Cohort of EU Risk Management Plans at Time of Regulatory Approval

Thijs J. Giezen, Aukje K. Mantel‐Teeuwisse, Sabine M. J. M. Straus et al. · Drug Safety · 2009 · 58 citations

, , +17

The PANGAEA study design – a prospective, multicenter, non-interventional, long-term study on fingolimod for the treatment of multiple sclerosis in daily practice

Tjalf Ziemssen, Raimar Kern, Christian Cornelissen · BMC Neurology · 2015 · 54 citations · Full text

, , +15

Lessons learned on the design and the conduct of Post‐Authorization Safety Studies: review of 3 years of PRAC oversight

Pierre Engel, Mariana Ferreira Almas, Marie L. De Bruin et al. · British Journal of Clinical Pharmacology · 2016 · 51 citations · Full text

, , +16

Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe

Manjit Matharu, Julio Pascual, Ingela Nilsson Remahl et al. · Cephalalgia · 2017 · 48 citations · Full text

, , +16

1–5 of 40

Authors

337

  1. TZ
    Tjalf Ziemssen

    University Hospital Carl Gustav Carus, Germany

    4 publications · 128 citations

    4

    h-index

  2. MF
    Martha Feucht

    Medical University of Vienna, Austria

    2 publications · 41 citations

    2

    h-index

  3. JH
    Judith Haas

    University of Rostock, Germany

    2 publications · 57 citations

    2

    h-index

  4. VC
    Vincent Cottin

    Hôpital Louis Pradel, France

    2 publications · 36 citations

    2

    h-index

  5. CC
    Christian Cornelissen

    Novartis (Germany), Germany

    2 publications · 89 citations

    2

    h-index

1–5 of 337

Institutions

268

  1. Karolinska Institutet

    Stockholm, Sweden

    4 h-index

    4 publications

    133 citations

  2. Karolinska University Hospital

    Stockholm, Sweden

    3 h-index

    3 publications

    81 citations

  3. Novartis (Germany)

    Nuremberg, Germany

    3 h-index

    15 publications

    505 citations

  4. University Hospital Carl Gustav Carus

    Dresden, Germany

    3 h-index

    4 publications

    147 citations

  5. University College London

    London, United Kingdom

    3 h-index

    3 publications

    95 citations

  6. Hôpital Necker-Enfants Malades

    Paris, France

    3 h-index

    3 publications

    68 citations

  7. Vall d'Hebron Hospital Universitari

    Barcelona, Spain

    2 h-index

    2 publications

    41 citations

  8. Stanford University

    Stanford, United States

    2 h-index

    2 publications

    55 citations

1–8 of 268

Venues

  1. New England Journal of Medicine

    NEJM · 2 publications · 106 citations

    2

    h-index

  2. Frontiers in Neurology

    2 publications · 38 citations

    2

    h-index

  3. Drug Safety

    2 publications · 88 citations

    2

    h-index

  4. Journal of Clinical Oncology

    2 publications · 45 citations

    2

    h-index

  5. Advances in Therapy

    1 publications · 20 citations

    1

    h-index

1–5