Concepedia

Post-approval Changes

Post-Approval Changes is a regulatory science construct that refers to modifications made to a product’s composition, manufacturing process, labeling, or intended use after it has received formal authorization from a competent authority, necessitating notification, prior approval, or documentation in accordance with established pharmacovigilance and quality assurance frameworks.

20

Publications

482

Citations

99

Authors

46

Institutions

Publications per year

2017–2026

10

Parents

Publications

20

Mitigating Deficiencies in Evidence during Regulatory Assessments of Advanced Therapies: A Comparative Study with Other Biologicals

Magdi Elsallab, Christopher A. Bravery, Mohamed Abou‐El‐Enein · Molecular Therapy — Methods & Clinical Development · 2020 · 54 citations · Full text

, , +17

FDA approves controversial Alzheimer’s drug despite uncertainty over effectiveness

Elisabeth Mahase · BMJ · 2021 · 49 citations

, , +17

Assessment of Similarity Factor Using Different Weighting Approaches

Mukesh Gohel, Krishnakant G. Sarvaiya, Neelima R. Mehta et al. · Dissolution Technologies · 2005 · 41 citations · Full text

, , +17

In Vitro?In Vivo Correlation (IVIVC): A Strategic Tool in Drug Development

Ana Fortuna · Journal of Bioequivalence & Bioavailability · 2011 · 40 citations · Full text

, , +17

A new approach to modelling the relationship betweenin vitro andin vivo drug dissolution/absorption

Adrian Dunne, Tom O’Hara, John Devane · Statistics in Medicine · 1999 · 33 citations

, , +17

1–5 of 20

Authors

99

  1. TG
    Thierry Gastineau

    Sanofi (France), France

    2 publications · 22 citations

    2

    h-index

  2. VP
    Vinod P. Shah

    Center for Drug Evaluation and Research, United States

    2 publications · 56 citations

    2

    h-index

  3. NR
    Neelima R. Mehta

    University of California, Davis, United States

    1 publications · 41 citations

    1

    h-index

  4. SA
    Stan Altan

    Janssen (United States), United States

    1 publications · 14 citations

    1

    h-index

  5. ND
    Norbert De Clercq

    GlaxoSmithKline (Belgium), Belgium

    1 publications · 10 citations

    1

    h-index

1–5 of 99

Institutions

46

  1. GlaxoSmithKline (Belgium)

    Wavre, Belgium

    3 h-index

    4 publications

    47 citations

  2. Sanofi (France)

    Paris, France

    2 h-index

    3 publications

    34 citations

  3. Johnson & Johnson (United States)

    New Brunswick, United States

    1 h-index

    2 publications

    26 citations

  4. Janssen (Belgium)

    Beerse, Belgium

    1 h-index

    2 publications

    28 citations

  5. Massachusetts General Hospital

    Boston, United States

    1 h-index

    9 publications

    99 citations

  6. European Medicines Agency

    Amsterdam, Netherlands

    1 h-index

    3 publications

    81 citations

  7. University College Dublin

    Dublin, Ireland

    1 h-index

    1 publications

    33 citations

  8. Berlin Institute of Health at Charité - Universitätsmedizin Berlin

    Berlin, Germany

    1 h-index

    2 publications

    108 citations

1–8 of 46

Venues

  1. Regenerative Medicine

    2 publications · 39 citations

    2

    h-index

  2. Pharmaceutical Development and Technology

    2 publications · 56 citations

    2

    h-index

  3. 1

    h-index

  4. Pharmaceutics

    1 publications · 14 citations

    1

    h-index

  5. 1

    h-index

1–5