Concepedia

Regulatory Submissions

Regulatory Submissions is a formal process by which clinical trial and regulatory documentation are systematically compiled, reviewed, and presented to health authorities to seek approval, clearance, or oversight for investigational or marketed pharmaceuticals, biologics, or medical devices.

160

Publications

9.4K

Citations

1K

Authors

431

Institutions

Publications per year

2017–2026

76

Parents

Publications

160

COVID-19 Antibody Seroprevalence in Santa Clara County, California

Eran Bendavid, Bianca Mulaney, Neeraj Sood et al. · medRxiv · 2020 · 561 citations · Full text

, , +9

COVID-19 antibody seroprevalence in Santa Clara County, California

Eran Bendavid, Bianca Mulaney, Neeraj Sood et al. · International Journal of Epidemiology · 2021 · 431 citations · Full text

, , +9

Compliance with Results Reporting at ClinicalTrials.gov

Monique Anderson, Karen Chiswell, Eric D. Peterson et al. · New England Journal of Medicine · 2015 · 382 citations · Full text

, , +15

Biospecimen Reporting for Improved Study Quality (BRISQ)

Helen M. Moore, Andréa B. Kelly, Scott D. Jewell et al. · Journal of Proteome Research · 2011 · 331 citations · Full text

, , +6

In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products

Marco Viceconti, Francesco Pappalardo, Blanca Rodríguez et al. · Methods · 2020 · 327 citations · Full text

, , +14

1–5 of 160

Authors

1K

  1. SN
    Sibylle Neuhoff

    Simcyp (United Kingdom), United Kingdom

    3 publications · 168 citations

    3

    h-index

  2. HP
    Helen Prior

    National Centre for the Replacement Refinement and Reduction of Animals in Research, United Kingdom

    3 publications · 82 citations

    3

    h-index

  3. LK
    Lisette Krul

    Netherlands Organisation for Applied Scientific Research, Netherlands

    2 publications · 39 citations

    2

    h-index

  4. SH
    Shiew‐Mei Huang

    Center for Drug Evaluation and Research, United States

    2 publications · 198 citations

    2

    h-index

  5. CS
    Claire S. Zhu

    National Cancer Institute, United States

    2 publications · 522 citations

    2

    h-index

1–5 of 1K

Institutions

431

  1. United States Food and Drug Administration

    Silver Spring, United States

    21 h-index

    98 publications

    6.7K citations

  2. Center for Drug Evaluation and Research

    Silver Spring, United States

    16 h-index

    89 publications

    5.6K citations

  3. Pfizer (United States)

    New York, United States

    10 h-index

    26 publications

    1K citations

  4. Merck & Co., Inc., Rahway, NJ, USA (United States)

    Rahway, United States

    8 h-index

    13 publications

    456 citations

  5. Duke University

    Durham, United States

    8 h-index

    16 publications

    1.9K citations

  6. National Institutes of Health

    Bethesda, United States

    8 h-index

    16 publications

    1.1K citations

  7. Eli Lilly (United States)

    Indianapolis, United States

    8 h-index

    8 publications

    440 citations

  8. Roche (Switzerland)

    Basel, Switzerland

    6 h-index

    10 publications

    610 citations

1–8 of 431

Venues

  1. Clinical Pharmacology & Therapeutics

    CPT · 6 publications · 529 citations

    6

    h-index

  2. PubMed

    Repository · 6 publications · 225 citations

    6

    h-index

  3. CPT Pharmacometrics & Systems Pharmacology

    PSP · 5 publications · 217 citations

    5

    h-index

  4. Drug Metabolism and Disposition

    4 publications · 205 citations

    4

    h-index

  5. Toxicological Sciences

    4 publications · 276 citations

    4

    h-index

1–5