Concepedia

Extrapolation Of Efficacy

Extrapolation of Efficacy is a methodological approach in pediatric clinical trials that involves inferring the effectiveness of a medical intervention in a pediatric population based on robust evidence of efficacy in adults, supplemented by pharmacokinetic, pharmacodynamic, and disease progression similarities between the two populations.

24

Publications

1.2K

Citations

121

Authors

73

Institutions

Publications per year

2017–2026

16

Parents

Publications

24

Extrapolation of Adult Data and Other Data in Pediatric Drug-Development Programs

Julia Dunne, William J. Rodríguez, Michael D. Murphy et al. · PEDIATRICS · 2011 · 311 citations

, , +16

Extrapolation of Adult Data and Other Data in Pediatric Drug-Development Programs

PEDIATRICS · 2011 · 226 citations

, , +16

Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation

Margaret Gamalo, Jasmina Savić, Cynthia Basu et al. · Pharmaceutical Statistics · 2017 · 92 citations

, , +17

Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars?

Howard Lee · The AAPS Journal · 2013 · 88 citations · Full text

, , +11

Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned

Haihao Sun, Jean Temeck, Wiley Chambers et al. · Therapeutic Innovation & Regulatory Science · 2017 · 72 citations · Full text

, , +14

1–5 of 24

Authors

121

  1. MG
    Margaret Gamalo

    Eli Lilly (United States), United States

    4 publications · 137 citations

    4

    h-index

  2. LY
    Lynne Yao

    Center for Drug Evaluation and Research, United States

    3 publications · 340 citations

    3

    h-index

  3. CO
    Cécile Ollivier

    European Medicines Agency, Netherlands

    2 publications · 55 citations

    2

    h-index

  4. CB
    Christina Bucci‐Rechtweg

    Novartis (United States), United States

    2 publications · 31 citations

    2

    h-index

  5. GJ
    Gilbert J. Burckart

    University of Pittsburgh, United States

    2 publications · 325 citations

    2

    h-index

1–5 of 121

Institutions

73

  1. Center for Drug Evaluation and Research

    Silver Spring, United States

    7 h-index

    19 publications

    716 citations

  2. Novartis (Switzerland)

    Basel, Switzerland

    5 h-index

    9 publications

    139 citations

  3. United States Food and Drug Administration

    Silver Spring, United States

    4 h-index

    19 publications

    579 citations

  4. Eli Lilly (United States)

    Indianapolis, United States

    3 h-index

    5 publications

    302 citations

  5. Johnson & Johnson (United States)

    New Brunswick, United States

    3 h-index

    3 publications

    125 citations

  6. European Medicines Agency

    Amsterdam, Netherlands

    3 h-index

    7 publications

    242 citations

  7. Novartis (United States)

    New York, United States

    2 h-index

    4 publications

    66 citations

  8. Amgen (United States)

    Thousand Oaks, United States

    2 h-index

    2 publications

    111 citations

1–8 of 73

Venues

  1. Therapeutic Innovation & Regulatory Science

    TIRS · 4 publications · 122 citations

    4

    h-index

  2. PEDIATRICS

    2 publications · 537 citations

    2

    h-index

  3. Journal of Biopharmaceutical Statistics

    JBS · 1 publications · 15 citations

    1

    h-index

  4. 1

    h-index

  5. The Journal of Clinical Pharmacology

    1 publications · 14 citations

    1

    h-index

1–5