Concepedia

Equivalence Margin Estimation

Equivalence Margin Estimation is the statistical methodology used to define the acceptable bounds within which the pharmacokinetic parameters of a test and reference formulation must lie to be considered therapeutically interchangeable in a single-dose bioequivalence study.

23

Publications

1.1K

Citations

136

Authors

91

Institutions

Publications per year

2017–2026

15

Parents

Publications

23

Quality of Reporting of Noninferiority and Equivalence Randomized Trials

Anne Le Hénanff, Bruno Giraudeau, Gabriel Baron et al. · JAMA · 2006 · 269 citations

, , +16

Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study

Kim Papp, H. Bachelez, Antonio Costanzo et al. · Journal of the American Academy of Dermatology · 2017 · 137 citations · Full text

, , +13

Telerehabilitation for chronic respiratory disease: a randomised controlled equivalence trial

Narelle S. Cox, Christine F. McDonald, Ajay Mahal et al. · Thorax · 2021 · 102 citations · Full text

, , +16

Therapeutic equivalence: fallacies and falsification

Andrew Garrett · Statistics in Medicine · 2003 · 87 citations

, , +14

Similar reliability and equivalent performance of female and male mice in the open field and water‐maze place navigation task

Ann‐Kristina Fritz, Irmgard Amrein, David P Wolfer · American Journal of Medical Genetics Part C Seminars in Medical Genetics · 2017 · 80 citations · Full text

, , +13

1–5 of 23

Authors

136

  1. KT
    Kenichiro Todoroki

    University of Shizuoka, Japan

    1 publications · 14 citations

    1

    h-index

  2. AM
    Ajay Mahal

    Monash University, Australia

    1 publications · 102 citations

    1

    h-index

  3. NZ
    Nan Zhang

    Tianjin Medical University General Hospital, China

    1 publications · 137 citations

    1

    h-index

  4. NC
    Norbert Czumbel

    Semmelweis University, Hungary

    1 publications · 17 citations

    1

    h-index

  5. JW
    Jung Won Kang

    Catholic University of Korea, South Korea

    1 publications · 54 citations

    1

    h-index

1–5 of 136

Institutions

91

  1. Heidelberg University

    Heidelberg, Germany

    2 h-index

    10 publications

    270 citations

  2. United States Food and Drug Administration

    Silver Spring, United States

    2 h-index

    3 publications

    54 citations

  3. The University of Melbourne

    Melbourne, Australia

    2 h-index

    3 publications

    341 citations

  4. Amgen (United States)

    Thousand Oaks, United States

    2 h-index

    3 publications

    284 citations

  5. Samsung (South Korea)

    Seoul, South Korea

    2 h-index

    6 publications

    252 citations

  6. Sapienza University of Rome

    Rome, Italy

    1 h-index

    1 publications

    137 citations

  7. St. Luke's Medical Center

    Quezon City, Philippines

    1 h-index

    1 publications

    18 citations

  8. Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

    Budapest, Hungary

    1 h-index

    1 publications

    17 citations

1–8 of 91

Venues

  1. Journal of Biopharmaceutical Statistics

    JBS · 2 publications · 21 citations

    2

    h-index

  2. Statistics in Medicine

    2 publications · 121 citations

    2

    h-index

  3. Biometrical Journal

    2 publications · 45 citations

    2

    h-index

  4. British Journal of Clinical Pharmacology

    BJCP · 1 publications · 54 citations

    1

    h-index

  5. Health and Quality of Life Outcomes

    HQLO · 1 publications · 43 citations

    1

    h-index

1–5