Concepedia

Comparability Studies

Comparability Studies is a systematic scientific assessment used to demonstrate that changes in cell therapy manufacturing processes, particularly within single-use bioprocessing systems, do not adversely impact product quality, safety, or efficacy, by establishing a high degree of similarity between pre- and post-change materials based on comprehensive analytical and functional data.

59

Publications

2.9K

Citations

269

Authors

143

Institutions

Publications per year

2017–2026

15

Parents

Publications

59

The Utility of Hydrogen/Deuterium Exchange Mass Spectrometry in Biopharmaceutical Comparability Studies

Damian J. Houde, Steven A. Berkowitz, John R. Engen · Journal of Pharmaceutical Sciences · 2010 · 383 citations

, , +14

Characterizing biological products and assessing comparability following manufacturing changes

Arthur J. Chirino, Anthony R. Mire‐Sluis · Nature Biotechnology · 2004 · 364 citations

, , +14

Comparability of a paper-based language test and a computer-based language test

Inn-Chull Choi, Kyoung Sung Kim, Jaeyool Boo · Language Testing · 2003 · 157 citations

, , +17

Global Comparability in Financial Reporting: What, Why, How, and When?

Mary E. Barth · China Journal of Accounting Studies · 2013 · 103 citations

, , +17

An Inductive-Coupled Plasma Atomic-Emission Spectrometric Method for Routine Water Quality Testing

John R. Garbarino, H. E. Taylor · Applied Spectroscopy · 1979 · 99 citations

, , +17

1–5 of 59

Authors

269

  1. AS
    Anurag S. Rathore

    Indian Institute of Technology Delhi, India

    2 publications · 48 citations

    2

    h-index

  2. SJ
    Sarah J. Schrieber

    Center for Drug Evaluation and Research, United States

    2 publications · 22 citations

    2

    h-index

  3. JR
    J. Richard Hebel

    University of Maryland, Baltimore, United States

    2 publications · 173 citations

    2

    h-index

  4. JR
    John R. Engen

    Northeastern University, United States

    2 publications · 441 citations

    2

    h-index

  5. SS
    Susan Spear Bassett

    Johns Hopkins University, United States

    2 publications · 173 citations

    2

    h-index

1–5 of 269

Institutions

143

  1. Center for Drug Evaluation and Research

    Silver Spring, United States

    3 h-index

    19 publications

    552 citations

  2. University College London

    London, United Kingdom

    3 h-index

    6 publications

    218 citations

  3. Cell Therapy Catapult

    London, United Kingdom

    2 h-index

    5 publications

    145 citations

  4. National Institute for Biological Standards and Control

    Potters Bar, United Kingdom

    2 h-index

    7 publications

    174 citations

  5. Material Measurement Laboratory

    Gaithersburg, United States

    2 h-index

    4 publications

    192 citations

  6. University of Trento

    Trento, Italy

    2 h-index

    2 publications

    45 citations

  7. Medical Research Council

    London, United Kingdom

    2 h-index

    2 publications

    55 citations

  8. Health Canada

    Ottawa, Canada

    2 h-index

    6 publications

    272 citations

1–8 of 143

Venues

  1. China Journal of Accounting Studies

    CJAS · 3 publications · 147 citations

    3

    h-index

  2. Psychology and Aging

    2 publications · 173 citations

    2

    h-index

  3. Journal of Pharmaceutical Sciences

    2 publications · 402 citations

    2

    h-index

  4. 2

    h-index

  5. Pharmaceuticals

    1 publications · 20 citations

    1

    h-index

1–5