Concepedia

Multi-source Reference Product Comparison

Multi-Source Reference Product Comparison is a methodological framework within pharmaceutical regulatory science that systematically evaluates and contrasts reference-listed drugs across multiple authoritative sources to identify discrepancies, ensure consistency, and establish the most appropriate reference product for generic drug development and regulatory approval.

4

Publications

90

Citations

25

Authors

18

Institutions

Publications per year

2017–2026

2

Parents

Publications

4

Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop summary report

Mei‐Ling Chen, Vinod P. Shah, Daan J.A. Crommelin et al. · European Journal of Pharmaceutical Sciences · 2011 · 26 citations

, , +15

Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment

Jae Hee Lee, Kyungyeol Paek, Jae Hyon Moon et al. · BioDrugs · 2019 · 24 citations · Full text

, , +14

Letter--Draft FDA Guidance “Considerations in Demonstrating Interchangeability with a Reference Product”: Overview and Presentation-Related Concerns

Elan Rubinstein · Journal of Managed Care & Specialty Pharmacy · 2017 · 23 citations · Full text

, , +16

Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop Summary Report

Mei‐Ling Chen, Vinod P. Shah, Daan J.A. Crommelin et al. · The AAPS Journal · 2011 · 17 citations

, , +15

1–4 of 4

Authors

25

  1. MC
    Mei‐Ling Chen

    University of British Columbia, Canada

    2 publications · 43 citations

    2

    h-index

  2. VP
    Vinod P. Shah

    Center for Drug Evaluation and Research, United States

    2 publications · 43 citations

    2

    h-index

  3. DB
    Dennis Bashaw

    Goethe University Frankfurt, Germany

    2 publications · 43 citations

    2

    h-index

  4. JM
    José Morais

    Université Libre de Bruxelles, Belgium

    2 publications · 43 citations

    2

    h-index

  5. EO
    Eric Ormsby

    Health Canada, Canada

    2 publications · 43 citations

    2

    h-index

1–5 of 25

Institutions

18

  1. Teva Pharmaceuticals (United States)

    North Wales, United States

    2 h-index

    2 publications

    43 citations

  2. Eisai (United States)

    Woodcliff Lake, United States

    2 h-index

    2 publications

    43 citations

  3. Goethe University Frankfurt

    Frankfurt am Main, Germany

    2 h-index

    2 publications

    43 citations

  4. SocraTec R&D (Germany)

    Erfurt, Germany

    2 h-index

    2 publications

    43 citations

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

    Rahway, United States

    2 h-index

    2 publications

    43 citations

  6. Apotex (Canada)

    Toronto, Canada

    2 h-index

    2 publications

    43 citations

  7. Thomas Jefferson University

    Philadelphia, United States

    2 h-index

    2 publications

    43 citations

  8. International Pharmaceutical Federation

    The Hague, Netherlands

    2 h-index

    2 publications

    43 citations

1–8 of 18

Venues

  1. The AAPS Journal

    AAPSJ · 1 publications · 17 citations

    1

    h-index

  2. European Journal of Pharmaceutical Sciences

    1 publications · 26 citations

    1

    h-index

  3. BioDrugs

    1 publications · 24 citations

    1

    h-index

  4. Journal of Managed Care & Specialty Pharmacy

    JMCP · 1 publications · 23 citations

    1

    h-index

1–4