Concepedia

Dissolution Testing For Bioequivalence

Dissolution Testing for Bioequivalence is a pharmaceutical analytical method that evaluates the rate and extent of drug release from a dosage form under standardized conditions to establish in vitro equivalence as a surrogate for in vivo bioequivalence in regulatory approval of generic drug products.

116

Publications

3.4K

Citations

503

Authors

174

Institutions

Publications per year

2017–2026

41

Parents

Publications

116

Dissolution Testing for Generic Drugs: An FDA Perspective

Om Anand, Lawrence X. Yu, Dale P. Conner et al. · The AAPS Journal · 2011 · 270 citations · Full text

, , +14

fDA Guidance for Industry 1 Dissolution Testing of Immediate Release Solid Oral Dosage Forms

Vinod P. Shah, Lawrence J. Lesko, Jim Fan et al. · Dissolution Technologies · 1997 · 147 citations · Full text

, , +17

Dissolution, Bioavailability and Bioequivalence

Hammed M. Abdou · Drug Development and Industrial Pharmacy · 1990 · 141 citations

, , +10

In Vitro–In Vivo Correlation: Importance of Dissolution in IVIVC

J-M. Cardot, Eric Beyssac, Monique Alric · Dissolution Technologies · 2007 · 137 citations · Full text

, , +17

Dynamic Dissolution Testing To Establish In Vitro/In Vivo Correlations for Montelukast Sodium, a Poorly Soluble Drug

Arthur Okumu, Marie DiMaso, Raimar Löbenberg · Pharmaceutical Research · 2008 · 112 citations

, , +17

1–5 of 116

Authors

503

  1. AG
    Alfredo García‐Arieta

    Agencia Española de Medicamentos y Productos Sanitarios, Spain

    9 publications · 281 citations

    9

    h-index

  2. MB
    Marival Bermejo

    Universitat de Miguel Hernández d'Elx, Spain

    6 publications · 141 citations

    7

    h-index

  3. IG
    Isabel González‐Álvarez

    Universitat de Miguel Hernández d'Elx, Spain

    5 publications · 122 citations

    6

    h-index

  4. MG
    Marta González‐Álvarez

    Universitat de València, Spain

    5 publications · 122 citations

    5

    h-index

  5. VP
    Vinod P. Shah

    Center for Drug Evaluation and Research, United States

    5 publications · 255 citations

    5

    h-index

1–5 of 503

Institutions

174

  1. Center for Drug Evaluation and Research

    Silver Spring, United States

    8 h-index

    16 publications

    1.5K citations

  2. Universitat de Miguel Hernández d'Elx

    Elche, Spain

    7 h-index

    29 publications

    731 citations

  3. United States Food and Drug Administration

    Silver Spring, United States

    6 h-index

    19 publications

    1.6K citations

  4. GlaxoSmithKline (United States)

    Philadelphia, United States

    4 h-index

    5 publications

    87 citations

  5. Janssen (Belgium)

    Beerse, Belgium

    4 h-index

    6 publications

    100 citations

  6. Universitat de València

    Valencia, Spain

    4 h-index

    5 publications

    123 citations

  7. University of Michigan

    Ann Arbor, United States

    4 h-index

    10 publications

    342 citations

  8. Agencia Española de Medicamentos y Productos Sanitarios

    Madrid, Spain

    4 h-index

    4 publications

    153 citations

1–8 of 174

Venues

  1. Dissolution Technologies

    16 publications · 564 citations

    13

    h-index

  2. The AAPS Journal

    AAPSJ · 7 publications · 387 citations

    8

    h-index

  3. Pharmaceutics

    6 publications · 110 citations

    8

    h-index

  4. Molecular Pharmaceutics

    5 publications · 135 citations

    6

    h-index

  5. PubMed

    Repository · 5 publications · 118 citations

    5

    h-index

1–5