Concepedia

Dissolution Test Method Validation

Dissolution Test Method Validation is the process of establishing documented evidence that a dissolution test method, under actual or simulated use conditions, consistently measures the rate and extent of drug release from a dosage form with accuracy, precision, specificity, and robustness appropriate for its intended purpose in quality control.

272

Publications

8.6K

Citations

1K

Authors

309

Institutions

Publications per year

2017–2026

55

Parents

Publications

272

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

Cellulose in lithium chloride/N,N-dimethylacetamide, optimisation of a dissolution method using paper substrates and stability of the solutions

Anne‐Laurence Dupont · Polymer · 2003 · 217 citations · Full text

, , +13

An alternative method to the evaluation of similarity factor in dissolution testing

Paulo Costa · International Journal of Pharmaceutics · 2001 · 197 citations

, , +6

Analytical method validation and instrument performance verification

Chung Chow Chan · 2004 · 169 citations

, , +16

In vivo in vitro correlations for a poorly soluble drug, danazol, using the flow-through dissolution method with biorelevant dissolution media

Vibeke Hougaard Sunesen, Betty Lomstein Pedersen, Henning Gjelstrup Kristensen et al. · European Journal of Pharmaceutical Sciences · 2005 · 169 citations

, , +17

1–5 of 272

Authors

1K

  1. JD
    Jennifer Dressman

    Goethe University Frankfurt, Germany

    7 publications · 292 citations

    7

    h-index

  2. MS
    Martin Siewert

    Zentrallaboratorium Deutscher Apotheker, Germany

    6 publications · 198 citations

    6

    h-index

  3. VP
    Valéria Pereira de Sousa

    Universidade Federal do Rio de Janeiro, Brazil

    6 publications · 115 citations

    6

    h-index

  4. VP
    Vinod P. Shah

    Center for Drug Evaluation and Research, United States

    6 publications · 296 citations

    6

    h-index

  5. WB
    William B. Furman

    United States Food and Drug Administration, United States

    6 publications · 141 citations

    6

    h-index

1–5 of 1K

Institutions

309

  1. Universidade Federal do Rio Grande do Sul

    Porto Alegre, Brazil

    10 h-index

    37 publications

    892 citations

  2. United States Food and Drug Administration

    Silver Spring, United States

    10 h-index

    24 publications

    1.5K citations

  3. Center for Drug Evaluation and Research

    Silver Spring, United States

    9 h-index

    36 publications

    2.4K citations

  4. United States Pharmacopeial Convention

    Rockville, United States

    8 h-index

    43 publications

    800 citations

  5. Universidade Federal do Rio de Janeiro

    Rio de Janeiro, Brazil

    6 h-index

    24 publications

    437 citations

  6. Pfizer (United States)

    New York, United States

    5 h-index

    13 publications

    355 citations

  7. Eli Lilly (United States)

    Indianapolis, United States

    5 h-index

    7 publications

    392 citations

  8. AbbVie (United States)

    North Chicago, United States

    5 h-index

    15 publications

    551 citations

1–8 of 309

Venues

  1. Dissolution Technologies

    37 publications · 1.1K citations

    19

    h-index

  2. Journal of Pharmaceutical Sciences

    25 publications · 734 citations

    17

    h-index

  3. International Journal of Pharmaceutics

    18 publications · 748 citations

    15

    h-index

  4. 14

    h-index

  5. European Journal of Pharmaceutical Sciences

    12 publications · 682 citations

    12

    h-index

1–5