Concepedia

Release Criteria

Release Criteria is a predefined set of product specifications and associated acceptance parameters for a cell therapy product that each manufactured lot must satisfy—typically including validated measures of identity, purity, potency, safety, and overall quality—in order to be formally released from manufacturing control for clinical use.

66

Publications

2.8K

Citations

251

Authors

117

Institutions

Publications per year

2017–2026

8

Variants

Release Specifications

Parents

Children

Publications

66

Physicochemical properties and mechanism of drug release from ethyl cellulose matrix tablets prepared by direct compression and hot-melt extrusion

Michael M. Crowley, Britta Schroeder, Anke Fredersdorf et al. · International Journal of Pharmaceutics · 2003 · 254 citations

, , +16

Identification and validation of multiple cell surface markers of clinical-grade adipose-derived mesenchymal stromal cells as novel release criteria for good manufacturing practice-compliant production

Emily T. Camilleri, Michael P. Gustafson, Amel Dudakovic et al. · Stem Cell Research & Therapy · 2016 · 241 citations · Full text

, , +16

Elevated temperature accelerated release testing of PLGA microspheres

Banu S. Zolnik, Pauline E. Leary, Diane J. Burgess · Journal of Controlled Release · 2006 · 229 citations

, , +13

Release Planning in Market-Driven Software Product Development: Provoking an Understanding

Requirements Engineering · 2002 · 200 citations

, , +14

Development and evaluation of sustained release mini-matrices prepared via hot melt extrusion

C De Brabander, Chris Vervaet, J.P. Remon · Journal of Controlled Release · 2003 · 113 citations

, , +11

1–5 of 66

Authors

251

  1. GR
    Guenther Ruhe

    University of Calgary, Canada

    4 publications · 90 citations

    4

    h-index

  2. DJ
    Diane J. Burgess

    University of Connecticut, United States

    4 publications · 347 citations

    4

    h-index

  3. FS
    F. Serdoz

    University of Trieste, Italy

    2 publications · 63 citations

    2

    h-index

  4. SC
    Stephanie Choi

    Center for Drug Evaluation and Research, United States

    2 publications · 98 citations

    2

    h-index

  5. CV
    Chris Vervaet

    Ghent University, Belgium

    2 publications · 207 citations

    2

    h-index

1–5 of 251

Institutions

117

  1. University of Connecticut

    Storrs, United States

    4 h-index

    8 publications

    694 citations

  2. University of Calgary

    Calgary, Canada

    4 h-index

    11 publications

    253 citations

  3. Center for Drug Evaluation and Research

    Silver Spring, United States

    3 h-index

    5 publications

    146 citations

  4. United States Food and Drug Administration

    Silver Spring, United States

    3 h-index

    6 publications

    364 citations

  5. National University of Singapore

    Singapore, Singapore

    2 h-index

    3 publications

    271 citations

  6. Ghent University

    Ghent, Belgium

    2 h-index

    7 publications

    715 citations

  7. Rhodes University

    Grahamstown, South Africa

    2 h-index

    3 publications

    82 citations

  8. University of Alberta

    Edmonton, Canada

    2 h-index

    3 publications

    74 citations

1–8 of 117

Venues

  1. International Journal of Pharmaceutics

    9 publications · 571 citations

    9

    h-index

  2. 3

    h-index

  3. Journal of Controlled Release

    3 publications · 422 citations

    3

    h-index

  4. AAPS PharmSciTech

    2 publications · 100 citations

    2

    h-index

  5. Journal of Pharmaceutical Sciences

    2 publications · 26 citations

    2

    h-index

1–5