Concepedia

Release Testing Criteria

Release Testing Criteria is a regulatory quality control framework that specifies the minimum standards and analytical requirements a gene therapy product must meet prior to release for clinical use, distinguishing it from other regulatory assessments by focusing exclusively on batch-specific safety, purity, potency, and identity attributes verified through validated testing methods.

10

Publications

272

Citations

57

Authors

25

Institutions

Publications per year

2017–2026

2

Parents

Publications

10

Large-Scale Clinical Expansion of Mesenchymal Stem Cells in the GMP-Compliant, Closed Automated Quantum® Cell Expansion System: Comparison with Expansion in Traditional T-Flasks

Chantal Lechanteur · Journal of Stem Cell Research & Therapy · 2014 · 49 citations · Full text

, , +17

Development of cultured Plasmodium falciparum blood-stage malaria cell banks for early phase in vivo clinical trial assessment of anti-malaria drugs and vaccines

Danielle I. Stanisic, Xue Q. Liu, Sai Lata De et al. · Malaria Journal · 2015 · 46 citations · Full text

, , +17

Hematologic Parameters in Raptor Species in a Rehabilitation Setting Before Release

Peter A. Black, David McRuer, Leigh-Ann Horne · Journal of Avian Medicine and Surgery · 2011 · 32 citations

, , +16

Vergence Orthoptics: Validity and Persistence of the Training Effect

J. David Grisham, MARK C. BOWMAN, LEIGH A. OWYANG et al. · Optometry and Vision Science · 1991 · 30 citations

, , +16

First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes – Chapter 3: Porcine islet product manufacturing and release testing criteria

Gina R. Rayat, Lawrence S. Gazda, Wayne J. Hawthorne et al. · Xenotransplantation · 2016 · 25 citations

, , +17

1–5 of 10

Authors

57

  1. BK
    B. Kim Lee Sim

    Sanaria, United States

    1 publications · 46 citations

    1

    h-index

  2. TB
    Thejaswi Bikkani

    National Institutes of Health Clinical Center, United States

    1 publications · 21 citations

    1

    h-index

  3. PD
    Pavel Daněk

    Landscape Research Institute, Czechia

    1 publications · 16 citations

    1

    h-index

  4. SM
    Shinichi Matsumoto

    Baylor University, United States

    1 publications · 25 citations

    1

    h-index

  5. MF
    Michael F. Good

    QIMR Berghofer Medical Research Institute, Australia

    1 publications · 46 citations

    1

    h-index

1–5 of 57

Institutions

25

  1. University of California, Berkeley

    Berkeley, United States

    1 h-index

    4 publications

    120 citations

  2. Mendel University in Brno

    Brno, Czechia

    1 h-index

    1 publications

    16 citations

  3. The University of Sydney

    Sydney, Australia

    1 h-index

    1 publications

    25 citations

  4. National Institutes of Health Clinical Center

    Bethesda, United States

    1 h-index

    9 publications

    189 citations

  5. Institute of Radiotherapy and Nuclear Medicine

    Peshawar, Pakistan

    1 h-index

    1 publications

    14 citations

  6. QIMR Berghofer Medical Research Institute

    Brisbane, Australia

    1 h-index

    4 publications

    184 citations

  7. Griffith University

    Brisbane, Australia

    1 h-index

    7 publications

    322 citations

  8. Auckland Council

    Auckland, New Zealand

    1 h-index

    1 publications

    25 citations

1–8 of 25

Venues

  1. Radiation Protection Dosimetry

    1 publications · 14 citations

    1

    h-index

  2. First Monday

    1 publications · 19 citations

    1

    h-index

  3. Malaria Journal

    1 publications · 46 citations

    1

    h-index

  4. 1

    h-index

  5. Optometry and Vision Science

    1 publications · 30 citations

    1

    h-index

1–5