Jeewon Joung
Overview
Explore the profile of Jeewon Joung including associated specialties, affiliations and a list of published articles.
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Articles
7
Citations
34
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0
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Recent Articles
1.
Kwon O, Joung J, Park Y, Kim C, Hong S
Biologicals
. 2017 May;
48:101-108.
PMID: 28495312
Based on experience in clinical trial approvals and marketing authorizations for biosimilar products in Korea, we suggest principles for the analytical comparability assessment of biosimilar products with respect to regulatory...
2.
Hayakawa T, Harris I, Joung J, Kanai N, Kawamata S, Kellathur S, et al.
Biologicals
. 2016 Jul;
44(5):467-79.
PMID: 27461129
The development of human cell therapy and gene therapy products has progressed internationally. Efforts have been made to address regulatory challenges in the evaluation of quality, efficacy, and safety of...
3.
Kudrin A, Knezevic I, Joung J, Kang H
Biologicals
. 2014 Dec;
43(1):1-10.
PMID: 25467836
The objective of this paper is to provide considerations based on comprehensive case studies important for regulatory evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) with a special emphasis...
4.
Schiestl M, Li J, Abas A, Vallin A, Millband J, Gao K, et al.
Biologicals
. 2013 Dec;
42(2):128-32.
PMID: 24373974
A determination of biosimilarity is based on a thorough characterization and comparison of the quality profiles of a similar biotherapeutic product and its reference biotherapeutic product. Although the general principles...
5.
Oh H, Joung J, Kim B, Nam K, Hong S, Song H, et al.
Vaccine
. 2012 Oct;
30(50):7246-52.
PMID: 23084771
The histamine sensitization test is a widely used method for measuring the residual toxicity of pertussis toxin in acellular pertussis vaccines. Although it has been used as a routine assay...
6.
Oh H, Joung J, Kim B, Lee H, Lee W, Hong S, et al.
Hum Vaccin Immunother
. 2012 Apr;
8(6):783-7.
PMID: 22508413
Specific toxicity test is a major quality control test for acellular pertussis (aP) vaccines performed by manufacturers and regulatory authorities. The 'mouse body weight gain test (MWGT)', the 'leukocytosis-promoting test...
7.
Joung J, Robertson J, Griffiths E, Knezevic I
Biologicals
. 2008 Jan;
36(4):269-76.
PMID: 18218324
This report reflects the discussion and conclusions of an informal consultation held on 19-20 April 2007 at the World Health Organization concerning the regulatory evaluation of therapeutic biological medicinal products....