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Biologicals : Journal of the International Association of Biological Standardization
|
September 2, 2011
Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010)
Hye-Na Kang
Bulletin of the World Health Organization
|
April 27, 2018
Regulatory evaluation of biosimilars throughout their product life-cycle
Hye-Na Kang, Ivana Knezevic
Biologicals : Journal of the International Association of Biological Standardization
|
November 1, 2019
Quality changes to approved biotherapeutic product: Simulated case studies on reporting categories & supporting data requirements
Hugo Hamel, Hye-Na Kang
Biologicals : Journal of the International Association of Biological Standardization
|
April 1, 2020
The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019
Hye-Na Kang, Robin Thorpe, Ivana Knezevic, et al.
Biologicals : Journal of the International Association of Biological Standardization
|
July 30, 2015
Immunogenicity assessment of monoclonal antibody products: A simulated case study correlating antibody induction with clinical outcomes
Ivana Knezevic, Hye-Na Kang, Robin Thorpe
Biologicals : Journal of the International Association of Biological Standardization
|
December 4, 2014
Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval
Alex Kudrin, Ivana Knezevic, Jeewon Joung, et al.
Biologicals : Journal of the International Association of Biological Standardization
|
July 7, 2015
Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility
Meenu Wadhwa, Ivana Knezevic, Hye-Na Kang, et al.
Biologicals : Journal of the International Association of Biological Standardization
|
November 1, 2019
Quality assessment and its impact on clinical performance of a biosimilar erythropoietin: A simulated case study
Robin Thorpe, Gustavo Grampp, Hye-Na Kang, et al.
NPJ Vaccines
|
June 25, 2020
WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019
Rebecca Sheets, Hye-Na Kang, Heidi Meyer, et al.
Biologicals : Journal of the International Association of Biological Standardization
|
January 1, 2018
WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 27-28 April 2017
Meenu Wadhwa, Hye-Na Kang, Hugo Hamel, et al.
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of 3
Search research articles
Search
Showing results (1-10 of 26) with videos related to
Sort By:
Page
of 3
Biologicals : Journal of the International Association of Biological Standardization
|
September 2, 2011
Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010)
Hye-Na Kang
Bulletin of the World Health Organization
|
April 27, 2018
Regulatory evaluation of biosimilars throughout their product life-cycle
Hye-Na Kang, Ivana Knezevic
Biologicals : Journal of the International Association of Biological Standardization
|
November 1, 2019
Quality changes to approved biotherapeutic product: Simulated case studies on reporting categories & supporting data requirements
Hugo Hamel, Hye-Na Kang
Biologicals : Journal of the International Association of Biological Standardization
|
April 1, 2020
The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019
Hye-Na Kang, Robin Thorpe, Ivana Knezevic, et al.
Biologicals : Journal of the International Association of Biological Standardization
|
July 30, 2015
Immunogenicity assessment of monoclonal antibody products: A simulated case study correlating antibody induction with clinical outcomes
Ivana Knezevic, Hye-Na Kang, Robin Thorpe
Biologicals : Journal of the International Association of Biological Standardization
|
December 4, 2014
Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval
Alex Kudrin, Ivana Knezevic, Jeewon Joung, et al.
Biologicals : Journal of the International Association of Biological Standardization
|
July 7, 2015
Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility
Meenu Wadhwa, Ivana Knezevic, Hye-Na Kang, et al.
Biologicals : Journal of the International Association of Biological Standardization
|
November 1, 2019
Quality assessment and its impact on clinical performance of a biosimilar erythropoietin: A simulated case study
Robin Thorpe, Gustavo Grampp, Hye-Na Kang, et al.
NPJ Vaccines
|
June 25, 2020
WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019
Rebecca Sheets, Hye-Na Kang, Heidi Meyer, et al.
Biologicals : Journal of the International Association of Biological Standardization
|
January 1, 2018
WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 27-28 April 2017
Meenu Wadhwa, Hye-Na Kang, Hugo Hamel, et al.
Page
of 3