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Hye-Na Kang

Showing results (1-10 of 26) with videos related to

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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-cycleHye-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 requirementsHugo 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 2019Hye-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 outcomesIvana 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 approvalAlex 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 utilityMeenu 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 studyRobin 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 2019Rebecca 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 2017Meenu Wadhwa, Hye-Na Kang, Hugo Hamel, et al.
Pageof 3

Showing results (1-10 of 26) with videos related to

Sort By:
Pageof 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-cycleHye-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 requirementsHugo 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 2019Hye-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 outcomesIvana 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 approvalAlex 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 utilityMeenu 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 studyRobin 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 2019Rebecca 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 2017Meenu Wadhwa, Hye-Na Kang, Hugo Hamel, et al.
Pageof 3