Zobrazeno 1 - 10
of 28
pro vyhledávání: '"Hye Na Kang"'
Publikováno v:
Annals of the New York Academy of Sciences. 1521:96-103
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::e141e4cf262a9afc1dde91d7b6e6c187
https://doi.org/10.1111/nyas.14965
https://doi.org/10.1111/nyas.14965
Publikováno v:
Vaccines, Vol 9, Iss 2, p 81 (2021)
The global research and development of mRNA vaccines have been prodigious over the past decade, and the work in this field has been stimulated by the urgent need for rapid development of vaccines in response to an emergent disease such as the current
Externí odkaz:
https://doaj.org/article/c62bf85d987448069e208dcebf5c1814
Autor:
Hye-Na Kang, Robin Thorpe, Ivana Knezevic, Daehyun Baek, Parichard Chirachanakul, Hui Ming Chua, Dina Dalili, Freddie Foo, Kai Gao, Suna Habahbeh, Hugo Hamel, Edwin Nkansah, Maria Savkina, Oleh Semeniuk, Shraddha Srivastava, João Tavares Neto, Meenu Wadhwa, Teruhide Yamaguchi
Publikováno v:
Generics and Biosimilars Initiative Journal. 10:4-32
The World Health Organization has provided specific guidance for biosimilar products to assist regulators, manufacturers and other professionals involved in the development and evaluation of these products. The development and approval of biosimilars
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8a7b705e466e297bc0b6dd8c2ec8073b
https://doi.org/10.5639/gabij.2021.1001.002
https://doi.org/10.5639/gabij.2021.1001.002
Publikováno v:
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy. 36(3)
The World Health Organization (WHO) guidelines on evaluation of similar biotherapeutic products (SBPs; also called biosimilars) were adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2009. In 2019, the ECBS considered that a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4c8272bf7a9ba939909aad390cba345e
https://pubmed.ncbi.nlm.nih.gov/35596890
https://pubmed.ncbi.nlm.nih.gov/35596890
Autor:
Hui Ming Chua, Mumbi Bernice Chilufya, Parichard Chirachanakul, Jacqueline Rodgers, Maria Savkina, Kai Gao, Hugo Hamel, Violeta Pérez Rodríguez, Suna Habahbeh, João Tavares Neto, Mary Casas Levano, Teruhide Yamaguchi, Hye Na Kang, Gi Hyun Kim, Dina Dalili, Freddie Foo, Oleh Semeniuk, Robin Thorpe, Desi Eka Putri, Ivana Knezevic, Shraddha Srivastava, Meenu Wadhwa
Publikováno v:
Annals of the New York Academy of Sciences
The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory p
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6cb8365299a9c97b698ae2a9e92bed8a
https://doi.org/10.1111/nyas.14522
https://doi.org/10.1111/nyas.14522
Autor:
Meenu Wadhwa, Hye-Na Kang, Robin Thorpe, Ivana Knezevic, P. Aprea, M.-C. Bielsky, N. Ekman, H.-K. Heim, J. Joung, P. Kurki, E. Lacana, C. Njue, E. Nkansah, M. Savkina, R. Thorpe, T. Yamaguchi, M. Wadhwa, J. Wang, M. Weise, E. Wolff-Holz, M. Allam, H. Bahaa, M. Sayed, A. Al-Oballi, A. Alshahrani, D. Baek, J. Kim, H.M. Chua, J. Gangakhedkar, Mr P. Jagtap, T. Lyaskovsky, S. Okudaira, W. Ondee, P.S. Sotomayor, J.I. Solis Ricra, J. Uviase, F. Ahmed, Y. Rajendran, H.G. Tonioli Defendi, S.Yi O. Cho, A. Qu, V. Acha, M. Gencoglu, K. Ho, M. Baldrighi, M. Schiestl, K. Watson, E. Spitzer, S. Chong, A. Fukushima, H.-N. Kang, I. Knezevic, G. Pante, Mariangela Simao
Publikováno v:
Biologicals, 76:1-9
Publisher Copyright: © 2022 The WHO informal consultation was held to promote the revision of WHO guidelines on evaluation of similar biotherapeutic products (SBPs) adopted by the Expert Committee on Biological Standardization (ECBS) in 2009. It was
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a1d0247b0f77d1c7c1607f493ec41ffc
https://repository.publisso.de/resource/frl:6433668
https://repository.publisso.de/resource/frl:6433668
Autor:
Hye-Na Kang, Hugo Hamel
Publikováno v:
Biologicals
Changes are essential for the continual improvement of the manufacturing process and for maintaining state-of-the-art controls on biotherapeutic products and such changes often need to be implemented after the product has been approved. WHO guideline
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::709cf015aee9527484719d7064414e22
https://doi.org/10.1016/j.biologicals.2019.10.008
https://doi.org/10.1016/j.biologicals.2019.10.008
Publikováno v:
Vaccines
Volume 9
Issue 2
Vaccines, Vol 9, Iss 81, p 81 (2021)
Volume 9
Issue 2
Vaccines, Vol 9, Iss 81, p 81 (2021)
The global research and development of mRNA vaccines have been prodigious over the past decade, and the work in this field has been stimulated by the urgent need for rapid development of vaccines in response to an emergent disease such as the current
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d98ff67b630969724662fa7824f42d31
https://pubmed.ncbi.nlm.nih.gov/33498787
https://pubmed.ncbi.nlm.nih.gov/33498787
Autor:
Rebecca Sheets, Hye-Na Kang, Heidi Meyer, Ivana Knezevic, WHO informal consultation on development of guidelines for assuring the quality, safety, and efficacy of DNA vaccine
Publikováno v:
NPJ Vaccines
npj Vaccines, Vol 5, Iss 1, Pp 1-5 (2020)
npj Vaccines, Vol 5, Iss 1, Pp 1-5 (2020)
Consultations have been held to promote the revision of the WHO guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines adopted by the Expert Committee on Biological Standardization (ECBS) in 2005. The drivers for this r
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2894a4d9810a316777da1fe19ad695cc
http://europepmc.org/articles/PMC7303131
http://europepmc.org/articles/PMC7303131