Zobrazeno 1 - 7
of 7
pro vyhledávání: '"Hugo Hamel"'
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
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:
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
Autor:
Meenu Wadhwa, Hye-Na Kang, Teeranart Jivapaisarnpong, Lucia Rizka Andalucia, Carolina Damas Rocha Zarate Blades, Mary Casas Levano, Weihong Chang, Jing Yin Chew, Mumbi Bernice Chilufya, Parichard Chirachanakul, Heeyoun (Gloria) Cho, Yi O. Cho, Kyung Min Choi, Sannie Chong, Hui Ming Chua, Ali Vasheghani Farahani, Mumun Gencoglu, Mariam Raouf Wefky Ghobrial, Prasunkumar Guha, Maria-Teresa Gutierrez Lugo, Sung Bae Ha, Suna Habahbeh, Hugo Hamel, Yeosun Hong, Aleksei Iarutkin, Hyunsook Jang, Ramalingam Jayachandran, Dong-young Kim, Gi Hyun Kim, Yunjeong Kim, Hyuk-Sang Kwon, Jacob Larsen, Aileen HyoJu Lee, Jiyoung Lee, Ksenia Medvedeva, Zuma Munkombwe, IlUng Oh, Jooyoung Park, Desi Eka Putri, Jacqueline Rodgers, Sungmun Ryu, Maria Savkina, Thomas Schreitmueller, Oleh Semeniuk, Mira Seo, Yung In Shin, Jinho Shin, Shraddha Srivastava, HyeonHo Song, Suwon Song, João Tavares Neto, Teruhide Yamaguchi, Hyun-Jun (David) Youn, Minae Yun, Aziza Ahmed
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 65
The first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adopted by the WHO Expert Committee in 2018 was held in June 2019. The workshop participants recogni
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f39c6d74a8e5f100fa3fc6d54cb19b83
https://pubmed.ncbi.nlm.nih.gov/31959504
https://pubmed.ncbi.nlm.nih.gov/31959504
Autor:
Rauza Volkova, Jayoung Jeong, Byoungguk Kim, Teruhide Yamaguchi, Beverley Alway, Tzer Jing Seng, Kyung Won Seo, Carolina Damas Rocha Zarate Blades, Jinho Shin, Jacqueline Rodgers, Mai Allam, Zuma Munkombwe, Wei Wei, Heidi Meyer, Jaeho Jung, Patricia Aprea, Elwyn Griffiths, Teeranart Jivapaisarnpong, Daecheol Kim, Yujin Jung, Sundar Ramanan, Eduardo Spitzer, Hugo Hamel, Parichard Chirachanakul, Thomas Schreitmueller, Soo Kyung Suh, Hye-Na Kang, Meenu Wadhwa, Sannie Chong, Suwon Song, Yeowon Sohn, Hea Jeong Doh, Songmei Xie, Martin Schiestl, Juliati Dahlan, Kwang-Seok Seo, Ilung Oh
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 52
In April 2017, WHO convened an informal consultation to develop WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products. The objective of the meeting was to review the draft of WHO guidelines and the comment
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9e1aa08769e80e5ee1f6d17b3f741f6a
https://pubmed.ncbi.nlm.nih.gov/29289489
https://pubmed.ncbi.nlm.nih.gov/29289489
Autor:
Pierre Russo, Jean-Marie Leclerc, George-Etienne Rivard, Hugo Hamel, Martin A. Champagne, Mark L. Bernstein, Emile Levy, Wagner V. Yotov
Publikováno v:
Genes, Chromosomes and Cancer. 26:62-69
We studied the involvement of PRIM1 in osteosarcoma by differential display, Northern and Southern hybridization, as well as fluorescence in situ hybridization (FISH) on interphase nuclei. In total, 22 pediatric oncology specimens were tested. PRIM1
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4dac3f688d3ac5ef1190092313c94cc9
https://doi.org/10.1002/(sici)1098-2264(199909)26:1<62::aid-gcc9>3.0.co
https://doi.org/10.1002/(sici)1098-2264(199909)26:1<62::aid-gcc9>3.0.co
Publikováno v:
Genomics. 43(3)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ea53e968f37863b42a1480733874e821
https://pubmed.ncbi.nlm.nih.gov/9268648
https://pubmed.ncbi.nlm.nih.gov/9268648