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收藏Regulatory challenges with biosimilars: an update from 20 countries生物仿制药的监管挑战: 来自20个国家的最新情况
Kang, Hye-Na; Thorpe, Robin; Knezevic, Ivana; Casas Levano, Mary; Chilufya, Mumbi Bernice; Chirachanakul, Parichard; Chua, Hui Ming; Dalili, Dina; Foo, Freddie; Gao, Kai; Habahbeh, Suna; Hamel, Hugo; Kim, Gi Hyun; Perez Rodriguez, Violeta; Putri, Desi Eka; Rodgers, Jacqueline; Savkina, Maria; Semeniuk, Oleh; Srivastava, Shraddha; Tavares Neto, Joao; Wadhwa, Meenu; Yamaguchi, Teruhide
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收藏Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs
Civoli, Francesca; Kasinath, Aparna; Cai, Xiao-Yan; Wadhwa, Meenu; Exley, Andrew; Oldfield, Philip; Alvandkouhi, Safa; Schaffar, Gregor; Chappell, John; Bowsher, Ronald; Devanarayan, Viswanath; Marini, Joseph; Rebarchak, Shannon; Anderson, Michael; Koppenburg, Vera; Lester, Todd
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收藏The first World Health Organization International Standard for infliximab products: A step towards maintaining harmonized biological activity
Metcalfe, Clive; Dougall, Thomas; Bird, Chris; Rigsby, Peter; Behr-Gross, Marie-Emmanuelle; Wadhwa, Meenu; Morris, Melanie; Hogie, Lea-Ellen; Mortimer, Keith; Wang, Haibin; Li, Lei; Hao, Bingjie; Li, Meng; Wang, Lan; Vesterinen, Jaana; Jorajuria, Sylvie; Behr-Gross, Marie-Emmanuelle; Ourlin, Jean-Claude; Tovey, Michael; Lallemand, Christophe; Herbrand, Ulrike; Brack, Kerstin; Khedkar, Shubrata; Munagala, Prabhavathy; Chakrabarti, Ranjan; Mulugeta, Ezra; Mark, Charlotta; Fritsch, Cornelius; Puljic, Ruzica; Bird, Chris; Dilger, Paula; Metcalfe, Clive; Dunn, Stuart; Wu, Guoping; Geders, Todd; Yang, Yong Suk; Jang, Gye Mee; Yang, Jia-Ming; Peng, Yucai; Shibata, Hiroko; Kiyoshi, Masato; Ishii-Watabe, Akiko; Hong, Yeonjoo; Dushek, Omer; Bridge, Marcus; Nguyen, John; Lin, Chaomei; Albanese, Joseph; Geurts, Ton; Kessels, James; Berghmans, Raf; de Vries, Annick; Lourens, Tom; Nagore, Daniel; Catarino, Susana; Snyder, Melissa; Willrich, Maria; Arkir, Zehra; Parussini, Ermis; Daviere, Simon
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