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Regulatory challenges with biosimilars: an update from 20 countries.
Kang HN, Thorpe R, Knezevic I, Casas Levano M, Chilufya MB, Chirachanakul P, Chua HM, Dalili D, Foo F, Gao K, Habahbeh S, Hamel H, Kim GH, Perez Rodriguez V, Putri DE, Rodgers J, Savkina M, Semeniuk O, Srivastava S, Tavares Neto J, Wadhwa M, Yamaguchi T. Kang HN, et al. Among authors: savkina m. Ann N Y Acad Sci. 2021 May;1491(1):42-59. doi: 10.1111/nyas.14522. Epub 2020 Nov 21. Ann N Y Acad Sci. 2021. PMID: 33222245 Free PMC article.
WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.
Wadhwa M, Kang HN, Thorpe R, Knezevic I; following participants of the WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products; Aprea P, Bielsky MC, Ekman N, Heim HK, Joung J, Kurki P, Lacana E, Njue C, Nkansah E, Savkina M, Thorpe R, Yamaguchi T, Wadhwa M, Wang J, Weise M, Wolff-Holz E; Other participants; Representatives of the Developing Countries Vaccine Manufacturers Network; Representatives of the Emerging Biopharmaceutical Manufacturers Network; Representatives of the IFPMA; Representatives of IGBA; Representative of the Latin American Association of Pharmaceutical Industries; Representative of the Singapore Association of Pharmaceutical Industries; WHO Secretariat. Wadhwa M, et al. Among authors: savkina m. Biologicals. 2022 Apr;76:1-9. doi: 10.1016/j.biologicals.2022.03.001. Epub 2022 Apr 22. Biologicals. 2022. PMID: 35466023 Free PMC article.
Structural basis of transcription inhibition by antibiotic streptolydigin.
Temiakov D, Zenkin N, Vassylyeva MN, Perederina A, Tahirov TH, Kashkina E, Savkina M, Zorov S, Nikiforov V, Igarashi N, Matsugaki N, Wakatsuki S, Severinov K, Vassylyev DG. Temiakov D, et al. Among authors: savkina m. Mol Cell. 2005 Sep 2;19(5):655-66. doi: 10.1016/j.molcel.2005.07.020. Mol Cell. 2005. PMID: 16167380 Free article.
WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.
Wadhwa M, Kang HN, Jivapaisarnpong T; WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products; Andalucia LR, Blades CDRZ, Casas Levano M, Chang W, Chew JY, Chilufya MB, Chirachanakul P, Cho HG, Cho YO, Choi KM, Chong S, Chua HM, Farahani AV, Gencoglu M, Ghobrial MRW, Guha P, Gutierrez Lugo MT, Ha SB, Habahbeh S, Hamel H, Hong Y, Iarutkin A, Jang H, Jayachandran R, Jivapaisarnpong T, Kang HN, Kim DY, Kim GH, Kim Y, Kwon HS, Larsen J, Lee AH, Lee J, Medvedeva K, Munkombwe Z, Oh I, Park J, Park J, Putri DE, Rodgers J, Ryu S, Savkina M, Schreitmueller T, Semeniuk O, Seo M, Shin YI, Shin J, Srivastava S, Song H, Song S, Tavares Neto J, Wadhwa M, Yamaguchi T, Youn HD, Yun M. Wadhwa M, et al. Among authors: savkina m. Biologicals. 2020 May;65:50-59. doi: 10.1016/j.biologicals.2019.12.008. Epub 2020 Jan 17. Biologicals. 2020. PMID: 31959504
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