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Modern science for better quality control of medicinal products "Towards global harmonization of 3Rs in biologicals": The report of an EPAA workshop.
Schutte K, Szczepanska A, Halder M, Cussler K, Sauer UG, Stirling C, Uhlrich S, Wilk-Zasadna I, John D, Bopst M, Garbe J, Glansbeek HL, Levis R, Serreyn PJ, Smith D, Stickings P. Schutte K, et al. Among authors: smith d. Biologicals. 2017 Jul;48:55-65. doi: 10.1016/j.biologicals.2017.05.006. Epub 2017 Jun 7. Biologicals. 2017. PMID: 28596049 Free article.
Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities.
Akkermans A, Chapsal JM, Coccia EM, Depraetere H, Dierick JF, Duangkhae P, Goel S, Halder M, Hendriksen C, Levis R, Pinyosukhee K, Pullirsch D, Sanyal G, Shi L, Sitrin R, Smith D, Stickings P, Terao E, Uhlrich S, Viviani L, Webster J. Akkermans A, et al. Among authors: smith d. Biologicals. 2020 Nov;68:92-107. doi: 10.1016/j.biologicals.2020.07.010. Epub 2020 Oct 8. Biologicals. 2020. PMID: 33041187 Free PMC article.
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.
Bekeredjian-Ding I, Trouvin JH, Depraetere H, La C, Suvarnapunya AE, Bell A, Mann A, Meij P, Bethony JM, Schellhaas L, Nazziwa WB, Karikari-Boateng E, Prachumsri JS, Salmikangas P, Smith D, Stjärnkvist P, Van Molle W, Baay M, Neels P. Bekeredjian-Ding I, et al. Among authors: smith d. Biologicals. 2021 Nov;74:16-23. doi: 10.1016/j.biologicals.2021.09.002. Epub 2021 Oct 5. Biologicals. 2021. PMID: 34620540 Free article.
Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report.
Viviani L, Reid K, Gastineau T, Milne C, Smith D, Levis R, Lei D, van Ooij M, Gilbert PA, Vandeputte J, Xie J, Madhuri L, Shaid S, Kubiak V, Suri R, Mizukami T, Shirasaki Y, Li X, Zhou YY, Trapkova A, Goel S, Prakash J, Subagio AA, Suwarni E, Jung KJ, Sanyal G, Das P, Coppens E, Wright D, Peng Z, Northeved H, Jungbäck C, Kirpitchenok T, Del Pace L, Seo B, Poojary B, Ottoni A. Viviani L, et al. Among authors: smith d. Biologicals. 2022 Jul;78:17-26. doi: 10.1016/j.biologicals.2022.06.003. Epub 2022 Jul 12. Biologicals. 2022. PMID: 35840492 Free PMC article.
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities.
Sajjadi NC, Brady R, Jungbäck C, Mallet L, Milne C, Prior S, Pulle G, Rigsby P, Schofield T, Siggers R, Smith D, Stickings P, Uhlrich S, Van Molle W, Walker A, Wu T, Zhou T, Baca-Estrada M. Sajjadi NC, et al. Among authors: smith d. Biologicals. 2024 May;86:101756. doi: 10.1016/j.biologicals.2024.101756. Epub 2024 Mar 12. Biologicals. 2024. PMID: 38479213
A vision for patient-centric specifications for biologicals.
Krause P, Campa C, Chang A, Novick S, Rellahan B, Schofield T, Smith D. Krause P, et al. Among authors: smith d. Biologicals. 2024 Nov;88:101796. doi: 10.1016/j.biologicals.2024.101796. Epub 2024 Oct 14. Biologicals. 2024. PMID: 39405595 No abstract available.
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