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Regulatory workshop on challenge strain development and GMP manufacture - A stakeholder meeting report.
Corti N, Chiu C, Cox RJ, Demont C, Devaster JM, Engelhardt OG, Gorringe A, Hassan K, Hoefnagel M, Kamerling I, Krut O, Lane C, Liebers R, Luke C, Van Molle W, Morel S, Neels P, Roestenberg M, Rubbrecht M, Klaas Smits W, Stoughton D, Talaat K, Vehreschild MJGT, Wildfire A, Meln I, Olesen OF. Corti N, et al. Among authors: neels p. Biologicals. 2024 Feb;85:101746. doi: 10.1016/j.biologicals.2024.101746. Epub 2024 Feb 3. Biologicals. 2024. PMID: 38309984 Free article.
Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023.
Cavaleri M, Kaslow D, Boateng E, Chen WH, Chiu C, Choy RKM, Correa-Oliveira R, Durbin A, Egesa M, Gibani M, Kapulu M, Katindi M, Olotu A, Pongsuwan P, Simuyandi M, Speder B, Talaat KR, Weller C, Wills B, Baay M, Balasingam S, Olesen OF, Neels P. Cavaleri M, et al. Among authors: neels p. Biologicals. 2024 Feb;85:101745. doi: 10.1016/j.biologicals.2024.101745. Epub 2024 Feb 10. Biologicals. 2024. PMID: 38341355 Free 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: neels p. Biologicals. 2021 Nov;74:16-23. doi: 10.1016/j.biologicals.2021.09.002. Epub 2021 Oct 5. Biologicals. 2021. PMID: 34620540 Free article.
Fourth Controlled Human Infection Model (CHIM) meeting - CHIMs in endemic countries, May 22-23, 2023.
Kapulu M, Manda-Taylor L, Balasingam S, Means G, Ayiro Malungu M, Bejon P, Chi PC, Chiu C, Church EC, Correa-Oliveira R, Day N, Durbin A, Egesa M, Emerson C, Jambo K, Mathur R, Metzger W, Mumba N, Nazziwa W, Olotu A, Rodgers J, Sinyiza F, Talaat K, Kamerling I, Weller C, Baay M, Neels P. Kapulu M, et al. Among authors: neels p. Biologicals. 2024 Feb;85:101747. doi: 10.1016/j.biologicals.2024.101747. Epub 2024 Feb 13. Biologicals. 2024. PMID: 38350825 Free article.
49 results