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Page 1
The risks of risk aversion in drug regulation.
Eichler HG, Bloechl-Daum B, Brasseur D, Breckenridge A, Leufkens H, Raine J, Salmonson T, Schneider CK, Rasi G. Eichler HG, et al. Among authors: schneider ck. Nat Rev Drug Discov. 2013 Dec;12(12):907-16. doi: 10.1038/nrd4129. Epub 2013 Nov 15. Nat Rev Drug Discov. 2013. PMID: 24232377 Review.
Taking immunogenicity assessment of therapeutic proteins to the next level.
Büttel IC, Chamberlain P, Chowers Y, Ehmann F, Greinacher A, Jefferis R, Kramer D, Kropshofer H, Lloyd P, Lubiniecki A, Krause R, Mire-Sluis A, Platts-Mills T, Ragheb JA, Reipert BM, Schellekens H, Seitz R, Stas P, Subramanyam M, Thorpe R, Trouvin JH, Weise M, Windisch J, Schneider CK. Büttel IC, et al. Among authors: schneider ck. Biologicals. 2011 Mar;39(2):100-9. doi: 10.1016/j.biologicals.2011.01.006. Epub 2011 Feb 24. Biologicals. 2011. PMID: 21353596
Regulatory evaluation of Glybera in Europe - two committees, one mission.
Melchiorri D, Pani L, Gasparini P, Cossu G, Ancans J, Borg JJ, Drai C, Fiedor P, Flory E, Hudson I, Leufkens HG, Müller-Berghaus J, Narayanan G, Neugebauer B, Pokrotnieks J, Robert JL, Salmonson T, Schneider CK. Melchiorri D, et al. Among authors: schneider ck. Nat Rev Drug Discov. 2013 Sep;12(9):719. doi: 10.1038/nrd3835-c1. Epub 2013 Aug 19. Nat Rev Drug Discov. 2013. PMID: 23954897 No abstract available.
Setting the stage for biosimilar monoclonal antibodies.
Schneider CK, Vleminckx C, Gravanis I, Ehmann F, Trouvin JH, Weise M, Thirstrup S. Schneider CK, et al. Nat Biotechnol. 2012 Dec;30(12):1179-85. doi: 10.1038/nbt.2447. Nat Biotechnol. 2012. PMID: 23222783 No abstract available.
Biosimilars: what clinicians should know.
Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, Gravanis I, Heim HK, Heinonen E, Ho K, Moreau A, Narayanan G, Kruse NA, Reichmann G, Thorpe R, van Aerts L, Vleminckx C, Wadhwa M, Schneider CK. Weise M, et al. Among authors: schneider ck. Blood. 2012 Dec 20;120(26):5111-7. doi: 10.1182/blood-2012-04-425744. Epub 2012 Oct 23. Blood. 2012. PMID: 23093622 Free article. Review.
In support of the European Union biosimilar framework.
Schneider CK, Borg JJ, Ehmann F, Ekman N, Heinonen E, Ho K, Hoefnagel MH, van der Plas RM, Ruiz S, van der Stappen AJ, Thorpe R, Tiitso K, Tsiftsoglou AS, Vleminckx C, Waxenecker G, Welin M, Weise M, Trouvin JH; Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP); Biologicals Working Party (BWP) of the Committee for Medicinal Products for Human Use (CHMP). Schneider CK, et al. Nat Biotechnol. 2012 Aug;30(8):745-8; author reply 748-9. doi: 10.1038/nbt.2322. Nat Biotechnol. 2012. PMID: 22871707 No abstract available.
59 results