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Page 1
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: van aerts l. 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.
Interchangeability of Biosimilars: A European Perspective.
Kurki P, van Aerts L, Wolff-Holz E, Giezen T, Skibeli V, Weise M. Kurki P, et al. Among authors: van aerts l. BioDrugs. 2017 Apr;31(2):83-91. doi: 10.1007/s40259-017-0210-0. BioDrugs. 2017. PMID: 28120313
[Immunogenicity of biosimilars].
van Aerts LA, Franken AA, Leufkens HG. van Aerts LA, et al. Ned Tijdschr Geneeskd. 2016;160:D888. Ned Tijdschr Geneeskd. 2016. PMID: 28000573 Review. Dutch.
The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.
Prior H, Andrews L, Cauvin A, Chien H, Clarke DO, Datta K, Dempster M, Dybdal N, Freebern W, de Haan L, Herzyk D, Hey A, Kissner T, Kronenberg S, Leach MW, Lee D, Reid K, Schutte K, Sewell F, Trouba K, Ulrich P, van Aerts L, van Meer P, Weir L. Prior H, et al. Among authors: van aerts l. Regul Toxicol Pharmacol. 2023 Feb;138:105339. doi: 10.1016/j.yrtph.2023.105339. Epub 2023 Jan 14. Regul Toxicol Pharmacol. 2023. PMID: 36649820 Free article. Review.
Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.
Chien HT, Prior H, Andrews L, van Aerts L, Cauvin A, Clarke DO, Datta K, Dempster M, Dybdal N, Freebern W, de Haan L, Herzyk D, Hey A, Kissner T, Kronenberg S, Leach MW, Lee D, Schutte K, Sewell F, Trouba K, Ulrich P, Weir L, van Meer P. Chien HT, et al. Among authors: van aerts l. Regul Toxicol Pharmacol. 2023 Feb;138:105329. doi: 10.1016/j.yrtph.2022.105329. Epub 2022 Dec 30. Regul Toxicol Pharmacol. 2023. PMID: 36592682 Free article.
Prediction of human drug-induced liver injury (DILI) in relation to oral doses and blood concentrations.
Albrecht W, Kappenberg F, Brecklinghaus T, Stoeber R, Marchan R, Zhang M, Ebbert K, Kirschner H, Grinberg M, Leist M, Moritz W, Cadenas C, Ghallab A, Reinders J, Vartak N, van Thriel C, Golka K, Tolosa L, Castell JV, Damm G, Seehofer D, Lampen A, Braeuning A, Buhrke T, Behr AC, Oberemm A, Gu X, Kittana N, van de Water B, Kreiling R, Fayyaz S, van Aerts L, Smedsrød B, Ellinger-Ziegelbauer H, Steger-Hartmann T, Gundert-Remy U, Zeigerer A, Ullrich A, Runge D, Lee SML, Schiergens TS, Kuepfer L, Aguayo-Orozco A, Sachinidis A, Edlund K, Gardner I, Rahnenführer J, Hengstler JG. Albrecht W, et al. Among authors: van aerts l. Arch Toxicol. 2019 Jun;93(6):1609-1637. doi: 10.1007/s00204-019-02492-9. Epub 2019 Jun 27. Arch Toxicol. 2019. PMID: 31250071
Finding synergies for 3Rs - Toxicokinetics and read-across: Report from an EPAA partners' Forum.
Laroche C, Aggarwal M, Bender H, Benndorf P, Birk B, Crozier J, Dal Negro G, De Gaetano F, Desaintes C, Gardner I, Hubesch B, Irizar A, John D, Kumar V, Lostia A, Manou I, Monshouwer M, Müller BP, Paini A, Reid K, Rowan T, Sachana M, Schutte K, Stirling C, Taalman R, van Aerts L, Weissenhorn R, Sauer UG. Laroche C, et al. Among authors: van aerts l. Regul Toxicol Pharmacol. 2018 Nov;99:5-21. doi: 10.1016/j.yrtph.2018.08.006. Epub 2018 Aug 23. Regul Toxicol Pharmacol. 2018. PMID: 30144470 Free article.
Preclinical and clinical safety studies on DNA vaccines.
Schalk JA, Mooi FR, Berbers GA, van Aerts LA, Ovelgönne H, Kimman TG. Schalk JA, et al. Among authors: van aerts la. Hum Vaccin. 2006 Mar-Apr;2(2):45-53. doi: 10.4161/hv.2.2.2620. Epub 2006 Mar 16. Hum Vaccin. 2006. PMID: 17012886 Review.
15 results