Schellekens H - Search Results

1

Contribution of animal studies to evaluate the similarity of biosimilars to reference products.

van Meer PJ, Ebbers HC, Kooijman M, Gispen-de Wied CC, Silva-Lima B, Moors EH, Schellekens H. van Meer PJ, et al. Among authors: schellekens h. Drug Discov Today. 2015 Apr;20(4):483-90. doi: 10.1016/j.drudis.2014.11.009. Epub 2014 Nov 20. Drug Discov Today. 2015. PMID: 25463036 Review.

2

The ability of animal studies to detect serious post marketing adverse events is limited.

van Meer PJ, Kooijman M, Gispen-de Wied CC, Moors EH, Schellekens H. van Meer PJ, et al. Among authors: schellekens h. Regul Toxicol Pharmacol. 2012 Dec;64(3):345-9. doi: 10.1016/j.yrtph.2012.09.002. Epub 2012 Sep 12. Regul Toxicol Pharmacol. 2012. PMID: 22982732

3

Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab.

Ebbers HC, van Meer PJ, Moors EH, Mantel-Teeuwisse AK, Leufkens HG, Schellekens H. Ebbers HC, et al. Among authors: schellekens h. Drug Discov Today. 2013 Sep;18(17-18):872-9. doi: 10.1016/j.drudis.2013.05.004. Epub 2013 May 18. Drug Discov Today. 2013. PMID: 23688584 Review.

4

Immunogenicity of mAbs in non-human primates during nonclinical safety assessment.

van Meer PJ, Kooijman M, Brinks V, Gispen-de Wied CC, Silva-Lima B, Moors EH, Schellekens H. van Meer PJ, et al. Among authors: schellekens h. MAbs. 2013 Sep-Oct;5(5):810-6. doi: 10.4161/mabs.25234. Epub 2013 Jun 6. MAbs. 2013. PMID: 23924803 Free PMC article.

5

Towards a sustainable system of drug development.

Moors EHM, Cohen AF, Schellekens H. Moors EHM, et al. Among authors: schellekens h. Drug Discov Today. 2014 Nov;19(11):1711-1720. doi: 10.1016/j.drudis.2014.03.004. Epub 2014 Mar 19. Drug Discov Today. 2014. PMID: 24657626 Review.

6

Are we ready to close the discussion on the interchangeability of biosimilars?

Ebbers HC, Schellekens H. Ebbers HC, et al. Among authors: schellekens h. Drug Discov Today. 2019 Oct;24(10):1963-1967. doi: 10.1016/j.drudis.2019.06.016. Epub 2019 Jun 26. Drug Discov Today. 2019. PMID: 31254488 Free article. Review.

7

Effective pharmaceutical regulation needs alignment with doctors.

Ebbers HC, Pieters T, Leufkens HG, Schellekens H. Ebbers HC, et al. Among authors: schellekens h. Drug Discov Today. 2012 Feb;17(3-4):100-3. doi: 10.1016/j.drudis.2011.09.018. Epub 2011 Oct 6. Drug Discov Today. 2012. PMID: 22001600

8

Conditional approval and approval under exceptional circumstances as regulatory instruments for stimulating responsible drug innovation in Europe.

Boon WP, Moors EH, Meijer A, Schellekens H. Boon WP, et al. Among authors: schellekens h. Clin Pharmacol Ther. 2010 Dec;88(6):848-53. doi: 10.1038/clpt.2010.207. Epub 2010 Oct 20. Clin Pharmacol Ther. 2010. PMID: 20962774

9

The risk-based approach to ATMP development - generally accepted by regulators but infrequently used by companies.

Kooijman M, van Meer PJ, Gispen-de Wied CC, Moors EH, Hekkert MP, Schellekens H. Kooijman M, et al. Among authors: schellekens h. Regul Toxicol Pharmacol. 2013 Nov;67(2):221-5. doi: 10.1016/j.yrtph.2013.07.014. Epub 2013 Aug 7. Regul Toxicol Pharmacol. 2013. PMID: 23933031

10

The value of non-human primates in the development of monoclonal antibodies.

van Meer PJ, Kooijman M, van der Laan JW, Moors EH, Schellekens H. van Meer PJ, et al. Among authors: schellekens h. Nat Biotechnol. 2013 Oct;31(10):882-3. doi: 10.1038/nbt.2709. Nat Biotechnol. 2013. PMID: 24104750 No abstract available.

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