Moors E - Search Results

1

Clinical comparability and European biosimilar regulations.

Schellekens H, Moors E. Schellekens H, et al. Among authors: moors e. Nat Biotechnol. 2010 Jan;28(1):28-31. doi: 10.1038/nbt0110-28. Nat Biotechnol. 2010. PMID: 20062035 No abstract available.

2

Exploring emerging technologies using metaphors--a study of orphan drugs and pharmacogenomics.

Boon W, Moors E. Boon W, et al. Among authors: moors e. Soc Sci Med. 2008 May;66(9):1915-27. doi: 10.1016/j.socscimed.2008.01.012. Epub 2008 Mar 4. Soc Sci Med. 2008. PMID: 18308439

3

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: moors eh. 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

4

A cohort study exploring determinants of safety-related regulatory actions for biopharmaceuticals.

Ebbers HC, Mantel-Teeuwisse AK, Moors EH, Sayed Tabatabaei FA, Schellekens H, Leufkens HG. Ebbers HC, et al. Drug Saf. 2012 May 1;35(5):417-27. doi: 10.2165/11597850-000000000-00000. Drug Saf. 2012. PMID: 22506566

5

Thirty years of preclinical safety evaluation of biopharmaceuticals: Did scientific progress lead to appropriate regulatory guidance?

Kooijman M, van Meer PJ, Moors EH, Schellekens H. Kooijman M, et al. Expert Opin Drug Saf. 2012 Sep;11(5):797-801. doi: 10.1517/14740338.2012.712110. Epub 2012 Aug 6. Expert Opin Drug Saf. 2012. PMID: 22861668 Review.

6

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. 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

7

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. MAbs. 2013 Sep-Oct;5(5):810-6. doi: 10.4161/mabs.25234. Epub 2013 Jun 6. MAbs. 2013. PMID: 23924803 Free PMC article.

8

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: moors eh. 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

9

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: moors eh. Nat Biotechnol. 2013 Oct;31(10):882-3. doi: 10.1038/nbt.2709. Nat Biotechnol. 2013. PMID: 24104750 No abstract available.

10

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. 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.

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