Giezen TJ - Search Results

1

Traceability of biologicals: present challenges in pharmacovigilance.

Vermeer NS, Spierings I, Mantel-Teeuwisse AK, Straus SM, Giezen TJ, Leufkens HG, Egberts TC, De Bruin ML. Vermeer NS, et al. Among authors: giezen tj. Expert Opin Drug Saf. 2015 Jan;14(1):63-72. doi: 10.1517/14740338.2015.972362. Epub 2014 Nov 5. Expert Opin Drug Saf. 2015. PMID: 25369769 Review.

2

Safety-related regulatory actions for biologicals approved in the United States and the European Union.

Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, Egberts AC. Giezen TJ, et al. JAMA. 2008 Oct 22;300(16):1887-96. doi: 10.1001/jama.300.16.1887. JAMA. 2008. PMID: 18940975

3

Pharmacovigilance of biopharmaceuticals: challenges remain.

Giezen TJ, Mantel-Teeuwisse AK, Leufkens HG. Giezen TJ, et al. Drug Saf. 2009;32(10):811-7. doi: 10.2165/11316550-000000000-00000. Drug Saf. 2009. PMID: 19722725 Review.

4

Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval.

Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Egberts TC, Blackburn S, Persson I, Leufkens HG. Giezen TJ, et al. Drug Saf. 2009;32(12):1175-87. doi: 10.2165/11318980-000000000-00000. Drug Saf. 2009. PMID: 19916584

5

Safety-related regulatory actions for orphan drugs in the US and EU: a cohort study.

Heemstra HE, Giezen TJ, Mantel-Teeuwisse AK, de Vrueh RL, Leufkens HG. Heemstra HE, et al. Among authors: giezen tj. Drug Saf. 2010 Feb 1;33(2):127-37. doi: 10.2165/11319870-000000000-00000. Drug Saf. 2010. PMID: 20082539

6

Mapping the safety profile of biologicals: a disproportionality analysis using the WHO adverse drug reaction database, VigiBase.

Giezen TJ, Mantel-Teeuwisse AK, Meyboom RH, Straus SM, Leufkens HG, Egberts TC. Giezen TJ, et al. Drug Saf. 2010 Oct 1;33(10):865-78. doi: 10.2165/11538330-000000000-00000. Drug Saf. 2010. PMID: 20812771

7

Rituximab-induced thrombocytopenia: a cohort study.

Giezen TJ, Mantel-Teeuwisse AK, ten Berg MJ, Straus SM, Leufkens HG, van Solinge WW, Egberts TC. Giezen TJ, et al. Eur J Haematol. 2012 Sep;89(3):256-66. doi: 10.1111/j.1600-0609.2012.01808.x. Epub 2012 Jul 5. Eur J Haematol. 2012. PMID: 22639923

8

Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction.

Ingrasciotta Y, Cutroneo PM, Marcianò I, Giezen T, Atzeni F, Trifirò G. Ingrasciotta Y, et al. Drug Saf. 2018 Nov;41(11):1013-1022. doi: 10.1007/s40264-018-0684-9. Drug Saf. 2018. PMID: 29796832 Review.

9

Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice.

Vermeer NS, Giezen TJ, Zastavnik S, Wolff-Holz E, Hidalgo-Simon A. Vermeer NS, et al. Among authors: giezen tj. Clin Pharmacol Ther. 2019 Apr;105(4):962-969. doi: 10.1002/cpt.1310. Epub 2019 Jan 11. Clin Pharmacol Ther. 2019. PMID: 30460997 Free PMC article.

10

Post-marketing dosing changes in the label of biologicals.

Minnema LA, Giezen TJ, Gardarsdottir H, Egberts TCG, Leufkens HGM, Mantel-Teeuwisse AK. Minnema LA, et al. Among authors: giezen tj. Br J Clin Pharmacol. 2019 Apr;85(4):715-721. doi: 10.1111/bcp.13843. Epub 2019 Feb 16. Br J Clin Pharmacol. 2019. PMID: 30593087 Free PMC article.

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