Straus SM - Search Results

1

Impact of safety-related regulatory action on clinical practice: a systematic review.

Piening S, Haaijer-Ruskamp FM, de Vries JT, van der Elst ME, de Graeff PA, Straus SM, Mol PG. Piening S, et al. Among authors: straus sm. Drug Saf. 2012 May 1;35(5):373-85. doi: 10.2165/11599100-000000000-00000. Drug Saf. 2012. PMID: 22480319 Review.

2

Non-cardiac QTc-prolonging drugs and the risk of sudden cardiac death.

Straus SM, Sturkenboom MC, Bleumink GS, Dieleman JP, van der Lei J, de Graeff PA, Kingma JH, Stricker BH. Straus SM, et al. Eur Heart J. 2005 Oct;26(19):2007-12. doi: 10.1093/eurheartj/ehi312. Epub 2005 May 11. Eur Heart J. 2005. PMID: 15888497

3

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. Among authors: straus sm. JAMA. 2008 Oct 22;300(16):1887-96. doi: 10.1001/jama.300.16.1887. JAMA. 2008. PMID: 18940975

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. Among authors: straus sm. Drug Saf. 2009;32(12):1175-87. doi: 10.2165/11318980-000000000-00000. Drug Saf. 2009. PMID: 19916584

5

A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009.

Mol PG, Straus SM, Piening S, de Vries JT, de Graeff PA, Haaijer-Ruskamp FM. Mol PG, et al. Among authors: straus sm. Drug Saf. 2010 Jun 1;33(6):463-74. doi: 10.2165/11532840-000000000-00000. Drug Saf. 2010. PMID: 20486729

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. Among authors: straus sm. Drug Saf. 2010 Oct 1;33(10):865-78. doi: 10.2165/11538330-000000000-00000. Drug Saf. 2010. PMID: 20812771

7

Additional safety risk to exceptionally approved drugs in Europe?

Arnardottir AH, Haaijer-Ruskamp FM, Straus SM, Eichler HG, de Graeff PA, Mol PG. Arnardottir AH, et al. Among authors: straus sm. Br J Clin Pharmacol. 2011 Sep;72(3):490-9. doi: 10.1111/j.1365-2125.2011.03995.x. Br J Clin Pharmacol. 2011. PMID: 21501215 Free PMC article.

8

Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.

Arnardottir AH, Haaijer-Ruskamp FM, Straus SM, de Graeff PA, Mol PG. Arnardottir AH, et al. Among authors: straus sm. Drug Saf. 2011 Nov 1;34(11):1101-14. doi: 10.2165/11592060-000000000-00000. Drug Saf. 2011. PMID: 21981437

9

Risk minimization activities of centrally authorized products in the EU: a descriptive study.

Zomerdijk IM, Sayed-Tabatabaei FA, Trifirò G, Blackburn SC, Sturkenboom MC, Straus SM. Zomerdijk IM, et al. Among authors: straus sm. Drug Saf. 2012 Apr 1;35(4):299-314. doi: 10.2165/11594560-000000000-00000. Drug Saf. 2012. PMID: 22339506

10

Vaccine-based subgroup analysis in VigiBase: effect on sensitivity in paediatric signal detection.

de Bie S, Verhamme KM, Straus SM, Stricker BH, Sturkenboom MC. de Bie S, et al. Among authors: straus sm. Drug Saf. 2012 Apr 1;35(4):335-46. doi: 10.2165/11598120-000000000-00000. Drug Saf. 2012. PMID: 22435344

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