Hoekman J - Search Results

1

Estimation of manufacturing development costs of cell-based therapies: a feasibility study.

Ten Ham RMT, Nievaart JC, Hoekman J, Cooper RS, Frederix GWJ, Leufkens HGM, Klungel OH, Ovelgönne H, Hoefnagel MHN, Turner ML, Mountford JC. Ten Ham RMT, et al. Among authors: hoekman j. Cytotherapy. 2021 Aug;23(8):730-739. doi: 10.1016/j.jcyt.2020.12.014. Epub 2021 Feb 13. Cytotherapy. 2021. PMID: 33593688 Free article.

2

The use of surrogate endpoints in regulating medicines for cardio-renal disease: opinions of stakeholders.

Schievink B, Lambers Heerspink H, Leufkens H, De Zeeuw D, Hoekman J. Schievink B, et al. Among authors: hoekman j. PLoS One. 2014 Sep 30;9(9):e108722. doi: 10.1371/journal.pone.0108722. eCollection 2014. PLoS One. 2014. PMID: 25268242 Free PMC article.

3

Does conditional approval for new oncology drugs in Europe lead to differences in health technology assessment decisions?

Lipska I, Hoekman J, McAuslane N, Leufkens HG, Hövels AM. Lipska I, et al. Among authors: hoekman j. Clin Pharmacol Ther. 2015 Nov;98(5):489-91. doi: 10.1002/cpt.198. Epub 2015 Sep 8. Clin Pharmacol Ther. 2015. PMID: 26250656 Review.

4

Adverse Drug Reaction Reporting in Africa and a Comparison of Individual Case Safety Report Characteristics Between Africa and the Rest of the World: Analyses of Spontaneous Reports in VigiBase®.

Ampadu HH, Hoekman J, de Bruin ML, Pal SN, Olsson S, Sartori D, Leufkens HG, Dodoo AN. Ampadu HH, et al. Among authors: hoekman j. Drug Saf. 2016 Apr;39(4):335-45. doi: 10.1007/s40264-015-0387-4. Drug Saf. 2016. PMID: 26754924 Free PMC article.

5

Accelerating access to new medicines: Current status of facilitated regulatory pathways used by emerging regulatory authorities.

Liberti L, Breckenridge A, Hoekman J, Leufkens H, Lumpkin M, McAuslane N, Stolk P, Zhi K, Rägo L. Liberti L, et al. Among authors: hoekman j. J Public Health Policy. 2016 Aug;37(3):315-333. doi: 10.1057/jphp.2016.8. Epub 2016 Mar 10. J Public Health Policy. 2016. PMID: 26961261

6

Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.

Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, De Bruin ML. Hoekman J, et al. Br J Clin Pharmacol. 2016 Jul;82(1):213-26. doi: 10.1111/bcp.12940. Epub 2016 Apr 22. Br J Clin Pharmacol. 2016. PMID: 26992001 Free PMC article.

7

Factors related to drug approvals: predictors of outcome?

Liberti L, Breckenridge A, Hoekman J, McAuslane N, Stolk P, Leufkens H. Liberti L, et al. Among authors: hoekman j. Drug Discov Today. 2017 Jun;22(6):937-946. doi: 10.1016/j.drudis.2017.03.003. Epub 2017 Mar 10. Drug Discov Today. 2017. PMID: 28288783 Review.

8

FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines.

Liberti L, Bujar M, Breckenridge A, Hoekman J, McAuslane N, Stolk P, Leufkens H. Liberti L, et al. Among authors: hoekman j. Front Pharmacol. 2017 Apr 3;8:161. doi: 10.3389/fphar.2017.00161. eCollection 2017. Front Pharmacol. 2017. PMID: 28420989 Free PMC article.

9

Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation.

Coppens DGM, De Bruin ML, Leufkens HGM, Hoekman J. Coppens DGM, et al. Among authors: hoekman j. Clin Pharmacol Ther. 2018 Jan;103(1):120-127. doi: 10.1002/cpt.894. Epub 2017 Nov 6. Clin Pharmacol Ther. 2018. PMID: 28983911 Review.

10

EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.

de Wilde S, Coppens DGM, Hoekman J, de Bruin ML, Leufkens HGM, Guchelaar HJ, Meij P. de Wilde S, et al. Among authors: hoekman j. Drug Discov Today. 2018 Jul;23(7):1328-1333. doi: 10.1016/j.drudis.2018.03.008. Epub 2018 Mar 21. Drug Discov Today. 2018. PMID: 29574211 Free article. Review.

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