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Development and Regulation of Connected Combined Products: Reflections From the Medtech & Pharma Platform Association.
Clin Ther. 2022 May;44(5):768-782. doi: 10.1016/j.clinthera.2022.03.009. Epub 2022 Apr 4.
Clin Ther. 2022.
PMID: 35393132
Free article.
Review.
Real-World Data in the Postapproval Setting as Applied by the EMA and the US FDA.
Mofid S, Bolislis WR, Kühler TC.
Mofid S, et al. Among authors: bolislis wr.
Clin Ther. 2022 Feb;44(2):306-322. doi: 10.1016/j.clinthera.2021.12.010. Epub 2022 Jan 21.
Clin Ther. 2022.
PMID: 35074209
Free article.
Review.
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From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety.
Bolislis WRR, Mortazavi C, Riccioni R, Schaeffer PE, Kühler TC.
Bolislis WRR, et al.
Ther Innov Regul Sci. 2020 Jul;54(4):831-838. doi: 10.1007/s43441-019-00018-0. Epub 2019 Dec 9.
Ther Innov Regul Sci. 2020.
PMID: 32557303
Free PMC article.
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Orphan Medicines for Pediatric Use: A Focus on the European Union.
Bolislis WR, Corriol-Rohou S, Hill-Venning C, Hoogland H, Joos A, King D, Kitcatt V, Le Visage G, Kühler TC.
Bolislis WR, et al.
Clin Ther. 2019 Dec;41(12):2630-2642. doi: 10.1016/j.clinthera.2019.10.006. Epub 2019 Nov 5.
Clin Ther. 2019.
PMID: 31704041
Free article.
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Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities.
Bolislis WR, de Lucia ML, Dolz F, Mo R, Nagaoka M, Rodriguez H, Woon ML, Yu W, Kühler TC.
Bolislis WR, et al.
Clin Ther. 2021 Jan;43(1):124-139. doi: 10.1016/j.clinthera.2020.11.015. Epub 2020 Nov 30.
Clin Ther. 2021.
PMID: 33353762
Free PMC article.
Review.
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The Utility of Remote Inspections During the COVID-19 Health Emergency and in the Postpandemic Setting.
Mofid S, Bolislis WR, Brading C, Hamilton N, Hardit C, Nagaoka M, Parain J, Zanta M, Kühler TC.
Mofid S, et al. Among authors: bolislis wr.
Clin Ther. 2021 Dec;43(12):2046-2063. doi: 10.1016/j.clinthera.2021.10.003. Epub 2021 Oct 13.
Clin Ther. 2021.
PMID: 34740466
Free PMC article.
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Use of Real-world Data for New Drug Applications and Line Extensions.
Bolislis WR, Fay M, Kühler TC.
Bolislis WR, et al.
Clin Ther. 2020 May;42(5):926-938. doi: 10.1016/j.clinthera.2020.03.006. Epub 2020 Apr 25.
Clin Ther. 2020.
PMID: 32340916
Free article.
Review.
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