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Clinical trials in cystic fibrosis
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health. (Allmänpediatrisk forskning/Nordvall)
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2007 (English)In: Journal of Cystic Fibrosis, ISSN 1569-1993, E-ISSN 1873-5010, Vol. 6, no 2, 85-99 p.Article in journal (Refereed) Published
Abstract [en]

In patients with cystic fibrosis (CF), clinical trials are of paramount importance. Here, the current status of drug development in CF isdiscussed and future directions highlighted. Methods for pre-clinical testing of drugs with potential activity in CF patients including relevantanimal models are described. Study design options for phase II and phase III studies involving CF patients are provided, including requiredpatient numbers, safety issues and surrogate end point parameters for drugs, tested for different disease manifestations. Finally, regulatoryissues for licensing new therapies for CF patients are discussed, including new directives of the European Union and the structure of aEuropean clinical trial network for clinical studies involving CF patients is proposed.

Place, publisher, year, edition, pages
2007. Vol. 6, no 2, 85-99 p.
Keyword [en]
Animal models, Drug development, Drug licensing, European clinical trial network for CF, Pre-clinical drug testing, Safety issues, Surrogate end points
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-13924DOI: 10.1016/j.jcf.2007.02.001ISI: 000245778900001PubMedID: 17350898OAI: oai:DiVA.org:uu-13924DiVA: diva2:41694
Available from: 2008-01-28 Created: 2008-01-28 Last updated: 2011-04-11Bibliographically approved

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Johannesson, Marie
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