Inleiding
Geneesmiddelen kunnen gunstige, maar ook schadelijke effecten bij patiënten teweegbrengen. Voordat een geneesmiddel op de markt wordt toegelaten, wordt het onder streng gecontroleerde omstandigheden bij de mens uitgetest. Nieuwe geneesmiddelen die onderzocht worden, worden investigational medicinal product s (IMP’s ) genoemd.
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EMA, Committee for Medicinal Products for Human Use (CHMP), 19 July 2007. Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products. http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002988.pdf.
EM(E)A, ICH topic E11, January 2001. Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002926.pdf.
Good clinical practice guidelines. http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html.
ICH guideline M3(R2), December 2009. ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals, step 5. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002720.pdf.
ICH Richtlijnen voor ontwikkeling van geneesmiddelen. http://www.ich.org/products/guidelines.
MedDRA Maintenance and Support Services Organization. http://www.meddramsso.com/.
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), July 2005. Guidance for Industry. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. http://www.fda.gov/downloads/Drugs/Guidances/UCM078932.pdf.
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), January 2006. Guidance for Industry, investigators and reviewers. Exploratory IND studies. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078933.pdf.
What is a serious adverse event? http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm.
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Van Bortel, L., Vanmolkot, F., Van Lancker, G. (2014). Exploratory clinical development. In: Out, H., van Meurs, P., van Olden, R. (eds) Handboek farmaceutische geneeskunde. Bohn Stafleu van Loghum, Houten. https://doi.org/10.1007/978-90-368-0265-9_2
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