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| home > ebr > spring 2004 > paediatric clinical trials - the challenges facing central laboratories |
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European BioPharmaceutical Review
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| With changes in legislation both in the US and Europe there is now more pressure on pharmaceutical companies to perform paediatric clinical studies. Most drugs prescribed for children have not been tested in children - only 20 to 30 per cent of drugs approved by the Food and Drug Administration are labelled for paediatric use. Doctors have routinely given drugs to children 'off label', which means the drug has not been studied in children in adequate, well-controlled clinical trials. The drug development industry will have to gear itself up to perform more paediatric studies in the coming years. The purpose of this article is to encourage discussion about services that may be required of central laboratories to support paediatric work. In the past, most central laboratories have not had to cater for many studies involving children. There are various central laboratory services that need to be added or modified to accommodate the demands of paediatric studies. Here are a few examples of the areas that should be reviewed. |
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Small Scale Biomanufacturing – clinical trials, cell & gene therapies
18 September 2008, Clifton Pavilion, Bristol Zoo Gardens, Bristol
This one day conference, sponsored by bioProcessUK and organised by BioApproaches South West, will cover key, important topics relating to small scale GMP biomanufacturing.
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