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EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 20:12:20
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 Subject :EMEA Guidelines on Cystic Fibrosis Drug Development.. 2010-01-05 17:14:16 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
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Dear Friends,

The European Medicines Agency (EMEA) first guideline on developing products to treat cystic fibrosis advises drug makers to use forced expiratory volume (FEV) as the primary lung-function endpoint when designing clinical trials for the drugs. A clinically relevant change in FEV should be defined and justified by drug makers, as should the frequency of FEV measurements, according to the final guideline posted on the EMEA’s website last month.

Click here for this guideline

Kind regards,

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