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| home > ebr > spring 2004 > bridging studies - what questions should be asked in phase i clinical research? |
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European BioPharmaceutical Review
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| Inter-ethnic, head-to-head, pharmacovariance or bridging: although they may sound very different, essentially these types of study have the same objective - to provide integrated clinical data towards a new ethnic region regulatory dossier, thus allowing the extrapolation of foreign clinical data for regulatory submission - to bridge the gap between data obtained in distinct ethnic regions. |
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