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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

Bridging Studies - What Questions Should be Asked in Phase I Clinical Research?

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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By Dr Jörg Täubel, Managing Director of Richmond Pharmacology

Dr Jörg Täubel, MD MFPM, is the Managing Director of Richmond Pharmacology, a Phase I CRO conducting human clinical research for pharmaceutical companies. To date he has conducted more than 200 Phase I and early Phase IIa studies in patients and healthy volunteers, and has been co-investigator for at least 150. His experience ranges from simple bioequivalence to complex pharmacokinetic and pharmacodynamic studies, often administering compounds first in man, and his particular interest is gastroenterology and bridging studies. Dr TФubel is a leading expert in running bridging studies and is regularly invited to write articles and present on the issues surrounding these complex studies.

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Dr Jörg Täubel
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