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Overview and Introduction - BEBAC • Consultancy Services for ...

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1/6 | <strong>Overview</strong> & <strong>Introduction</strong>Main TopicsEthics (GCP!)Dose levels / number of administered dosesNumber / volume of blood samplesDrug <strong>and</strong>/or adverse effectsClinical per<strong>for</strong>mance (GCP!)CRO selectionResponsibilities of sponsor / investigatorAudits / monitoringin<strong>for</strong>malife sciencesBioequivalence <strong>and</strong> Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 2010 7 • 10

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