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2 7 2 Summary Of Clinical Pharmacology
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2.7.3 summary of clinical efficacy
www.pmda.go.jpCONFIDENTIAL CM2003/00031/00 2.7.3 Summary of Clinical Efficacy - 7 - 1.1. Clinical Pharmacology and Biopharmaceutics Studies 1.1.1. CNA10905 Œ …
2.7.2 summary of clinical pharmacology Studies
www.pmda.go.jpCONFIDENTIAL RM2003/00379/00 2.7.2 Summary of Clinical Pharmacology 7 Linear pharmacokinetics are observed for ABC from single doses of 600 to 1200mg and at steady-state following repeat doses of 300mg twice a day (600mg daily) up to 600mg
REVISION OF M4E G E FORMAT AND S B -R I EFFICACY …
www.ich.orgThe Common Technical Document – Efficacy 1 MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES 2.5: CLINICAL OVERVIEW Preamble The Clinical Overview is intended to provide a critical analysis of the clinical data in the