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Fda cardiovascular - PowerPoint PPT Presentation

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NDA 21-188. Omapatrilat in the Treatment of Hypertension Efficacy and Safety. Elliott Levy, M.D. Vice President, Clinical Design and Evaluation Pharmaceutical Research Institute. 7asdf. FDA Cardiovascular and Renal Drugs Advisory Committee Meeting July 19, 2002. Efficacy.

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The Science of Sex Differences in the Pharmacokinetics and Pharmacodynamics of Drugs - Case studies

Day 1. Day 23 (Steady State). Mean Change from Baseline QTc (msec). Mean Plasma Dofetilide Concentration (ng/mL). ? QTc (95% CI) =. Probability of NSR (95% CI) =. Probability of Remaining in NSR at 6 months (%) . QTc Change from Baseline at Steady State (msec). Dofetilide 125 mcg BID.

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Fda cardiovascular - PowerPoint PPT Presentation

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The Science of Sex Differences in the Pharmacokinetics and Pharmacodynamics of Drugs - Case studies