Optimizing Dosing for the Safe and Effective Use of Drugs in Patients with Renal Impairment

Venue: Omni Shoreham Hotel

Location: Washington, District of Columbia, United States

Event Date/Time: Sep 19, 2011 End Date/Time: Sep 20, 2011
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Patients with renal impairment are at increased risk for developing drugrelated
adverse events. In these patients drug dosage needs to be closely monitored and adjusted to refl ect altered pharmacokinetics (PK) and pharmacodynamics (PD) parameters. This conference will provide a forum for the discussion of the following concepts:
• What to consider when designing, conducting, and analyzing dedicated renal impairment studies
• How to estimate renal function
• How to label a drug to provide clinically relevant information on the effects of reduced renal function on the drug’s PK/PD properties
• How to integrate and interpret data from a specific drug development program to assess the effects of renal impairment on drug safety
and efficacy
• How to determine the magnitude of dose adjustment required as renal function declines
• How to move from clinical trial data to real world practice when dosing special populations (i.e. morbidly obese)

• Breakout sessions for study design and analysis
• Expert panel discussions

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