Sponsored by Certara
The hepatic system plays a critical role in the elimination of many drugs. For the safe use of newly developing drugs, it is essential to understand any potential impact on drug exposure when this elimination system is impaired.
In this webinar, we will discuss:
• Criteria for determining if and when a hepatic impairment (HI) study is required, and situations where this is not relevant
• Considerations in the timing for an evaluation of the impact of HI
• Clinical study designs and other approaches for obtaining relevant HI data to address safe use of the drug
• Alternative approaches to HI studies such as population pharmacokinetics (PopPK) and physiologically based pharmacokinetic (PBPK) models to reduce or eliminate the need for dedicated clinical HI studies.
Specifically, we'll highlight case studies where PBPK modeling results were accepted in lieu of dedicated HI studies.
This webinar is intended for clinical pharmacologists, pharmacometricians, DMPK scientists, and regulatory scientists involved in planning HI studies and interested in applying model-informed drug development (MIDD) approaches to reduce uncertainty and accelerate decision-making.
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