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Activity Number:
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537
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Type:
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Invited
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Date/Time:
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Thursday, August 6, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303149 |
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Title:
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Leveraging Pharmacokinetic (PK) and Pharmacodynamic (PD) Knowledge in Early Clinical Drug Development
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Author(s):
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Ene I. Ette*+
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Companies:
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Anoixis Corporation
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Address:
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214 North Main Street, Suite 104, Natick, MA, 01760,
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Keywords:
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PK/PD ; Modeling ; Simulation ; Early ; Clinical ; Development
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Abstract:
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Knowledge gained from all available nonclinical and clinical data with the associated uncertainty is usually not considered in decision making in early clinical drug development. A model for early clinical development with PK/PD serving as the unifying basis is presented with an example. Nonclinical PK/PD data were modeled and integrated with toxicology and animal disease model data to design, simulate, and choose doses for a First-Time-In-Human (FTIH) study. Near real-time modeling and simulation aided the adaptation of the FTIH study. Finally, FTIH PK and PD modeling results were used to design a Phase II study. Linkage of predicted human exposures with in vitro and animal disease models PD resulted in the selection of a range of doses for the FTIH study yielding PD results spanning the desired range. Leveraging of PK/PD knowledge enabled the optimal design of a set of clinical trials.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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