Although PBPK models are well-established tools for chemical risk assessment, their use in the drug discovery and development process has only recently been gaining acceptance. This presentation will illustrate advantages and limitations of PBPK modeling when applied in the pharmaceutical industry setting. Case studies will be presented in which PBPK models applied to therapeutic agents provided distinct advantages over conventional data-based PK modeling techniques. The availability and utility of in vitro, in vivo, and in silico tools and data for use in model parameterization and calibration will also be discussed.
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