Commentary on Fit-For-Purpose Models for Regulatory Applications.
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DOI: 10.1016/j.xphs.2018.09.009
Abstract: Model-based analyses have been applied to influence various drug development and regulatory decisions in the last 2 decades. Applied models range from empirical models to highly complex mechanistic models. "Fit-for-purpose" has been the principle to… read more here.
Keywords: models regulatory; fit purpose; model; regulatory applications ... See more keywords