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Monte Carlo simulations are commonplace in quantitative risk assessments (QRAs). Designed to propagate the variability and uncertainty associated with each individual exposure input parameter in a quantitative risk assessment, Monte Carlo methods statistically combine the individual parameter distributions to yield a single, overall distribution. Critical(More)
In the process of designing a clinical trial, the accuracy and precision of an endpoint is of critical importance in being able to determine valid results. In the creation and subsequent testing of the validity of an endpoint, it is desirable to show that on repeated measurements the endpoint can be measured precisely, and that it is reproducible with not(More)
We can apply both fixed and random effects models to multi-regional clinical trial (MRCT) design and data analysis. Thoroughly, understanding the features of these models in an MRCT setting will help assessing their applicability to an MRCT. In this paper, we discuss the interpretations of trial results from these models. We also evaluate the impact of the(More)
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