Rosa's Approach

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Understanding Mechanism of Action

Rosa’s custom-designed PhysioPD™ models explicitly represent mathematical relationships between relevant physiological, pathophysiological, and pharmacological processes.

PhysioPD models provide the opportunity to explore permutations of future study designs and alternative hypotheses about mechanisms of action.

PhysioPD Applications

Decision-focused in silico simulation can quickly and inexpensively predict trial outcomes or identify which in vivo experiments should be performed to reduce uncertainty. This knowledge supports the design of informative exploratory trials, and conclusive confirmatory trials.

PhysioPD model simulations are particularly well-suited for elucidating sub-clinical processes that influence clinical outcomes. This provides new insights into complex mechanisms of action that determine the direction of program and study strategies.

PhysioPD models are also powerful tools for informing other key decisions, for example:
  • Predicting human response from animal data reliably
  • Selecting comparators, biomarkers, and measurement times
  • Identifying differential drug effects in distinct patient types
  • Clarifying informative dose ranges for early studies
  • Prioritizing targets and compounds
  • Designing Proof-of-Mechanism trials

As a rule, Rosa carefully documents every model. In addition, clients often ask Rosa to document the models and simulations in a format suitable for use in regulatory discussions.

See our cases for actual applications.