Streamlining Clinical Trials

Pharmacokinetic/pharmacodynamic (PK/PD) models represent the mathematical and statistical relationships between dose and dose regimen, plasma drug concentration, and drug effect.

PK/PD models provide the opportunity to explore permutations of future trial designs and alternative hypotheses about pharmacokinetics, drug effects, and population variability.

PK/PD 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.

PK/PD model simulations are particularly well-suited for quantifying the range of treatment outcomes in a given patient population. This provides confidence in selecting doses and regimens in trials ranging from First-in-Man to Phase III.

PK/PD models are also powerful tools for informing other key decisions, for example:

• Determining the number of study arms and sizes of study groups
• Selecting comparators, endpoints, and measurement intervals
• Managing risk due to population variability and drug effect uncertainty
• Determining patient inclusion/exclusion criteria
• Quantifying and improving the probability of trial success
• Supporting go/no-go decisions

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 or view an example model.