An understanding of how a drug is absorbed into the human body (“pharmacokinetics” or PK) and how it achieves the target benefit (“pharmacodynamics” or PD) is a critical part of the drug development lifecycle.
Building models of these processes allows optimal doses to be selected for clinical trials while avoiding the risk of toxicity, taking patient variability into account.
Given the cost and timescale of drug development, in particular the expense of running clinical trials, such predictive capability is key for pharmaceutical drug development companies. Tessella’s expertise has enabled the development of a number of novel non-linear models, with associated solution methods, for systems which cannot be described using standard approaches. We have also developed easy-to-use software tools which allow the rapid solution of the equations for synthetic populations to assess variability in response. This has provided the capability to perform dose optimization and ‘what if’ analyses, which were not possible using the industry standard models and tools. Such a capability can also provide the basis for wider modelling of entire clinical trials, improving the probability of success and optimizing trial size to reduce unnecessary costs.