Delivery & PK-PD
The peak determines the toxicity
A formulation that moves the absorption maximum by two hours can move the toxicity envelope by an order of magnitude. A long-acting depot with a sharper release curve can collapse a daily-dosing protocol into a monthly one. A device-paced infusion adjusting to a measurable signal can convert a population-level dose-finding study into a closed-loop one.
We treat formulation parameters and delivery set-points as continuous decision variables against the body model. The output is the specification that maximises the endpoint at acceptable toxicity, with sensitivity to each parameter quantified — so you know which knob is worth re-engineering and which is not.
Where this lands
- Pre-formulation: absorption-rate constants and bioavailability targets
- Long-acting depot: release-kinetics curve as a continuous design parameter
- Device-paced infusion: control law against a measurable physiological signal
- Combination products: timing offset between two active agents
Where this works less well
Drug delivery problems that are primarily mechanical, manufacturing, or material science. We model the body’s response to the delivery curve, not the device itself.