PK/PD Modelling
Are you in need of expert assistance during the drug development process? We’re here to help take your research to the next level. Our PK/PD modelling service offers a comprehensive solution to help optimize and streamline your research efforts. We will assist with our expertise in pharmacokinetics and pharmacodynamics, helping to achieve groundbreaking results.
How Does PK/PD Modelling Help?
PK/PD modelling is a mathematical approach to pharmacology, which integrates variables such as time, effect, etc. and potential covariates such as gender, age, etc. through mathematical modelling. PK/PD modelling is helpful at the drug screening stage, where it can accelerate the process of new drug development. PK (pharmacokinetic) modelling can clarify the effects potential drugs have on the body, while PD (pharmacodynamic) modelling investigates what effect the body has on a drug over the course of action.
PK/PD modelling is also useful at the preclinical and translational stage, where it can help understand how to design the most informative studies and how to set the starting dose of a First-In-Human (FIH) trial and how to escalate the dose into the dose range where efficacy or pharmacology is expected. As such, translational PK/PD modelling can save you time and money by providing a quantitative, data-driven argument to the regulators to help you design a phase I trial which starts at a dose level no lower than necessary yet still safe. It can help you assess if the trial is “on track” as the dose is being escalated by comparing the incoming clinical trial results against the translational PK/PD model based on your preclinical data, and helps you understand whether you are getting close to the dose range where efficacy and/or pharmacology is expected, so as to allow you to initiate the escalation cohorts (e.g. in the case of a standard 3+3 design).
Finally, it can help at the phase II trial design stage, when clinical data from a completed or ongoing phase I trial is available, with setting the Recommended Phase 2 Dose (RP2D), defining an appropriate dosing schedule, selecting populations of interest, etc.
ApPharMS can help you with all of the above and at all stages of the drug design process.
FAQs
Some of the specific questions that PKPD modelling can help you with:
- How do I forecast tumour growth inhibition (TGI) based on IC50 (in vitro potency)?
- Do my data confirm the (novel) therapeutic concept in animal studies to verify the proof of mechanism (PoM)?
- What is the target profile (e.g. potency, PK profile of a small molecule or biologic) I need to achieve to excel in direct and indirect competitions?
- How do I select the best combination partner for my drug?
- How do I select the time points (PK and PD), dose levels and dosing schedule for my preclinical studies to get the most crisp results at the least expense and study duration?
- How do I predict the human PK and PD of my small molecule or biologic?
- How do I test my (novel) therapeutic concept in the clinics?
- How do I structure/write a First-In-Human protocol and report for a submission to a regulatory agency?
- How do I select the starting dose for the First-In-Human trial (MABEL approach)?
- How can PK/PD modelling help find the pharmacologically active dose (PAD)?
- How do I select the efficacious dose of my compound (small molecule or biologics) for the First-In-Human study to verify proof of concept (PoC)?
- How do I select the timing of biopsy/PD biomarkers to verify proof of principle (PoP)?
- How do I determine the required PD (target engagement and / or disease modulation) biomarker responses in clinical PoP study to indicate early sign of efficacy?
- How do I interpret the phase I (First-In-Human) trial results to the end of setting a Recommended Phase II Dose (RP2D), selecting a subpopulation or a different dosing schedule for a potential expansion of the phase I trial, or designing a phase II trial?