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Potential use cases of IMPRES-M® single subject

IMPRES-M® is impulse-response modeling where the core representation of a PK curve is a smoothed version of observations. Let us discuss some potential use cases of this novel approach.

Use case #1

Imagine you get the data from a first-in-human trial with rich PK and PD sampling after single doses, and you are requested to indicate which doses to test with repeated dosing with a maximum impact on PD. The PD is directly related to plasma exposure. You could develop a PK model quickly, but it would still be very difficult to meet the team’s timeline. You could go with curve superposition, but that also takes quite a lot of time and tends to amplify noise in curves. Instead, you could pull the curves through IMPRES-M® and have PK extrapolations immediately, probably within the hour. Now, you have enough time to do PK-PD exploration and decide which dose would lead to the maximum PD impact after accumulation.

Use case #2

You are tasked with getting the potency of a new drug from an in vivo experiment, to compare it to a front runner drug. The typical approach would be to develop a PK model first to allow you to start PK-PD modeling, for example using a turnover model. That is all fine, but that may take you one or two days before you have it. Why take that time? With IMPRES-M® you have your PK model immediately which allows you to start PK-PD modeling right away and report the analysis ahead of time.

Use case #3

Data come in from a phase 2a trial and it appears that patients with a complex absorption pattern, e.g. double peaks, respond better. The team looks at you to find about the concentration-response and advise on the doses to pick for the upcoming dose range finder. You have been working hard on a PK model, but it is just impossible to get the double peaks right. Most models keep on pulling a straight line through one of them. Switching to IMPRES-M® allows you to track the double absorption peaks automatically and start exploring the PK-PD relationship in more detail.

More use cases?

There are many more possibilities to use IMPRES-M®. What would your way of working with it? Please let us know your favorite application at impresm@pd-value.com.

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For further introductions or to explore avenues of collaboration, please send an e-mail to jeroen@pd-value.com or see the contact page for other communication options.