PROJECT SUMMARY (See instructions):
To optimize drug dosing, clinicians may order laboratory testing of drug levels in patient blood samples, but
the clinical benefit of such testing is limited because testing is slow and infrequent. While field-use
measurement systems are a partial solution, a major problem is that a person's drug pharmacokinetics
(PK) can vary over time and from person to person. Through innovative use of new tools from Al and data
science, we propose to develop a personalized therapeutic drug monitoring (pTDM) system incorporating
(1) frequent noninvasive field measurements of drug levels and (2) a platform that delivers in real-time a
profile of the circulating drug levels and patient-reported clinical information. We will assess the system's
accuracy in the context of measuring salivary levels of anti-seizure medications for people with epilepsy. In
our four research aims, we will develop a personalized drug titration PK model; electrochemistry assays for
two anti-seizure drugs in saliva; electronic and electrochemical components and computational tools
needed for a field-use platform; and an integrated and validated field-use measurement platform. In our
two broader impacts aims, we will train students in transdisciplinary science and engage with caregivers
and patients to obtain feedback and ensure equitable benefits from pTDM.
Successful completion of our project's research aims will address critical knowledge gaps in how to (i)
account for varying pharmacokinetics in saliva-based personalized therapeutic drug monitoring; (ii)
address the challenges of electrochemical drug measurement in saliva given sample-to-sample variation in
background matrix; and (iii) address the challenges of integrated field-use pTDM system development with
low-power microelectronics. Further, the integrated system that we develop will demonstrate the benefits
of using machine-learning to overcome the challenges of variable PK and saliva background matrix in the
context of personalized therapeutic drug monitoring for chronic conditions and would be transformative for
the field. As such, our project is in excellent alignment with the NIBIB's mission to transform, through
garnering knowledge and technology development, disease treatment.
