Evidence map›Paper›PMID 40385249›Full record

ArticleCureus2025

Introducing Digital Pharmacometrics: A Pharmacokinetics (PK)/Pharmacodynamics (PD) Framework for Prescription Digital Therapeutics.

Shaheen E Lakhan

Abstract readEditorial
In one paragraph

Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Calcium sulfide nanoparticles as sustained HFrontiers in immunology · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author.

Shaheen E LakhanMedical Office, Click Therapeutics, Inc., New York, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Prescription digital therapeutics (PDTs) are FDA-authorized, clinically validated software applications that deliver behavioral and cognitive interventions through digital platforms. While these therapeutics are prescribed and regulated like drugs, they lack an established pharmacologic framework to define how digital content is delivered, processed, and translated into clinical benefit. In this editorial, we draw on rich experience in drug and PDT development to introduce the emerging discipline of digital pharmacometrics: the application of pharmacokinetics (PK) and pharmacodynamics (PD) principles to software-based medicine. We redefine classical concepts such as dose, exposure, and the absorption, distribution, metabolism, and excretion (ADME) framework for the context of digital therapeutics and identify Digital Working Alliance (DWA) formation as a critical modulator of therapeutic bioavailability. We also characterize digital PD through the development of dose-exposure-response curves that capture behavioral, biometric, and clinical outcomes, enabling closed-loop, adaptive therapeutic systems. This digital PK/PD model supports better trial design, labeling clarity, regulatory oversight, clinical guidance, and reimbursement models. By formally codifying how PDTs interact with patients and produce effects, digital pharmacometrics provides the scientific foundation necessary to scale precision software medicine.

Indexed as

adme frameworkbehavioral interventionsclosed-loop therapeuticsdigital dosedigital exposuredigital pharmacodynamicsdigital pharmacokineticsdigital working allianceprescription digital therapeuticssoftware-based medicine

Identifiers

PMID40385249
PMCPMC12083506

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.