What is iDose®?
iDose is a patented, cloud-based decision support software service that enables physicians to individualize biologic dosing. Rather than relying on standard weight-based or population-average dosing, which lacks the therapeutic index information necessary to define a safe and effective dose for an individual patient, iDose uses Bayesian estimation and population pharmacokinetic (PK) modeling to integrate individual patient data, including drug concentrations, routine lab results, and demographics.
The result is a set of personalized dose and interval recommendations calculated to reach a physician-specified target trough concentration. That target trough concentration, which is not specified in FDA-approved labeling, is selected using clinical judgment.
The PK models underlying iDose are derived primarily from FDA-published summaries of well-controlled clinical trial data supporting licensure of each respective drug. That data is accessed through the Freedom of Information Act (FOIA) or, where FOIA is not available, from peer-reviewed scientific literature supported by the drug’s license holder.
The core functionality of iDose is described in FDA guidance.
Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications (2003):
“With only two or three samples per subject, the usual pharmacokinetic data analysis methods will not be able to make precise estimates of individual PK parameters. In these circumstances, a specialized technique, population PK analysis combined with Bayesian estimation method, can be used to approximate population and individual PK parameters, providing an exposure variable that is more readily correlated to response than the sparse plasma concentrations themselves. This approach is particularly useful when relatively complete PK information is desired, but it is difficult or unethical to sample repeatedly for example, in pediatric and geriatric populations (see the FDA guidance for industry on Population Pharmacokinetics).
Adequate and well-controlled clinical studies that investigate several fixed doses and/or measure systemic exposure levels, when analyzed using scientifically reasonable causal models, can predict exposure-response relationships for safety and/or efficacy and provide plausible hypotheses about the effects of alternative doses and dosage regimens not actually tested. This can suggest ways to optimize dosage regimens and to individualize treatment in specific patient subsets for which there are limited data.
A known exposure-response relationship can be used to (1) interpolate previous clinical results to new dosages and dosing regimens not well studied in clinical trials … Generally, these uses of exposure-response information are based on an understanding of the relationship between the response and concentration, and between dose and concentration.”
From Population Pharmacokinetics (2022):
Population PK models can predict individual patient exposures at specific time points regardless of the spread in sampling times (e.g., trough concentrations can be predicted for all subjects)…. Individual patient exposure metrics are generated based on Empirical Bayes Estimates (EBEs).
Who can use iDose®?
iDose is designed for healthcare professionals who prescribe and manage biologic therapy across inflammatory diseases, including gastroenterologists, rheumatologists, dermatologists, and pulmonologists, among others. It is offered as a software service for use by, or under the supervision of, a licensed clinician.
In practice, iDose serves three main practice settings:
Individual physicians and specialists can subscribe to iDose on a per-use basis, integrating precision dosing directly into their patient management workflow without institutional adoption.
Health systems and hospital networks, GI groups, and specialty practices benefit from iDose’s unlimited-physician facility model, which allows an entire practice to access individualized dosing calculations under a single annual facility fee with no cap on the number of patients or daily uses. iDose is also EHR-ready, supporting seamless integration into existing clinical workflows.
Firms with economic motivation in drug distribution (e.g., drug companies) are subject to a greater regulatory burden than healthcare professionals under FDA guidance. These firms should refer to Regulatory Considerations for Prescription Drug Use-Related Software (2023). Enterprise licensing terms can be compiled for consideration by these firms.
Why use iDose®?
Standard biologic dosing follows a one-size-fits-all model — fixed doses, fixed schedules, adjustments made only after something goes wrong. Up to 50% of patients lose response to biologic therapy within one year, driven by individual differences in drug clearance, anti-drug antibody (ADA) formation, and pharmacokinetics that standard dosing can’t account for.
iDose addresses this by combining individual patient data with Bayesian pharmacokinetic modeling to generate real-time, personalized dosing recommendations. Rather than reacting to treatment failure, iDose enables physicians to optimize dosing proactively, before response is lost.
How is iDose® classified by the FDA?
When used by or under the supervision of a healthcare professional, iDose is regulated under Section 520(o) of the Federal Food, Drug, and Cosmetic Act as clinical decision support software (CDSS). Under this classification, iDose is exempt from the definition of a medical device under Section 201(h) of the Act. Section 520(o) was established by the 21st Century Cures Act in December 2016 and does not require FDA clearance. CDSS is designed to inform clinical judgment, not direct therapy.
Firms with economic motivation related to drug distribution are subject to additional requirements under FDA guidance, including labeling updates prior to adopting CDSS. Baysient has no economic motivation in the distribution of drugs.
When iDose is used by healthcare payers (e.g., CMS, insurance companies), use must comply with the Federal Information Security Management Act (FISMA), enforced by the Office of Management and Budget.
How do I use iDose®?
Watch the walkthroughs below to see how iDose can be used across different dosing scenarios.
Scenario 1: Forecasting Initial Infliximab Dosing
See how iDose can be used before the first infliximab dose to forecast drug exposure in a patient with severe ulcerative colitis. This walkthrough demonstrates how patient-specific data are used to model the concentration-time profile, compare different dose and interval options, and estimate when the selected target trough may be reached. The example shows how clinicians can explore potential dosing approaches before treatment is administered.
Scenario 2: Forecasting the Transition to Subcutaneous Mirikizumab
See how iDose can be used to forecast the transition from IV induction to subcutaneous mirikizumab in a patient with moderate ulcerative colitis. The walkthrough models concentrations across multiple subcutaneous doses to show how the patient may progress toward the selected target trough over time. It also demonstrates how patient-specific factors, including albumin, can change the predicted clearance and dosing forecast.
Scenario 3: Forecasting the Transition to Subcutaneous Vedolizumab
See how iDose can be used to forecast the transition from IV induction to subcutaneous vedolizumab in a patient with moderate Crohn’s disease. The walkthrough models the concentration-time profile across several subcutaneous doses, illustrating how concentrations may take multiple doses to reach and stabilize around the selected target trough. It also reviews predicted clearance and probability curves to provide additional context for the dosing forecast.
What does an iDose® subscription include?
iDose is available on a subscription basis or as an enterprise solution. All subscriptions include:
- Unlimited patients
- Unlimited simulations per patient per day
- Training and support
- HIPAA-compliant data storage
- Unlimited patient report downloads (for manual EHR upload)
- EHR connection readiness (note: EHR implementation is not included)
How do I get started with iDose®?
Visit baysient.net/idose-product to learn more about the platform, and request a demo by filling out the form at the bottom of the page.
Implementation
iDose is typically implemented using a “hub” model, in which a designated data manager serves as the central administrator for the platform. This approach streamlines the flow of information to and from the application and ensures consistent, accurate data management across your practice or health system.
Early in the implementation process, identifying and training your data manager is the first priority. That person will be responsible for updating patient data, running dosing simulations, and communicating results to the clinical team.
Training and Onboarding
Once your subscription is established, your administrator will receive access to the iDose user manual and a series of training sessions. When training is complete, you are ready to begin using iDose in clinical practice.
