iDose GEN7.0 introduces three powerful predictive decision-support tools that transform treatment monitoring from reactive to proactive: the probability of anti-drug-antibody occurrence at the present time, the probability of C-reactive protein (CRP) normalization at the present time, and the probability of mucosal healing at the present time. These capabilities enable physicians across relevant specialties to identify patients who may benefit from dose adjustments and more frequent clinical observation before treatment failure, thereby optimizing therapeutic outcomes and minimizing treatment failures.(i)
The platform also delivers significant workflow improvements with enhanced numerical entry capabilities and full EHR/EMR readiness, making it easier for healthcare professionals to integrate precision dosing into daily practice. iDose GEN7.0 maintains its foundation in combining smart technology with pharmacokinetic science to personalize biologic dosing decisions.
Physicians can learn more at baysient.net/idose-product/ and request a demo by visiting baysient.net/demo/.
Regulatory Information
- iDose is regulated by the FDA under section 520 (o) of the Federal Food, Drug, and Cosmetic Act as decision support software.
- iDose is offered as a software service for use by, or under the supervision of, health care professionals who have no "economic motivation related to [drug] product distribution." (ii)
- For firms, having economic motivation related to drug product distribution, enterprise licensing is available. FDA guidance has been published describing the regulatory requirements applicable to firms with economic motivation for using iDose (iii).
(i) Mould DR, Kutschera M, Primas C, Reinisch S, Novacek G, Lichtenberger C, Dervieux T, Bae Y, Lee SH, Lee JH, Reinisch W. Determination of correlation of clearance with clinical outcomes for inflammatory bowel disease. World J Gastroenterol 2025; In press
(ii) See: FDA legal Memorandum of January 2017, Public Health Interests and First Amendment Considerations Related to Manufacturers Communications Regarding Unapproved Uses of Approved and Cleared Medical Products.
(iii) See: FDA guidance Regulatory Considerations for Prescription Drug Use-Related Software, September 2023, Labeling.
About Baysient
Baysient develops SaaS, cloud-based software that provides medical providers with a full line of individual dosage-determination products. Baysient's software uses individual patient routine lab results and demographic information to allow physicians to individualize dosing to a specific target trough level. Learn more at baysient.net.
Media Contact:
Tracey Thomas
Media Relations, Baysient
[email protected]
(800) 340-5377
SOURCE Baysient
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