Open AccessJournal Article10.3390/pharmaceutics15071859

Model-Informed Precision Dosing Software Tools for Dosage Regimen Individualization: A Scoping Review

- 01 Jul 2023

- Vol. 15, Iss: 7, pp 1859-1859

TL;DR: In this paper , a review and summary of the available evidence on MIPD software tools is presented to facilitate its identification, evaluation, and selection by users, and the main inclusion criteria were studies focused on developing software for use in clinical practice, research, or modelling.

Abstract: Background: Pharmacokinetic nomograms, equations, and software are considered the main tools available for Therapeutic Drug Monitoring (TDM). Model-informed precision dosing (MIPD) is an advanced discipline of TDM that allows dose individualization, and requires a software for knowledge integration and statistical calculations. Due to its precision and extensive applicability, the use of these software is widespread in clinical practice. However, the currently available evidence on these tools remains scarce. Objectives: To review and summarize the available evidence on MIPD software tools to facilitate its identification, evaluation, and selection by users. Methods: An electronic literature search was conducted in MEDLINE, EMBASE, OpenAIRE, and BASE before July 2022. The PRISMA-ScR was applied. The main inclusion criteria were studies focused on developing software for use in clinical practice, research, or modelling. Results: Twenty-eight software were classified as MIPD software. Ten are currently unavailable. The remaining 18 software were described in depth. It is noteworthy that all MIPD software used Bayesian statistical methods to estimate drug exposure and all provided a population model by default, except NONMEN. Conclusions: Pharmacokinetic software have become relevant tools for TDM. MIPD software have been compared, facilitating its selection for use in clinical practice. However, it would be interesting to standardize the quality and validate the software tools.

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Most frequently asked questions

1. What is model-informed precision dosing (MIPD)?

Model-informed precision dosing (MIPD) is an advanced discipline within therapeutic drug monitoring (TDM) that provides dose individualization based on TDM measurements and population models accounting for individual characteristics and intra/inter-patient variabilities. It integrates knowledge and mathematical optimization within specialized software, utilizing the Bayesian theorem for predictions of patient drug concentrations and dose recommendations. MIPD software has gained popularity due to its precision, advancements in population pharmacokinetic models, and applicability to a wide range of drugs. It is particularly valuable for dose individualization in vulnerable populations, such as elderly patients, those with renal or hepatic insufficiency, pregnant women, critically ill patients, and pediatric patients. However, the widespread adoption of MIPD software is limited by factors such as limited accessibility, lack of comprehensive information about features and clinical applicability, and the need for further development to enhance user-friendliness, data storage capacity, and report generation.

2. What criteria were used for software selection in MIPD clinical settings?

The criteria for software selection in MIPD clinical settings included suitability for the clinical setting, research or population pharmacokinetic modelling, and accuracy of data extraction. Insufficient information led to additional searches or contacting developers. Collected variables were classified into characteristics of articles and software. This ensured the software met the required characteristics and facilitated informed decision-making for researchers and clinicians.

Citations

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Correction: Del Valle-Moreno et al. Model-Informed Precision Dosing Software Tools for Dosage Regimen Individualization: A Scoping Review. Pharmaceutics 2023, 15, 1859

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TL;DR: The original publication contained an error and the corrected version is provided in this article.

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References

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PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation

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TL;DR: A PRISMA extension for scoping reviews was needed to provide reporting guidance for this specific type of knowledge synthesis and was developed according to published guidance by the EQUATOR (Enhancing the QUAlity and Transparency of health Research) Network for the development of reporting guidelines.

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Michael Neely, +4 more

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TL;DR: Building on over 3 decades of work, Pmetrics adopts a robust, reliable, and mature nonparametric approach to population modeling, which was better than the parametric method at discovering true pharmacokinetic subgroups and an outlier.

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•Journal Article•10.1016/J.ADDR.2014.05.016

Innovative approaches to optimizing the delivery of vancomycin in individual patients.

Manjunath P. Pai, +3 more

- 20 Nov 2014

- Advanced Drug Delivery Reviews

TL;DR: Two innovative approaches for calculating the vancomycin AUC in clinical practice based on one or two drug concentrations are reviewed, one of which involves the use of Bayesian computer software programs to estimate the "true" AUC value with minimal PK sampling and provide AUC-guided dosing recommendations at the bedside.

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•Journal Article•10.1007/S00228-020-03014-8

Therapeutic drug monitoring of oral targeted antineoplastic drugs.

Anna Mueller-Schoell, +10 more

- 01 Apr 2021

- European Journal of Clinical Pharmacolog...

TL;DR: TDM has been proven to be feasible for individualised dosing of abiraterone, everolimus, imatinib, pazopanib, sunitinib and tamoxifen in prospective studies and is a powerful tool to individualise drug dosing, ensure drug concentrations within the therapeutic window and increase treatment success rates.

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164

•Journal Article•10.1016/J.PHRS.2018.07.005

Clinical applications of population pharmacokinetic models of antibiotics: Challenges and perspectives

Femke de Velde, +4 more

- 01 Aug 2018

- Pharmacological Research

TL;DR: Three clinical applications of population PK models applied to antibiotics are highlighted, including dosing evaluation of old antibiotics, setting clinical breakpoints and dosing individualization using therapeutic drug monitoring (TDM).

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Model-Informed Precision Dosing Software Tools for Dosage Regimen Individualization: A Scoping Review

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AI Agents for this Paper

Most frequently asked questions

1. What is model-informed precision dosing (MIPD)?

2. What criteria were used for software selection in MIPD clinical settings?

Citations

Protocol to build a drug-testing pipeline using large populations of Drosophila melanogaster

Recommended approaches for integration of population pharmacokinetic modelling with precision dosing in clinical practice

IDoser: Improving individualized dosing policies with clinical practice and machine learning

Drosophila melanogaster experimental model to test new antimicrobials: a methodological approach

Correction: Del Valle-Moreno et al. Model-Informed Precision Dosing Software Tools for Dosage Regimen Individualization: A Scoping Review. Pharmaceutics 2023, 15, 1859

References

PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation

Accurate detection of outliers and subpopulations with Pmetrics, a nonparametric and parametric pharmacometric modeling and simulation package for R

Innovative approaches to optimizing the delivery of vancomycin in individual patients.

Therapeutic drug monitoring of oral targeted antineoplastic drugs.

Clinical applications of population pharmacokinetic models of antibiotics: Challenges and perspectives

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