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

Area of Science:

• Pharmacology
• Clinical Pharmacy
• Computational Biology

Background:

• Therapeutic Drug Monitoring (TDM) relies on pharmacokinetic nomograms, equations, and software.
• Model-Informed Precision Dosing (MIPD) software enables individualized dosing through knowledge integration and statistical analysis.
• Despite widespread clinical use, evidence on MIPD software remains limited.

Purpose of the Study:

• To systematically review and synthesize existing evidence on MIPD software tools.
• To aid users in identifying, evaluating, and selecting appropriate MIPD software.
• To provide a comprehensive overview of currently available MIPD software.

Main Methods:

• An extensive electronic literature search was performed across major databases (MEDLINE, EMBASE, OpenAIRE, BASE) up to July 2022.
• The PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines were followed.
• Inclusion criteria focused on studies detailing software development for clinical practice, research, or modeling.

Main Results:

• Twenty-eight software tools were identified as MIPD software; 10 are currently unavailable.
• Detailed descriptions were provided for the remaining 18 accessible MIPD software.
• All reviewed MIPD software utilized Bayesian statistical methods for drug exposure estimation, with most offering a default population model (exception: NONMEN).

Conclusions:

• Pharmacokinetic software, particularly MIPD tools, are increasingly vital for effective TDM.
• Comparative analyses of MIPD software can guide clinical selection.
• Standardization of quality and validation of MIPD software are crucial for future development and clinical adoption.