Using validated model informed precision dosing for dose adjustment: superior evidence needed for efficacy and safety.

INTRODUCTION

Modelinformed precision dosing (MIPD) allows determining the optimal dosage regimen and its correction based on the target plasma/serum concentrations of the drug. MIPD software must go through a validation and clinical study of its effectiveness and safety before being used in clinical practice.

AREAS COVERED

This narrative literature review provides insight into what is known to date about efficacy and safety trials of MIPD concept. Relevant publications were searched for in the PubMed database, without time or language constraints.

EXPERT OPINION

The application of MIPD in clinical practice logically and theoretically has great potential to improve the treatment of patients by leading to optimal exposure of target tissues to drugs, while achieving full effect and minimizing toxicity. Greater implementation of MIPD in clinical practice is hindered by the fact that the beneficial effects of MIPD on treatment outcomes and reduction of drug toxicity have been proven through clinical studies only for a small number of drugs. It is necessary to conduct well-designed clinical studies of the effects of MIPD, with sufficient statistical power, to prove the benefits of MIPD administration and to justify the costs of implementation in clinical practice.