Determination of Plasma Concentration Reference Ranges for Risperidone and Paliperidone

Area of Science:

• Pharmacology
• Psychiatry
• Clinical Chemistry

Background:

• Schizophrenia management relies heavily on antipsychotic medications (APS).
• Suboptimal treatment outcomes are common due to inadequate response, poor adherence, or adverse events.
• Therapeutic drug monitoring of APS plasma concentrations can optimize patient care.

Purpose of the Study:

• To develop population pharmacokinetic (PK)-derived reference ranges for risperidone and paliperidone plasma concentrations.
• To provide a tool for interpreting individual plasma concentrations beyond traditional therapeutic ranges.
• To aid clinicians in optimizing antipsychotic therapy for schizophrenia patients.

Main Methods:

• Population pharmacokinetic modeling was employed to derive reference ranges.
• Models accounted for variations in administration route, dosage, and time post-administration.
• Graphical and numerical evaluations were used to assess agreement with external data.

Main Results:

• Novel reference ranges for risperidone and paliperidone plasma concentrations were successfully developed.
• The derived reference ranges demonstrated good agreement with external datasets.
• The findings support the clinical utility of these reference ranges for individual patient management.

Conclusions:

• Population PK-based reference ranges offer a valuable tool for interpreting risperidone and paliperidone plasma levels.
• These ranges can assist clinicians in making more informed treatment decisions for schizophrenia.
• The developed reference ranges are suitable for reliable clinical application.