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July 8, 2026British Journal of Clinical Pharmacology

Application of physiologically‐based pharmacokinetic modelling to guide oral ketamine prescription in analgesic doses

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Authors

PGPaulo Roberto Nunes de GóesMTMarilda Onghero TaffarelADAndréa Diniz

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Overview

Randomized trial explores optimal oral ketamine dosage for analgesia in diverse adult populations, indicating tailored prescribing may enhance safety.

Key Points

  • This study aims to evaluate dosing protocols for oral racemic ketamine using physiologically based pharmacokinetic models for diverse populations.
  • Constructed PBPK models of ketamine and norketamine using clinical data and Simcyp® Simulator.
  • Validated models through the comparison of predicted and observed plasma concentration profiles.
  • Conducted simulations of oral dosing regimens (0.3–1.25 mg/kg, every 2–12 h) in virtual populations (Caucasian, Japanese, and Chinese).
  • Validated models accurately predicted plasma exposure for ketamine and norketamine with MFE ranges of 0.5–2.0.
  • In simulations, ketamine exposure was about 60% higher and norketamine concentrations were 25% lower in Asian adults compared to Caucasians.
  • Oral doses of 0.75–1.0 mg/kg every 6–8 h maintained norketamine levels within therapeutic ranges, avoiding anaesthetic side effects.

Cite This Study

Góes et al. (2026) studied this question.

synapsesocial.com/papers/6a4de9e4d2ea289ef6283e18https://doi.org/10.1002/bcp.70662
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