Multiple Dose Pharmacokinetics of Tapentadol Oral Solution for the Treatment of Moderate to Severe Acute Pain in Children Aged 2 to <7 Years.

Renata JończykChristoph Beuter Beata Bulawa Stefan Buller Christoph Eibl Christian EllingMichael GautroisJens RengelshausenCarsten SchmidtGuido ThömmesFeras Khalil

Published in: Journal of pain research (2022)

The findings confirm the linear and predictable PK profile of tapentadol hydrochloride. The good agreement between the observed data and the model predictions shows the value of modelling and simulations in the planning and analysis of pediatric clinical trials and the ability to utilize the established PK models to predict multiple dose exposure.

Keyphrases

clinical trial
chronic pain
pain management
electronic health record
neuropathic pain
high intensity
big data
molecular dynamics
replacement therapy
monte carlo
open label
smoking cessation