Physiologically-based pharmacokinetic PBPK models using the Simcyp Simulator employing in vitro absorption, distribution, metabolism, and excretion (ADME) and physicochemical data, clinical pharmacokinetic (PK) data of quetiapine IR/XR in adults and clinical PK data of quetiapine IR in children were developed. These models predicted the effects of CYP3A4 inhibition and induction on the PK of quetiapine, the PK profile of quetiapine IR in children and adults, and the PK profile of quetiapine XR in adults. Most important, the PBPK model predicted that children and adolescents are likely to achieve a similar exposure following administration of either the XR formulation once daily or the IR formulation twice daily at similar total daily doses.

This was a high impact use of pediatric PBPK modelling given that a clinical study was avoided and approval was given for the pediatric labeling of quetiapine XR.

Early onset schizophrenia and bipolar disorder can occur in children as young as 12 years. As with many mental illnesses, adherence to drug regimen is a challenge, especially for teenagers.

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