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PHARMACOKINETICS OF MULTIPLE DOSAGE ORAL PALIPERIDONE BIOEQUIVALENCE STUDIES

PRESENTED TO: AAPS PHARMSCI 360 by BioPharma Services
PRESENTED BY: M. NGOC LE, J. HE, J. OLDENHOF

PURPOSE

Paliperidone oral tablets and depot injections were approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for schizophrenia in adults and adolescents. Both agencies published bioequivalence (BE) product specific guidance for paliperidone. While two single dose studies with 6 mg tablets in normal healthy volunteers (NHV) are required by the FDA to demonstrate BE, the BE studies for the depot must be performed in patients.

In contrast, the EMA requires the BE studies to be done in healthy volunteers for both oral tablets3 and injection4 at the highest feasible strength. Various studies 5-7 were performed in NHV at different oral doses, but there was no study for paliperidone depot conducted in NHV. Furthermore, Health Canada has raised certain safety concerns about conducting BE studies of CNS drugs in NHV, including paliperidone

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