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Area of Science:

  • Pharmacokinetics and Drug Delivery
  • Computational Modeling and Simulation
  • Pharmaceutical Sciences

Background:

  • Long-acting injectable (LAI) formulations require robust bioequivalence (BE) assessment.
  • Virtual bioequivalence (VBE) offers a potential alternative to clinical trials.
  • Paliperidone palmitate (PP) LAI suspensions necessitate accurate VBE methodologies.

Purpose of the Study:

  • To establish a workflow for VBE assessment of 3-month paliperidone palmitate (PP) LAI.
  • To develop and validate a physiologically-based pharmacokinetic (PBPK) model for PP LAI.
  • To determine the impact of formulation attributes, specifically particle size, on VBE trial design and sample size.

Main Methods:

  • Developed a mechanistic absorption and PBPK model implemented in the Simcyp® Simulator.
  • Calibrated the PBPK model against published population pharmacokinetic data.
  • Conducted extensive VBE simulations to estimate statistical power and required sample sizes for parallel trial designs.

Main Results:

  • The PBPK model accurately simulated PP drug concentration profiles.
  • Model predictions for key BE metrics (Cmax,ss, AUCtau,ss) showed <10% difference from validation data.
  • A 20% difference in mean drug particle radius between formulations approximately doubled the required sample size for BE demonstration.

Conclusions:

  • The developed PBPK model provides a reliable tool for VBE assessment of PP LAI.
  • Mean drug particle radius is a critical formulation attribute influencing VBE outcomes and sample size.
  • Rigorous model validation is essential for ensuring the reliability of VBE assessments.