Mechanistic PBPK modeling of special population groups – considerations and opportunities

Importance of PBPK Modeling in Special Populations

  • Unwarranted studies, due to the general nature of regulatory guidelines, may be avoided.
  • Alleviation of the ethical problems and recruitment issues associated with clinical studies in children or subjects with more severe impairment of organs.
  • Modeling helps to plan and optimize study design.
  • Model simulations help to predict likely outcome in the disease population.
  • Current built-in physiologies for special populations include: Pediatric, Liver Cirrhosis, Renal Impairment, Obesity, Pregnancy
  • The flexibility of GastroPlus, and access to all physiological parameters, allows the user to create custom physiologies representing many conditions with an understanding of the appropriate changes.
  • We’re pleased to help users create custom gut (.cat) and the whole body physiology (.pbk) files that incorporate physiological changes relevant for specific population