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