• The strategic objective of WP4 is to develop a comprehensive and full in silico pharmacokinetic (PK) model of hydrocortisone that can be used to inform rational formulation optimisation (in conjunction with WP3) and to predict drug absorption and disposition in the different paediatric age groups targeted.

  • Work Package 4

    WP4 will be led by SimCyp Ltd, with input from Diurnal Ltd. The pharmacokinetic modelling will be used to predict drug absorption and disposition in the different paediatric age groups targeted (neonates and infants), with the goal of optimising clinical trial design to minimise the number of patients required for the clinical study (WP5).

  • Work Package 4 

    • 4.1 Review and collate physiological and biochemical data
    • 4.2 Preclinical and clinical pharmacokinetic data and the development of compound files
    • 4.3 Development, validation and use of an in silico model
  • Work Package 4

    Deliverables
    Status
    Systematic Review
     
    Pharmacokinetic Data
     
    Compound Files
     
    Hydrocortisone in silico Models
     
    Verification of Models
     
    Integration from in silico Model
     
    Models input into TAIN clinical trial design