The 2008 version of the Simcyp Paediatric Simulator provides valuable information relevant to first-time dosing decisions and the design of clinical studies in infants, neonates and children.
Simcyp Paediatric models pharmacokinetic behaviour over any age range using in vitro data routinely generated during drug discovery and development.
This allows 'what-if' questions to be explored in the safety of a computer.
The flexibility of the platform also allows predictions to be made from adult in vivo values by retrograde modelling.
The Simcyp simulations are carried out in virtual populations of children, rather than a single individual.
This produces 'real world' predictions and can identify the characteristics of patients at the extremes of exposure.
"Traditional dosing decisions have often been taken under the false assumption that young children are simply little adults," according to Trevor Johnson, senior pharmacist at Sheffield Children's Hospital and senior scientist at Simcyp.
"This model takes into account the many changes in pharmacokinetics which occur as a result of organ maturation and changes in body composition and drug elimination pathways".
Johnson commented: "Fewer than 50% of children's medicines have actually been tested in an appropriate age group.
"Simcyp Simulations allow a clinical study in children to become 'confirmatory' rather than 'exploratory', reducing unnecessary drug exposure.
"This is crucial now that EU regulations insist that paediatric data be included in all applications for new medicinal products".
Simcyp Paediatric 2008 is available to Simcyp Consortium members as a module to integrate with the Simcyp Population-based Adme Simulator.
