Product category:
Chemical modelling software
News Release from: Simcyp | Subject: Simcyp Paediatric Simulator
Edited by the Laboratorytalk Editorial
Team on 16 April 2008
Updated evaluation of medicines in
children
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
This article was originally published on Laboratorytalk on 14 Apr 2008 at 8.00am (UK)
Related stories
New version of Simcyp Adme simulator
Simcyp has released Simcyp Population-based ADME Simulator v8.0, a platform for the modelling and simulation of drug absorption, distribution, metabolism and elimination (Adme) in virtual populations
Winlims rental pays for itself
Cost savings achieved by the introduction of Winlims to a typical laboratory easily exceed the monthly payments required under the new Winlims Rental scheme
Integrated analytical QC at heart of Lims
"The quality control systems on other Lims systems are passive in nature. This means that users do not realise there has been a problem until after all the results have been entered"
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.
• Simcyp: contact details and other news
• Email this article to a colleague
• Register for the free Laboratorytalk email newsletter
• Laboratorytalk Home Page
Search the Pro-Talk network of sites
