Dosing of children's medicine
Simcyp well placed to capitalize on House of Lords drug testing report
A report published by the House of Lords EU Sub-Committee on Social Policy and Consumer Affairs has highlighted that 90% of medicines given to newborn babies have only been tested on adults, and that half of drugs given to children have not been tested adequately in children. The Committee was reporting on the European Commission's proposals for paediatric medicines and their attempts to set up a common EU-wide procedure for testing and approving medicines for use in children.
This is a longstanding issue, and one which has been a focus of attention within Simcyp Limited, a Biofusion spin-out company from the University of Sheffield, which specialises in the development of software that assists the pharmaceutical industry in predicting the behaviour of drugs and new drug candidates in the body.
Traditionally drug dosages for babies and young children were simply scaled down from those in adults based on body weight or body surface area. Dr Trevor Johnson, of Simcyp and the Sheffield Children's Hospital, has shown that this approach may result in up to 3-fold under or over dosing.
Simcyp Paediatric, a module within the Simcyp Interaction and Clearance software platform, used by most of the major global pharmaceutical companies, analyses developmental changes that affect the handling of drugs in neonates, infants and children, to assist in the establishment of safe and effective doses. By using Simcyp Paediatric, pharmaceutical companies will be able to predict doses that should result in drug exposure similar to that in adults.
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