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Simcyp paper describes paediatric PBPK models and applicability to drug development and clinical practice
Date: 01 Jun 2010
Dr Trevor Johnson, Principal Scientist at Simcyp Limited and Senior Pharmacist at Sheffield Children’s Hospital, has co-authored a paper with Professor Amin Rostami-Hodjegan, Director of Scientific Research and Development at Simcyp.
The article, to appear in the journal Pediatric Anesthesia, describes the development work required to build a paediatric physiologically-based pharmacokinetic (P-PBPK) model, namely, the Simcyp Paediatric ADME Simulator. The model was used to replicate paediatric clinical studies and undertake theoretical studies to show the potential applications of mechanistic PBPK in paediatric drug clinical investigation and practice, with emphasis on paediatric anaesthesia.
By changing the P-PBPK model parameters the authors were able to simulate a number of ‘what if’ scenarios and explore the likely underlying reasons for observed pharmacokinetic (PK) behaviour of drugs in critically ill children. Furthermore, the use of the paediatric models to predict complex drug-drug interactions (DDIs) highlighted disparities with adult populations.
The paper is entitled, ‘Resurgence in the use of physiologically-based pharmacokinetic models in pediatric clinical pharmacology: parallel shift in incorporating the knowledge of biological elements and increased applicability to drug development and clinical practice.’
Please see PubMed for the abstract and full text options.