Simcyp
From Wikipedia, the free encyclopedia
Simcyp is a University of Sheffield spin-out company that develop algorithms along with population and drug databases for modelling and simulation (M&S) of the absorption and disposition of drugs in patients and specific subgroups of patients across different age ranges. The Simcyp models use experimental data generated routinely during pre-clinical drug discovery and development from in vitro enzyme and cellular systems, as well as any relevant physico-chemical attributes of the drug and dosage forms.[1]
The Simcyp Population-based ADME Simulator, Simcyp Simulator, is licensed to Simcyp's Consortium member clients for use in drug discovery and development. The Consortium guides scientific development at Simcyp, ensuring that platform and databases continue to meet industry needs. The company maintains strong academic links and its science team conducts internationally recognised cutting-edge research and development which accelerates decision making in drug discovery and development for member pharmaceutical companies.
The company:
• provides a user friendly simulator that integrates genetic information on drug metabolising enzymes into PBPK models for the prediction of drug disposition in diverse patient populations with relevant demographic and physiological characteristics,
• offers consultancy and advice on a broad spectrum of DMPK issues (including optimal study design for metabolic drug-drug interactions, data interpretation, prediction of in vivo ADME from in vitro studies, dose selection for different age groups particularly in neonates and young children, assessing the likely effects of renal impairment, cirrhosis and ethnic variations on ADME, etc)
• delivers an educational program consisting of hands-on workshops and courses covering concepts and applications of in vitro - in vivo extrapolation (IVIVE) to predict drug clearance, drug-drug interactions, gut absorption handling metabolism/transport interplay, and covariates that determine drug disposition (see Simcyp Workshops[1].)
Currently, 9 of the top 10 pharmaceutical companies worldwide have access to Simcyp expertise through Consortium membership. The aim of the Consortium is to help members enhance the utilisation of information from pre-clinical development in the rational selection and design of in vivo studies. Value is added to decision-making processes by collaboration with regulatory bodies (the FDA, MPA, NAM, ECVAM) and academic centres of excellence worldwide, also within the framework of the Consortium.
The Simcyp Simulator is capable of predicting drug absorption, clearance and metabolic drug-drug interactions and PBPK modelling from in vitro and physiochemical information in diverse populations including paediatric, obese, liver cirrhosis and renally impaired. Some details of the scientific background to Simcyp approaches can be found in recent publications. [2][3][4][5]
[edit] References
- ^ Amin Rostami-Hodjegan; Geoffrey Tucker (2007). "Simulation and prediction of in vivo drug metabolism in human populations from in vitro data". Nature Reviews Drug Discovery 6 (2): 140-148.
- ^ Yang JS, Jamei M, Yeo KR, Tucker GT, Rostami-Hodjegan A. (2007). "Prediction of intestinal first-pass drug metabolism.". Current Drug Metabolism 8 (7): 676-684.
- ^ Yang JS, Jamei M, Yeo KR, Tucker GT, Rostami-Hodjegan A. (2007). "Theoretical assessment of a new experimental protocol for determining kinetic values describing mechanism (time)-based enzyme inhibition.". Eur J Pharma Sci 31 (3-4): 232-241.
- ^ Perrett HP et al. (2007). "Disparity in holoprotein/apoprotein ratios of different standards used for immunoquantification of hepatic cytochrome P450 enzymes.". Drug Metabolism & Disposition 35 (10): 1733-1736.
- ^ Yang JS, Jamei M, Yeo KR, Tucker GT, Rostami-Hodjegan A. (2007). "Misuse of the Well-Stirred Model of Hepatic Drug Clearance, Drug Metabolism and Disposition". Drug Metabolism & Disposition. 35 (3): 501-502.
