The Simcyp consortium
Simcyp
Simcyp Simulator – a user-friendly IVIVE-PBPK platform and database for mechanistic modelling, simulation and prediction of drug absorption, tissue distribution, metabolism, transport, elimination and drug-drug interactions in healthy and disease populations using in vitro and in vivo knowledge and PBPK modelling technology
Developing a user-friendly platform that can handle a vast number of complex physiologically based pharmacokinetic and pharmacodynamic (PBPK/PD) models both for conventional small molecules and larger biologic drugs is a substantial challenge. The Simcyp Population Based Simulator is currently used by the majority of large pharmaceutical companies (70% of top 40 – in term of R&D spending) and has impacted more than 20 NDA labelling packages in the past 3 years.
Under the guidance of the Simcyp consortium the Simulator has evolved from a simple drug-drug interaction tool to a sophisticated and comprehensive PBPK-Model-Informed Drug Development (PBPK-MIDD) platform that covers a broad range of applications spanning from early drug discovery to late drug development, from small molecules to large molecules including antibody-drug conjugates (ADC), encompassing PBPK models for simulating drug disposition in pre-clinical species (mouse, rat, dog and monkey) and in a variety of human populations (including adult Caucasian, Japanese and Chinese populations as well as paediatric, pregnancy, obesity, hepatic and renal impairment populations).
In the demonstration session we will provide an update on the latest architectural and implementation developments within the small molecule and biologics simulators, as well as offering demonstrations of SIVA (Simcyp In vitro Data Analysis Tool) and CSS (Cardiac Safety Simulator).
Some details of the scientific background to Simcyp’s approaches can be found in our recent publications:
Prediction of drug-drug interactions arising from CYP3A induction using a physiologically-based dynamic model.
Almond LM, Mukadam S, Gardner I, Okialda K, Wong S, Hatley O, Tay S, Rowland-Yeo K, Jamei M, Rostami-Hodjegan A, Kenny JR. Drug Metab Dispos. 2016 Mar 29. pii: dmd.115.066845
Metformin and cimetidine: Physiologically based pharmacokinetic modelling to investigate transporter mediated drug-drug interactions.
Burt HJ, Neuhoff S, Almond L, Gaohua L, Harwood M, Jamei M, Rostami-Hodjegan A, Tucker GT, Rowland-Yeo K. Eur J Pharm Sci. 2016 Mar 24. pii: S0928-0987(16)30093-8. doi: 10.1016/j.ejps.2016.03.020.
Considering Age Variation when Coining Drugs as High vs Low Hepatic Extraction Ratio.
Salem F, Abduljalil K, Kamiyama Y, Rostami-Hodjegan A. Drug Metab Dispos. 2016 Feb 10. pii: dmd.115.067595.
A Bottom-Up Whole-Body Physiologically Based Pharmacokinetic Model to Mechanistically Predict Tissue Distribution and the Rate of Subcutaneous Absorption of Therapeutic Proteins.
Gill KL, Gardner I, Li L, Jamei M. AAPS J. 2016 Jan;18(1):156-70. doi: 10.1208/s12248-015-9819-4.
Reference: PAGE 25 (2016) Abstr 6065 [www.page-meeting.org/?abstract=6065]
Poster: Software Demonstration