A PBPK Modeling Platform for Veterinary and Pre-clinical Drug Research
Simcyp® Animal is a whole-body physiologically-based pharmacokinetic (PBPK) modeling platform for rat, dog, and knock-out mouse. It is based on the Simcyp Simulator with simplified interfaces and well-validated models. Simulations with Simcyp Animal can help identify key data requirements and inform the design of subsequent experiments. It can also increase confidence in in vitro-in vivo extrapolation (IVIVE) before moving to human simulations. Simcyp Animal can be used to:
- Assess PK properties
- Evaluate formulation and food effects on drug absorption
- Predict concentration-time profiles in plasma, tissues and organs
- Investigate the formation and kinetics of primary metabolites
- Increased accuracy: When used in conjunction with the Simcyp Population-based Simulator, Simcyp Animal allows comparison of human and animal data without relying upon allometric scaling, which may not be a valid approach for some parameters.
- Save time: Compound import and batch processing capabilities allow large numbers of compounds to be screened quickly and sensitivity analysis to be performed.
- Satisfy ethical imperatives: Simcyp Animal helps fulfill the ethical obligation towards the refinement, replacement and reduction of in vivo studies in animals.
- Save money: The knock-out mouse simulator allows users to investigate how adding or removing specific genes controlling drug metabolizing enzymes and transporters affects the ADME properties of a drug.
- Study oral drug absorption and physiological differences in the dog gut wall with a unique mechanistic permeability (mech Peff) model.
- Incorporates intersubject physiological variability in dogs
- Databases of commonly used compounds allow researchers to validate implemented models and compare the properties of their new drugs with these reference compounds
- Transparent algorithms, methods, and visual outputs through a variety of graphical interfaces
Learn more about the science of Simcyp Animal:
- Virtual Populations
- Drug Metabolism
- Prediction of Clearance
- Prediction of Drug-Drug Interactions
Our FDA CRADA
Our five year Cooperative Research and Development Agreement (CRADA) with the FDA’s Center for Veterinary Medicine (CVM), aims to deliver PBPK dog models that streamline veterinary drug product development and evaluation. Due to the inherent flexibility of PBPK models to separate extrinsic and intrinsic factors, this collaboration will investigate the effect of these factors in combination or independently on drug kinetics, such as effect of drug formulation and food on drug exposure in animals. This will facilitate using pharmacokinetic principles to address complex questions associated with designing and interpreting animal safety studies and clinical field studies and enable integrating model predictions with data from safety and effectiveness studies to develop informative product labels.