Fundació URV

Predictive pharmacokinetics/ pharmacodynamic (system biology) evaluation of drug and other compound’s efficacy and safety

Posted by Fundació URVResponsive · Innovative Products and Technologies · Spain

Summary of the technology

Pharmacokinetics/ pharmacodynamic (system biology) PBPK/PD model is a powerful mechanistic tool used for designing of trials in different phases, prospective and retrospective analysis for bridging gaps in an experiment, target validation, safety and efficacy analysis and early identification of risk associated with specific group of population.

Description of the technology

TecnATox, innovation Center of the University Rovira i Virgili, can provide tailored consultancy for predictive pharmacokinetics and system biology, stratified evaluation of drug/other compound’s efficacy and safety and animal trial design and cross-species translation. In collaboration with our partner organisations, we can provide full range of in silico modelling support to pharmaceutical, cosmetic, food, animal feed and other consumer chemicals industries.
TecnATox provides wide range of in silico modelling support for the entire life cycle of drug discovery process from early prediction of first-in human dose to tailored made dosage regimen for specific population (geriatric, paediatric and diseased). One of our expertise is cellular and physiological based pharmacokinetic/ pharmacodynamic (PBPK/PD) modeling, and simulation. PBPK/PD is a powerful mechanistic tool used for designing of trials in different phases, prospective and retrospective analysis for bridging gaps in an experiment, target validation, safety and efficacy analysis and early identification of risk associated with specific group of population (precautionary step).
Preclinical trials: species extrapolation along with in vitro- in vivo correlation, Prediction of ADME (absorption, distribution, metabolism, and excretion) and identification of first-in human dose for further trials, simulation for different dosing scenario for safety and efficacy analysis, determination of NOAEL in preclinical species by applying system biology approach to PBPK/PD.
Phase 0: validation of model for Human studies, simulation of target and non-target tissue distribution of INDs (investigational new Drugs), target validation, Evaluation of Pharmacokinetic and pharmacodynamic relationship help in “go-no-go” decision making (proof mechanism), sensitivity analysis of parameters for establishing relationship between safety and efficacy.
Phase1: Design of clinical trial; Predict-learn confirm analysis; Simulation of the effects of specific population (disease base); Co-exposure of drug (Drug-Drug interaction) on PPPK and PD of the INDs; Prediction of exposure safety relationship.
Phase 2/3: Population based PBPK modelling; Simulation for number of clinical studies reducing experiment burden; Dosing guidance and precaution for specific populations; Mode base data integration and optimize benefits and risk ratio, support regulatory guidelines.

Specifications

Intellectual property status

Other forms of protection

Trade secret

Current development status

Commercially available technologies

Desired business relationship

Other : Consultancy agreement

Technology Owner

Unitat de Valorització de la URV

Licensing Manager at Fundació URV

Related keywords

  • Industrial Technologies
  • Genetic Engineering / Molecular Biology
  • Molecular design Market
  • Biochemistry / Biophysics Market
  • Medical Health related
  • Other Medical/Health Related

About Fundació URV

Technology Transfer Office from Spain

The Technology Transfer and Innovation Center (CTTi) meets from the University environment the technological needs and services generated by the productive sectors and administration, through the management of Transfer of Technology and Knowledge, the Intellectual and Intellectual Property management, Technology Watch, Entrepreneurship, and Technology Infrastructures Offer (business incubator).

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