Pharmacometrics

Imagen subrayado titulo

Pharmacometrics is the science of quantitative pharmacology and supports efficient drug development and/or regulatory decisions. 

  • Population PK

    Focus on data driven models supporting mainly new drug and formulation development covering small and large molecules. 

    • Phase I, II, III clinical trials
    • Routine clinical data
    • Time & Dose dependent PK
    • Target-mediated Drug Disposition
    • Covariate selection & evaluation
    • Sustained release formulations
    • Micro- & Nanoparticles
    • In vitro-in vivo correlation


    Buil-Bruna et al Clin Pharmacokinet (2016)

  • Population PK PD

    Focus on mechanistic-based predictive models supporting basic research and new drug and formulation development covering a wide range of therapeutic areas.

    • In vitro, ex vivo & in vivo data models
    • Models from combination therapies
    • Disease progression and Baseline models
    • Delayed continuous and non-continuous responses
    • Latent response analysis
    • Covariate selection & evaluation
    • Phase I, II, III clinical trials


    Parra-Guillen et al J Pharmacol Exp Ther (2013)

  • Translational approach

    Focus on predicting clinical outcomes using mechanistic models developed at earlier stages, and using the concept of system, disease, and drug action specific parameters.

    • Predicting clinical response from pre-clinical PKPD models
    • Mechanistic PK and PKPD
    • Biomarker response to clinical outcome

     

  • Personalised medicine

    Optimised and improved patient specific therapeutic strategies through the use of population PKPD models using early and limited patient data 

    • Oncology
    • Auto-immune diseases
    • Anti-infectives
    • Immuno-oncology


    Buil Bruna et al Cancer Res (2015)

  • Optimal control

    Help designing biopharmaceutics taking into account critical aspects of the response profiles, absorption & pharmacokinetic properties.

    • Single- & multi-objectives
    • Sustained release formulation
    • Time to next administration tim
    • Chronic diseases

    Optimal

    Adapted from Romero et al J Pharmacol Exp Ther (2012)