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  • PEARRL Project
    • Beneficiaries
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    • People >
      • Supervisors >
        • Prof. B. Griffin
        • Prof. M. Kuentz
        • Dr. C. Saal
        • Dr. L. Kalantzi
        • Dr. E. Kostewicz
        • Prof. C. Reppas
        • Prof. J. Dressman
        • Dr. N. Fotaki
        • Dr. R. Holm
        • Dr. M. Vertzoni
        • Dr. K. Box
        • Prof. C. O'Driscoll
      • Researchers >
        • Niklas Köhl (ESR1)
        • Felix Ditzinger (ESR 2)
        • Daniel Price (ESR 3)
        • Georgia Tsakiridou (ESR 4)
        • Sandra Jankovic (ESR 5)
        • Chara Litou (ESR 6)
        • Christina Pentafragka (ESR 7)
        • Rafael Leal Monteiro Paraiso (ESR 8)
        • Laura Henze (ESR 9)
        • Patrick O'Dwyer (ESR 10)
        • Marina Statelova (ESR 11)
        • Mariana Guimarães (ESR 12)
        • Ioannis Loisios-Konstantinidis (ESR 13)
        • Alexandra-Roxana Ilie (ESR 14)
        • Angela Effinger (ESR 15)
      • Scientific Advisory Board >
        • Prof. Carla Caramella
        • Dr. Paul Dickinson
        • Dr. Andrea Edginton
        • Dr. Susanne Keitel
        • Dr. Mehul Mehta
    • PEARRL Wiki >
      • FAQ
      • Glossary
  • Research
    • Workplan
    • WP1: Bio-enabling formulations
    • WP2: Biopharmaceutical tools
    • WP3: In silico methods
    • Results >
      • Scientific Publications
      • Conference Contributions
      • InfoPEARRLs
      • Media
  • Training
    • Local
    • Network-wide
    • PEARRL Online Learning Portal
    • Member Area
  • News
  • Events & Meetings
    • Webinar: Regulatory Science Apprentice
    • Annual Meeting 2019
    • Model Informed Drug Development Symposium 2019
    • Annual Meeting 2018
    • Regulatory Science Symposium 2018
    • Annual Meeting 2017
    • Regulatory Science Symposium 2017
    • PEARRL Calendar
    • International Conferences
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ESR 8: Rafael Leal Monteiro Paraiso
A new approach to setting bioequivalence limits using Physiologically based Pharmacokinetic (PBPK) modelling

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PEARRL research

Rafael will work with in silico software combining PBPK modelling with pharmacodynamics (PD) to link the in vitro release data from dosage forms to the clinical setting. With this approach we aim to predict the therapeutic equivalence (or lack thereof) of generic drug formulations, which is a prerequisite for marketing approval. Further, by running virtual clinical trials in special populations (e.g. children and those with GI disease), we will be able to determine whether performing bioequivalence studies in healthy subjects is an adequate approach to forecasting therapeutic equivalence in these special populations.

Host

Johann Wolfgang Goethe University, Institute of Pharmaceutical Technology

Supervisory Team

Prof. J. Dressman (JWGU), Dr. N. Fotaki (UBAH), Dr. M. McAllister (Pfizer)

Scientific Background

Rafael holds a Bachelor of Pharmacy from the Department of Health, Positivo University, Brazil (2005-2008). Further, he attended a specialization course on bioquivalence studies (2009-2010) in the course of which, he wrote a monography on “Planning and execution of bioequivalence studies; Clinical, analytical and statistical steps.”
Rafael completed his master’s degree in pharmaceutical sciences at the Department of Pharmacy, University of São Paulo, Brazil (2010-2012). His master’s thesis was entitled “Determination of Biopharmaceutical Classification of drugs Solubility and permeability studies (in vitro)”.
Contact
lealmonteiroparaiso [at] em [dot] uni-frankfurt [dot] de
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This project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement No 674909.
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