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ESR 8: Rafael Leal Monteiro Paraiso
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PEARRL research
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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.
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Host
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Johann Wolfgang Goethe University, Institute of Pharmaceutical Technology
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Supervisory Team
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Scientific Background
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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)”. |
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Contact
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lealmonteiroparaiso [at] em [dot] uni-frankfurt [dot] de
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