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Dr. Paulo Paixão

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Paulo Paixão has been an Assistant Professor in Pharmacokinetics and Biopharmaceutics at the Pharmacy Faculty of Lisbon University since 2012. He has also been a Clinical Pharmacology assessor at INFARMED (Portuguese Regulatory Agency) since 2003 and a member of the PKWP from EMA. In his regulatory work, he has been Involved in the assessment of bioequivalence and general clinical pharmacokinetics in Centralized, Decentralized, Mutual recognition and National Procedures. He has also been Involved in Scientific Advice Procedures both at the National and European level. Regarding research, his main topics of interest have been related to pharmacokinetics and Therapeutic Drug Monitoring. In particular, he has been involved in creating and optimizing drug development tools, namely on the use of QSAR and data integration procedures with PBPK models. Regarding PBPK models, he has mainly been focused in modelling and simulation on oral drug absorption, with several papers with direct implications for bioavailability/bioequivalence regulatory sciences, namely on the establishment of pharmacokinetics metrics for bioequivalence of modified release formulations, and on the evaluation of similarity metrics for dissolution profiles. The latter research interests are related to the better understanding of the physiology of the GI tract and its consequences in clinical variability for oral drug products.

Short Biography

Paulo Paixão has been an Assistant Professor in Pharmacokinetics and Biopharmaceutics at the Pharmacy Faculty of Lisbon University since 2012. He has also been a Clinical Pharmacology assessor at INFARMED (Portuguese Regulatory Agency) since 2003 and a member of the PKWP from EMA. In his regulatory work, he has been Involved in the assessment of bioequivalence and general clinical pharmacokinetics in Centralized, Decentralized, Mutual recognition and National Procedures. He has also been Involved in Scientific Advice Procedures both at the National and European level. Regarding research, his main topics of interest have been related to pharmacokinetics and Therapeutic Drug Monitoring. In particular, he has been involved in creating and optimizing drug development tools, namely on the use of QSAR and data integration procedures with PBPK models. Regarding PBPK models, he has mainly been focused in modelling and simulation on oral drug absorption, with several papers with direct implications for bioavailability/bioequivalence regulatory sciences, namely on the establishment of pharmacokinetics metrics for bioequivalence of modified release formulations, and on the evaluation of similarity metrics for dissolution profiles. The latter research interests are related to the better understanding of the physiology of the GI tract and its consequences in clinical variability for oral drug products.