Experience meets meets

Paulo PaixaoInfarmed, Portugal

Paulo Paixão, is an Assistant Professor in Pharmacokinetics and Biopharmaceutics at the Pharmacy Faculty of Lisbon University since 2012. He is also a Clinical Pharmacology assessor at INFARMED (Portuguese Regulatory Agency) since 2003, a member of the PKWP and of the newly created Methodological working party 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 providing Scientific Advice both at the National and European regulatory level.

Regarding research, his main topics of interest has 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 and other modelling approaches, he has mainly been focused in modelling and simulation on oral drug absorption with several papers with direct implication on bioavailability/bioequivalence regulatory sciences, namely on the establishment of pharmacokinetics metrics for bioequivalence of modified release formulations, on the evaluation of similarity metrics for dissolution profiles, and on statistical issues for bioequivalence assessment. 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.