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Enrica Mezzalana

Enrica Mezzalana

Enrica Mezzalana, Ph.D.

Senior Director, MIDD Consultant

Google scholar

Joined Pharmetheus in 2019, actively working in client projects and with continuous improvements
Expertise includes pharmacometrics (especially time-to-event models and target-mediated drug disposition models) and physiological based pharmacokinetic modeling (PBPK, mainly for drug-drug interactions) in therapeutic areas such as oncology, pain, and diabetes
Previously worked as Modeling and Simulation Scientist at SGS Exprimo NV, Belgium, where she developed, interpreted, and reported population pharmacokinetic-pharmacodynamic models, optimal design, and physiological based pharmacokinetic modeling for drug-drug interaction predictions, as Clinical Pharmacology and Pharmacometrics Specialist at Menarini Ricerche, Italy, and as Postdoctoral Research Fellow at University of Pavia, Italy
M.Sc. in Bioengineering (2010) from the University of Padova, Italy, and Ph.D. in Bioengineering and Bioinformatics (2014) from University of Pavia, Italy

Pharmetheus affiliated publications

Food effect prediction of high permeability/low solubility, formulated as an amorphous solid dispersion (ASD) using an open systems pharmacology (OSP) PBBM approach Risks encountered when not adjusting for diurnal variation and food effect in QTcF analysis based on Phase I data Exposure-Overall Survival Analysis for Quizartinib in Newly Diagnosed Patients with FMS- Like Tyrosine Kinase 3-Internal-Tandem-Duplication-Positive Acute Myeloid Leukemia Expediting MIDD evidence generation to support quizartinib approval in newly diagnosed AML patients Model-based approach for a new Prolonged-Release (PR) formulation of ivabradine: PK and PKPD assessment to support bioequivalence Physiologically-based pharmacokinetic modeling to support submission of brigimadlin (BI 907828) in dedifferentiated liposarcoma Phase 1 interim population PK/PD modeling and recommended phase 2 dose exploration for IMM-1-104: A novel concept oral deep cyclic inhibitor of MEK Target engagement analysis of belimumab in patients with systemic lupus erythematosus (SLE) and primary Sjogren’s syndrome (pSS) Imeglimin Population Pharmacokinetics and Dose Adjustment Predictions for Renal Impairment in Japanese and Western Patients with Type 2 Diabetes Population Pharmacokinetic Modelling and Simulation of Imeglimin in Type 2 Diabetes Patients to Support Dose Recommendations to Patients with Renal Impairment Population Exposure-Response Modeling of Oral Nepadutant Administration in Infants with Colic

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Pharmetheus is a consultancy firm helping clients reduce uncertainty in technical and regulatory processes, increasing confidence in the development of new medicines that can improve patients’ lives.

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