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Giovanni Smania

Giovanni Smania

Giovanni Smania, Ph.D.

Principal Director, MIDD Consultant

Google scholar

Joined Pharmetheus in 2018, actively working in client projects, serving as Project Portfolio Team Leader
Expertise includes MIDD in early and late phase projects in therapeutic areas such as oncology and cardiometabolic disease
Previously worked as Clinical Pharmacology and Pharmacometrics Specialist at Menarini Ricerche, Italy, and as Research Fellow at CVBF, Italy
M.Sc. in Bioengineering (2013) from University of Padova, Italy, and Ph.D. in Pharmacometrics (2017) from University of Pavia, Italy

Pharmetheus affiliated publications

Model-informed pediatric drug development for clevidipine 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 Concentration-QTcF analysis of quizartinib in patients with newly diagnosed FLT3-internal-tandem-duplication-positive acute myeloid leukemia Population pharmacokinetic analysis of quizartinib in patients with newly diagnosed FLT3-internal-tandem-duplication-positive acute myeloid leukemia Population pharmacokinetics of survodutide in subjects with overweight or obesity with and without Type 2 Diabetes Mellitus based on Phase I and Phase II data Exploring the relationship between BI 456906 exposure and change in fasting plasma glucose, fasting serum insulin, and glycated hemoglobin (HbA1c) using population PKPD modeling Concentration-QTcF Analysis of Quizartinib in Patients With Newly Diagnosed (ND) Acute Myeloid Leukemia (AML) Population Pharmacokinetics (PopPK) of Quizartinib and Its Active Metabolite AC886 in Patients (Pts) With Newly Diagnosed (ND) Acute Myeloid Leukemia (AML) Investigating the Identifiability of One-Stage IVIVC Population Models for Extended-Release Dosage Forms Conditional Distribution Modeling for Covariates Simulation Using Classification and Regression Trees Methods Conditional Distribution Modeling as an Alternative Method for Covariates Simulation: Comparison with Joint Multivariate Normal and Bootstrap Techniques 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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