Stephan Schmidt

Stephan Schmidt Ph.D., F.C.P.

Associate Professor, Associate Director CPSP, Certara Professor

Department: Pharmaceutics
Business Phone: (407) 313-7012
Business Email:

About Stephan Schmidt

Dr. Schmidt is an Associate Professor in the Department of Pharmaceutics & Associate Director of the Center for Pharmacometrics and Systems Pharmacology in Lake Nona (Orlando). He received his B.S. in Pharmaceutical Sciences from the Friedrich-Alexander University in Erlangen, Germany in 2003 and his license to practice as a pharmacist in Germany in 2005. Dr. Schmidt received his Ph.D. from the University of Florida under the supervision of Dr. Hartmut Derendorf in 2008, before completing a 3 year postdoctoral fellowship under the supervision of Prof. Meindert Danhof in the Division of Pharmacology at the Leiden/Amsterdam Center for Drug Research in The Netherlands. During his postdoctoral fellowship, Dr. Schmidt was also a member of the Dutch Top Institute Pharma PK-PD modeling platform.

Dr. Schmidt received the Paul Ehrlich Society for Chemotherapy Thesis Award in 2010, the University of Florida Clinical Translational Science Institute Junior Faculty Pilot Program Award in 2012, the University of Florida Excellence Award for Assistant Professors in 2013, the Tanabe Young Investigator Award from the American College of Clinical Pharmacology (ACCP) in 2016 and was named International Educator of the Year of the College of Pharmacy at the University of Florida in 2014. He serves as the Chair of the Special Interest Group on PK/PD and Systems Pharmacology of the International Pharmaceutical Federation (FIP) and Chair of the Systems Pharmacology Community for the American Society for Clinical Pharmacology and Therapeutics (ASCPT). Dr. Schmidt is a Section Editor for the European Journal of Pharmaceutical Sciences and Editorial Board Member for the Journal of Clinical Pharmacology and ASCPT’s Pharmacometrics and Systems Pharmacology journal.

Research Profile

His research focuses on the application of Pharmacometrics and Systems Pharmacology tools to address clinically relevant research questions in the area of antimicrobial chemotherapy, pediatrics, diabetes, cardiovascular safety and post-menopausal osteoporosis. Dr. Schmidt published more than 60 peer-reviewed articles in highly respected journals in the clinical pharmacology arenas well as 6 book chapters on the application of quantitative analysis techniques in various therapeutic areas. He is the editor of a book entitled, “Applied Pharmacometrics”, published in 2014 as part of an AAPS series on advancing Pharmaceutical Sciences.



August 2019ACTIVE
Pharmacometrics Modeling and Simulation of Probe Drugs Profiles Subjected to Competitive Enzyme Inhibition under Various Drug Administration Conditions
TABULA RASA HEALTHCARE · Principal Investigator
July 2019ACTIVE
Microdialysis study of Lipo680 in the animal model
GLAXO SMITHKLINE · Principal Investigator
July 2019ACTIVE
Clinical Pharmacokinetics/Dynamics Fellowship 2019-2020 – Mohammad Akbar
GLAXO SMITHKLINE · Principal Investigator
November 2018ACTIVE
Development of a Mechanism-Based Drug Disease Trial Model for Parkinsons disease (PD)
August 2018ACTIVE
Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
July 2018 – June 2019
Microdialysis study of Lipo680 in the animal model
GLAXO SMITHKLINE · Principal Investigator
July 2018ACTIVE
Development and qualification of an expanded Diabetes model
ELI LILLY AND CO · Principal Investigator
July 2018 – June 2019
Clinical Pharmacokinetics/Dynamics Fellowship 2018-2019
GLAXO SMITHKLINE · Principal Investigator
July 2018 – June 2019
Clinical Pharmacokinetics/Dynamics Fellowship 2018-2019 – Mohammad Akbar
GLAXO SMITHKLINE · Principal Investigator
November 2017ACTIVE
Application of physiologically-based pharmacokinetic models to inform dosing recommendations for hormonal contraceptives co-administered with other medications
GATES FOU, BILL & MELINDA · Principal Investigator
January 2017 – January 2019
Improved pediatric dose selection through physiologically based pharmacokinetic modeling
F Hoffmann La Roche LTD · Principal Investigator
August 2016ACTIVE
Optimizing combination therapy for accelerate clinical cure of tuberculosis
July 2016 – December 2018
Clinical Pharmacokinetic/Dynamics Fellowship
GLAXO SMITHKLINE · Principal Investigator
November 2015 – August 2017
Research Fellowship Program for Pharmacokinetics
GLAXO SMITHKLINE · Principal Investigator
October 2015 – October 2018
Translational Research Institute for Metabolism and Diab
August 2015 – August 2016
Pediatric PBPK model for large molecules in PK-Sim
BAYER TECHNOLOGY SERVICES · Principal Investigator
April 2015 – February 2017
In Silico Clinical Trial Qualification of Successful Bio
April 2015 – October 2017
Systems Pharmacology Based Modeling as a Platform for
ASTRAZENECA · Principal Investigator
September 2014 – February 2019
Pharmacokinetic and Pharmacodynamic (PK-PD) Studies of Cardiovascular Drugs
US FOOD AND DRUG ADMN · Project Manager
September 2014 – August 2018
A Model- and Systems-based Approach to Efficacy and Safety Questions Related to Generic Substitution
US FOOD AND DRUG ADMN · Principal Investigator
April 2013 – December 2016
In Silico Modeling of Biomarkers and Surrogate Endpoints
ELI LILLY AND CO · Principal Investigator
July 2007 – August 2016
Clinical and Translational Science Institute
UF RESEARCH FOU · Project Manager


University of Florida
Friedrich-Alexander University