Stephan Schmidt, Ph.D., F.C.P.
Professor And The Certara Endowed Professor; Director Of The Center For Pharmacometrics And Systems Pharmacology
About Stephan Schmidt
Dr. Schmidt is an endowed Professor in the Department of Pharmaceutics and Director of the Center for Pharmacometrics and Systems Pharmacology. 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 Profs. Meindert Danhof and Oscar Della Pasqua 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 in 2016, and the Doctoral Thesis Mentoring Award from the College of Pharmacy at the University of Florida in 2018. He was also named International Educator of the Year of the College of Pharmacy at the University of Florida in 2014 and Fellow of the American College of Clinical Pharmacology in 2017. Dr. Schmidt is a Subject Editor for the European Journal of Pharmaceutical Sciences, Editorial Board Member for the Journal of Clinical Pharmacology, and serves on the Board of Regents for the American College of Clinical Pharmacology.
Teaching Profile
Courses Taught
2012-2021,2023
PHA7980 Research for Doctoral Dissertation
2012-2023
PHA7979 Advanced Research
2014,2017-2020,2020-2023
PHA6935 Selected Topics in Pharmacy
2013,2020-2021
PHA6971 Research for Master’s Thesis
2016-2023
PHA6910 Supervised Research
2020
PHA5164L Prof Skills Lab Iv
2016-2023
PHA5132 Prin Drug Ther Indiv
2016,2018-2021,2021-2023,2023
PHA6131 Physiologically-Based Modeling
2012,2016-2021,2021-2023
PHA6125 Introduction to Quantitative Pharmacology
2012-2015
PHA5127 Dose Optimization 1
2014-2015
PHA6938 Research Seminar
2013-2014
PHA5905 Clin Pharm Research
2013
PHA5907 Research in Phar Prac
2020
PHA5930 Sem Pharm Research
2023
PHA6946 Practicum in the Pharmaceutical Sciences
Research Profile
Dr. Schmidt’s research focuses on the development and application of disease-drug-trial models in the area of chronic progressive diseases, special patient populations, and drug-drug interactions. He published more than 100 peer-reviewed scientific manuscripts, 7 book chapters, and 2 textbooks, including the fifth edition of Rowland and Tozer’s Clinical Pharmacokinetics and Pharmacodynamics textbook.
Publications
2022
A randomized, cross-over trial of metoprolol succinate formulations to evaluate PK and PD end points for therapeutic equivalence.
Clinical and translational science.
15(7):1764-1775
[DOI] 10.1111/cts.13294.
[PMID] 35488487.
2022
Application of exposure bracketing to streamline the development of contraceptive products.
Contraception: X.
4
[DOI] 10.1016/j.conx.2022.100072.
[PMID] 35243326.
2022
Application of physiologically based absorption and pharmacokinetic modeling in the development process of oral modified release generic products.
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
176:87-94
[DOI] 10.1016/j.ejpb.2022.05.007.
[PMID] 35598768.
2022
Determining the Exposure Threshold for Levonorgestrel Efficacy Using an Integrated Model Based Meta-Analysis Approach.
Clinical pharmacology and therapeutics.
111(2):509-518
[DOI] 10.1002/cpt.2457.
[PMID] 34674227.
2022
Development of a model-based clinical trial simulation platform to optimize the design of clinical trials for Duchenne muscular dystrophy.
CPT: pharmacometrics & systems pharmacology.
11(3):318-332
[DOI] 10.1002/psp4.12753.
[PMID] 34877803.
2022
Development of a Translational Exposure-Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products.
Clinical pharmacology and therapeutics.
112(4):909-916
[DOI] 10.1002/cpt.2690.
[PMID] 35723889.
2022
Evaluating the effect of clofazimine against Mycobacterium tuberculosis given alone or in combination with pretomanid, bedaquiline or linezolid.
International journal of antimicrobial agents.
59(2)
[DOI] 10.1016/j.ijantimicag.2021.106509.
[PMID] 34958863.
2022
Evaluation of a Beta-Blocker-Edema-Loop Diuretic Prescribing Cascade: A Prescription Sequence Symmetry Analysis.
American journal of hypertension.
35(7):601-609
[DOI] 10.1093/ajh/hpac013.
[PMID] 35106529.
2022
Macrolide Treatment Failure due to Drug-Drug Interactions: Real-World Evidence to Evaluate a Pharmacological Hypothesis.
Pharmaceutics.
14(4)
[DOI] 10.3390/pharmaceutics14040704.
[PMID] 35456537.
2022
Physiologically Based Pharmacokinetic Modeling to Assess the Impact of CYP2D6-Mediated Drug-Drug Interactions on Tramadol and O-Desmethyltramadol Exposures via Allosteric and Competitive Inhibition.
Journal of clinical pharmacology.
62(1):76-86
[DOI] 10.1002/jcph.1951.
[PMID] 34383318.
2021
A Pharmacoepidemiologic Approach to Evaluate Real-world Effectiveness of Hormonal Contraceptives in the Presence of Drug-drug Interactions.
Epidemiology (Cambridge, Mass.).
32(2):268-276
[DOI] 10.1097/EDE.0000000000001302.
[PMID] 33196560.
2021
Application of a dual mechanistic approach to support bilastine dose selection for older adults.
CPT: pharmacometrics & systems pharmacology.
10(9):1006-1017
[DOI] 10.1002/psp4.12671.
[PMID] 34157202.
2021
Building Optimal Three-Drug Combination Chemotherapy Regimens To Eradicate Mycobacterium tuberculosis in Its Slow-Growth Acid Phase.
Antimicrobial agents and chemotherapy.
65(10)
[DOI] 10.1128/AAC.00693-21.
[PMID] 34339275.
2021
Characterization of Hepatic UDP-Glucuronosyltransferase Enzyme Abundance-Activity Correlations and Population Variability Using a Proteomics Approach and Comparison with Cytochrome P450 Enzymes.
Drug metabolism and disposition: the biological fate of chemicals.
49(9):760-769
[DOI] 10.1124/dmd.121.000474.
[PMID] 34187837.
2021
Comparison of contraceptive failures associated with CYP3A4-inducing drug-drug interactions by route of hormonal contraceptive in an adverse event reporting system.
Contraception.
103(4):222-224
[DOI] 10.1016/j.contraception.2020.12.002.
[PMID] 33345974.
2021
Development and Verification of a Body Weight-Directed Disease Trial Model for Glucose Homeostasis.
Journal of clinical pharmacology.
61(2):234-243
[DOI] 10.1002/jcph.1728.
[PMID] 32895980.
2021
Dose Fractionation of Moxifloxacin for Treatment of Tuberculosis: Impact of Dosing Interval and Elimination Half-Life on Microbial Kill and Resistance Suppression.
Antimicrobial agents and chemotherapy.
65(4)
[DOI] 10.1128/AAC.02533-20.
[PMID] 33468465.
2021
In Vitro Pharmacokinetic/Pharmacodynamic Modelling and Simulation of Amphotericin B against Candida auris
Pharmaceutics.
13(11)
[DOI] 10.3390/pharmaceutics13111767.
[PMID] 34834182.
2021
In Vitro Synergistic Interactions of Isavuconazole and Echinocandins against Candida auris
Antibiotics (Basel).
10(4)
[DOI] 10.3390/antibiotics10040355.
[PMID] 33800601.
2021
Model-Informed Optimization of a Pediatric Clinical Pharmacokinetic Trial of a New Spironolactone Liquid Formulation.
Pharmaceutics.
13(6)
[DOI] 10.3390/pharmaceutics13060849.
[PMID] 34201093.
2021
Physiologically-based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate.
CPT: pharmacometrics & systems pharmacology.
10(3):199-210
[DOI] 10.1002/psp4.12589.
[PMID] 33449439.
2021
Quantitative Assessment of Levonorgestrel Binding Partner Interplay and Drug-Drug Interactions Using Physiologically Based Pharmacokinetic Modeling.
CPT: pharmacometrics & systems pharmacology.
10(1):48-58
[DOI] 10.1002/psp4.12572.
[PMID] 33217171.
2021
Quantitative Benefit-Risk Assessment of P-gp-Mediated Drug-Drug Interactions of Dabigatran Coadministered With Pharmacokinetic Enhancers in Patients With Renal Impairment.
Clinical pharmacology and therapeutics.
109(1):193-200
[DOI] 10.1002/cpt.2087.
[PMID] 33073366.
2021
The Funnel: a Screening Technique for Identifying Optimal Two-Drug Combination Chemotherapy Regimens.
Antimicrobial agents and chemotherapy.
65(2)
[DOI] 10.1128/AAC.02172-20.
[PMID] 33199386.
2021
Tribute to Professor Hartmut Derendorf – 1953 to 2020: Driving force in Clinical Pharmacology and Mentor Extraordinaire.
Clinical pharmacology and therapeutics.
109(4):805-809
[DOI] 10.1002/cpt.2193.
[PMID] 33667324.
2020
Association of Oral Anticoagulants and Verapamil or Diltiazem With Adverse Bleeding Events in Patients With Nonvalvular Atrial Fibrillation and Normal Kidney Function.
JAMA network open.
3(4)
[DOI] 10.1001/jamanetworkopen.2020.3593.
[PMID] 32329770.
2020
Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in patients with non-valvular atrial fibrillation.
Journal of thrombosis and thrombolysis.
50(1):20-29
[DOI] 10.1007/s11239-020-02077-9.
[PMID] 32323192.
2020
Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in the prevention of venous thromboembolism
Journal of thrombosis and thrombolysis (Dordrecht. Online).
50(1):12-19
[DOI] 10.1007/s11239-020-02078-8.
[PMID] 32323190.
2020
Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in the treatment of venous thromboembolism
Journal of thrombosis and thrombolysis (Dordrecht. Online).
50(1):1-11
[DOI] 10.1007/s11239-020-02073-z.
[PMID] 32323191.
2020
Breaking the rules for studies using real-world observational data: the case of direct-acting anticoagulants and antiepileptic drugs.
European heart journal. Cardiovascular pharmacotherapy.
6(3):155-156
[DOI] 10.1093/ehjcvp/pvz053.
[PMID] 31593242.
2020
Building Optimal Three-Drug Combination Chemotherapy Regimens.
Antimicrobial agents and chemotherapy.
64(11)
[DOI] 10.1128/AAC.01610-20.
[PMID] 32900682.
2020
Co- expression of human hepatic uridine diphosphate glucuronosyltransferase (UGT) proteins: Implications for ontogenetic mechanisms and isoform co-regulation
Journal of Clinical Pharmacology.
2020
Coexpression of Human Hepatic Uridine Diphosphate Glucuronosyltransferase Proteins: Implications for Ontogenetic Mechanisms and Isoform Coregulation
Journal of Clinical Pharmacology.
60(6):722-733
[DOI] 10.1002/jcph.1571.
[PMID] 31879975.
2020
Establishment of a Disease-Drug Trial Model for Postmenopausal Osteoporosis: A Zoledronic Acid Case Study.
Journal of clinical pharmacology.
60 Suppl 2:S86-S102
[DOI] 10.1002/jcph.1748.
[PMID] 33274518.
2020
Examination of Metoprolol Pharmacokinetics and Pharmacodynamics Across CYP2D6 Genotype-Derived Activity Scores.
CPT: pharmacometrics & systems pharmacology.
9(12):678-685
[DOI] 10.1002/psp4.12563.
[PMID] 33067866.
2020
Machine learning in drug discovery and development part 1 – a primer
CPT: pharmacometrics & systems pharmacology.
9(3):129-142
[DOI] 10.1002/psp4.12491.
[PMID] 31905263.
2020
Pharmacokinetics of tedizolid, sutezolid, and sutezolid-M1 in non-human primates.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
151
[DOI] 10.1016/j.ejps.2020.105421.
[PMID] 32531349.
2020
Physiologically Based Pharmacokinetic Modeling of Monoclonal Antibodies in Pediatric Populations Using PK-Sim.
Frontiers in pharmacology.
11
[DOI] 10.3389/fphar.2020.00868.
[PMID] 32595502.
2020
Population Pharmacokinetic Modeling of Acetaminophen Protein Adducts in Adults and Children.
Journal of clinical pharmacology.
60(5):595-604
[DOI] 10.1002/jcph.1555.
[PMID] 31802503.
2020
Predicting Cost-Effectiveness of Generic vs. Brand Dabigatran Using Pharmacometric Estimates Among Patients with Atrial Fibrillation in the United States.
Clinical and translational science.
13(2):352-361
[DOI] 10.1111/cts.12719.
[PMID] 32053288.
2020
Public Workshop Summary Report on FY2021 Generic Drug Regulatory Science Initiatives: Data analysis and model-based bioequivalence
Clinical Pharmacology & Therapeutics.
110(5):1190-1195
[DOI] 10.1002/cpt.2120.
[PMID] 33236362.
2020
Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr Phase 3 dose-exposure-response evaluation.
Journal of thrombosis and haemostasis : JTH.
18(7):1672-1685
[DOI] 10.1111/jth.14813.
[PMID] 32246743.
2020
Vancomycin in peritoneal dialysis: Clinical pharmacology considerations in therapy
Peritoneal dialysis international (Online).
40(4):896860819889774-393
[DOI] 10.1177/0896860819889774.
[PMID] 32065053.
2019
Acetaminophen Protein Adducts in Hospitalized Children Receiving Multiple Doses of Acetaminophen.
Journal of clinical pharmacology.
59(10):1291-1299
[DOI] 10.1002/jcph.1442.
[PMID] 31099052.
2019
An Integrated Bioinformatics and Quantitative Modeling Approach to Investigate Potential Claims of Oral Generic Drug Product Bioinequivalence: Introduction.
Journal of clinical pharmacology.
59(9):1245-1248
[DOI] 10.1002/jcph.901.
[PMID] 31087551.
2019
Bioequivalence Established Based on the Reference-Scaled Average Bioequivalence Approach Relevant to Chronic Administration of Phenytoin?: Perspectives based on Population Pharmacokinetic Modeling and Simulations
Journal of Clinical Pharmacology.
59(8):1061-1069
[DOI] 10.1002/jcph.1380.
[PMID] 30716169.
2019
Biomarkers for Personalized Medicine in Oncology: A Work in Progress
AAPS Newsmagazine.
2019
Characterization of the Ontogeny of Hepatic UDP-Glucuronosyltransferase Enzymes Based on Glucuronidation Activity Measured in Human Liver Microsomes.
Journal of clinical pharmacology.
59 Suppl 1:S42-S55
[DOI] 10.1002/jcph.1493.
[PMID] 31502688.
2019
Clinical Pharmacology Education – The Decade Ahead
Clinical Pharmacology & Therapeutics.
107(1):37-39
[DOI] 10.1002/cpt.1652.
[PMID] 31709518.
2019
Cycloserine Population Pharmacokinetics and Pharmacodynamics in Patients with Tuberculosis.
Antimicrobial agents and chemotherapy.
63(5)
[DOI] 10.1128/AAC.00055-19.
[PMID] 30858211.
2019
Effect of Moxifloxacin plus Pretomanid against Mycobacterium tuberculosis in Log Phase, Acid Phase, and Nonreplicating-Persister Phase in an In Vitro Assay.
Antimicrobial agents and chemotherapy.
63(1)
[DOI] 10.1128/AAC.01695-18.
[PMID] 30397058.
2019
Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended-Release Case Study.
Journal of clinical pharmacology.
59(9):1266-1274
[DOI] 10.1002/jcph.1433.
[PMID] 31087554.
2019
Genotype tailored treatment of mild symptomatic acid reflux in children with uncontrolled asthma (GenARA): Rationale and methods.
Contemporary clinical trials.
78:27-33
[DOI] 10.1016/j.cct.2019.01.009.
[PMID] 30659924.
2019
Hartmut Derendorf’s work on tissue distribution.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
136
[DOI] 10.1016/j.ejps.2019.104977.
[PMID] 31254643.
2019
Influence of model-predicted rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome
Therapeutic advances in cardiovascular disease (Online).
13
[DOI] 10.1177/1753944719863641.
[PMID] 31364490.
2019
Integrating Drug- and Formulation-Related Properties With Gastrointestinal Tract Variability Using a Product-Specific Particle Size Approach: Case Example Ibuprofen.
Journal of pharmaceutical sciences.
108(12):3842-3847
[DOI] 10.1016/j.xphs.2019.09.012.
[PMID] 31539541.
2019
Model-informed pediatric development applied to bilastine: Analysis of the clinical PK data and confirmation of the dose selected for the target population.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
128:180-192
[DOI] 10.1016/j.ejps.2018.11.016.
[PMID] 30468868.
2019
Open Systems Pharmacology Community-An Open Access, Open Source, Open Science Approach to Modeling and Simulation in Pharmaceutical Sciences.
CPT: pharmacometrics & systems pharmacology.
8(12):878-882
[DOI] 10.1002/psp4.12473.
[PMID] 31671256.
2019
Optimization of Experimental Conditions of Automated Glucuronidation Assays in Human Liver Microsomes Using a Cocktail Approach and Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry.
Drug metabolism and disposition: the biological fate of chemicals.
47(2):124-134
[DOI] 10.1124/dmd.118.084301.
[PMID] 30478159.
2019
Pharmacometrics, Physiologically Based Pharmacokinetics, Quantitative Systems Pharmacology-What’s Next?-Joining Mechanistic and Epidemiological Approaches.
CPT: pharmacometrics & systems pharmacology.
8(6):352-355
[DOI] 10.1002/psp4.12425.
[PMID] 31179639.
2019
Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended-Release Products.
Journal of clinical pharmacology.
59(9):1252-1263
[DOI] 10.1002/jcph.1017.
[PMID] 31087553.
2019
Population pharmacokinetic modeling to establish the role of P-glycoprotein on ciprofloxacin distribution to lung and prostate following intravenous and intratracheal administration to Wistar rats.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
127:319-329
[DOI] 10.1016/j.ejps.2018.11.007.
[PMID] 30423435.
2019
Real-World Data Approaches for Early Detection of Potential Safety and Effectiveness Signals for Generic Substitution: A Metoprolol Extended-Release Case Study.
Journal of clinical pharmacology.
59(9):1275-1284
[DOI] 10.1002/jcph.1436.
[PMID] 31087552.
2019
Reproducibility of Quantitative Systems Pharmacology Models: Current Challenges and Future Opportunities.
CPT: pharmacometrics & systems pharmacology.
8(4):205-210
[DOI] 10.1002/psp4.12390.
[PMID] 30697975.
2019
The Ontogeny of UDP-glucuronosyltransferase Enzymes, Recommendations for Future Profiling Studies and Application Through Physiologically Based Pharmacokinetic Modelling.
Clinical pharmacokinetics.
58(2):189-211
[DOI] 10.1007/s40262-018-0681-2.
[PMID] 29862468.
2019
Towards regulatory endorsement of drug development tools to promote the application of model-informed drug development in Duchenne muscular dystrophy.
Journal of pharmacokinetics and pharmacodynamics.
46(5):441-455
[DOI] 10.1007/s10928-019-09642-7.
[PMID] 31127458.
2018
A Semi-Mechanistic Population Pharmacokinetic Model of Nusinersen: An Antisense Oligonucleotide for the Treatment of Spinal Muscular Atrophy.
CPT: pharmacometrics & systems pharmacology.
7(9):581-592
[DOI] 10.1002/psp4.12323.
[PMID] 30043511.
2018
Activity of Moxifloxacin against Mycobacterium tuberculosis in Acid Phase and Nonreplicative-Persister Phenotype Phase in a Hollow-Fiber Infection Model.
Antimicrobial agents and chemotherapy.
62(12)
[DOI] 10.1128/AAC.01470-18.
[PMID] 30249693.
2018
Current strategies to streamline pharmacotherapy for older adults.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
111:432-442
[DOI] 10.1016/j.ejps.2017.10.015.
[PMID] 29032303.
2018
Development and Qualification of a Drug-Disease Modeling Platform to Characterize Clinically Relevant Endpoints in Type 2 Diabetes Trials.
Clinical pharmacology and therapeutics.
104(4):699-708
[DOI] 10.1002/cpt.998.
[PMID] 29271001.
2018
Effect of Linezolid Plus Bedaquiline Against Mycobacterium Tuberculosis in Log Phase, Acid Phase, and Nonreplicating-Persister Phase in An in Vitro Assay
Antimicrobial Agents and Chemotherapy.
62(8)
[DOI] 10.1128/AAC.00856-18;e00856-18.
2018
Effect of Linezolid plus Bedaquiline against Mycobacterium tuberculosis in Log Phase, Acid Phase, and Nonreplicating-Persister Phase in an In Vitro Assay.
Antimicrobial agents and chemotherapy.
62(8)
[DOI] 10.1128/AAC.00856-18.
[PMID] 29866874.
2018
Establishing a Multidisciplinary Framework to Study Drug-Drug Interactions of Hormonal Contraceptives: An Invitation to Collaborate.
CPT: pharmacometrics & systems pharmacology.
7(11):706-708
[DOI] 10.1002/psp4.12357.
[PMID] 30260082.
2018
Integrated Population Pharmacokinetic Analysis of Rivaroxaban Across Multiple Patient Populations
CPT: pharmacometrics & systems pharmacology.
7(5):309-320
[DOI] 10.1002/psp4.12288.
[PMID] 29660785.
2018
Linezolid Kills Acid-Phase and Nonreplicative-Persister-Phase Mycobacterium tuberculosis in a Hollow-Fiber Infection Model.
Antimicrobial agents and chemotherapy.
62(8)
[DOI] 10.1128/AAC.00221-18.
[PMID] 29866864.
2018
Massgeschneidert – Die Pharmakogenetik ebnet den Weg für erfolgreiche individualisierte Interventionen
Deutsche Apotheker Zeitung.
2018
Model Informed Dose Optimization of Dichloroacetate for the Treatment of Congenital Lactic Acidosis in Children.
Journal of clinical pharmacology.
58(2):212-220
[DOI] 10.1002/jcph.1009.
[PMID] 28914978.
2018
Non-Procrustean pathways for complex generic drugs development.
Therapeutic Delivery.
9(9):605-607
[DOI] 10.4155/tde-2018-0047.
[PMID] 30189807.
2018
Optimization of Voriconazole Therapy for the Treatment of Invasive Fungal Infections in Adults.
Clinical pharmacology and therapeutics.
104(5):957-965
[DOI] 10.1002/cpt.1012.
[PMID] 29315506.
2018
Regulatory perspectives in pharmacometric models of osteoporosis
Journal of Clinical Pharmacology.
58(5):572-585
[DOI] 10.1002/jcph.1071.
[PMID] 29485684.
2017
Analysis of a Complex Physiology-Directed Model for Inhibition of Platelet Aggregation By Clopidogrel
Discrete and Continuous Dynamical Systems.
37(2, SI):945-961
[DOI] 10.3934/dcds.2017039.
2017
Anticoagulation Endpoints With Clinical Implementation of Warfarin Pharmacogenetic Dosing in a Real-World Setting: a Proposal for a New Pharmacogenetic Dosing Approach
Clinical Pharmacology & Therapeutics.
101(5):675-683
[DOI] 10.1002/cpt.558.
[PMID] 28032893.
2017
Development and Qualification of Physiologically Based Pharmacokinetic Models for Drugs With Atypical Distribution Behavior: A Desipramine Case Study.
CPT: pharmacometrics & systems pharmacology.
6(5):315-321
[DOI] 10.1002/psp4.12180.
[PMID] 28398693.
2017
Development of an Enantioselective and Biomarker-Informed Translational Population Pharmacokinetic/Pharmacodynamic Model for Etodolac.
The AAPS journal.
19(6):1814-1825
[DOI] 10.1208/s12248-017-0138-9.
[PMID] 28875479.
2017
Genotype-guided dosing of warfarin through modeling and simulation.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
109S:S9-S14
[DOI] 10.1016/j.ejps.2017.05.017.
[PMID] 28502675.
2017
Identifying Clinically Relevant Sources of Variability: the Clopidogrel Challenge
Clinical Pharmacology & Therapeutics.
101(2):264-273
[DOI] 10.1002/cpt.459.
2017
Impact of the CYP2C19 genotype on voriconazole exposure in adults with invasive fungal infections.
Pharmacogenetics and genomics.
27(5):190-196
[DOI] 10.1097/FPC.0000000000000277.
[PMID] 28306618.
2016
A Comprehensive Review of Novel Drug-Disease Models in Diabetes Drug Development.
Clinical pharmacokinetics.
55(7):769-788
[DOI] 10.1007/s40262-015-0359-y.
[PMID] 26798033.
2016
Development of a mechanism-based pharmacokinetic/pharmacodynamic model to characterize the thermoregulatory effects of serotonergic drugs in mice.
Acta pharmaceutica Sinica. B.
6(5):492-503
[PMID] 27709018.
2016
Development of a physiology-directed population pharmacokinetic and pharmacodynamic model for characterizing the impact of genetic and demographic factors on clopidogrel response in healthy adults.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
82:64-78
[DOI] 10.1016/j.ejps.2015.10.024.
[PMID] 26524713.
2016
Evaluation of changes in oral drug absorption in preterm and term neonates for Biopharmaceutics Classification System (BCS) class I and II compounds.
British journal of clinical pharmacology.
81(1):137-47
[DOI] 10.1111/bcp.12752.
[PMID] 26302359.
2016
How Informative Are Drug-Drug Interactions of Gene-Drug Interactions?
Journal of clinical pharmacology.
56(10):1221-31
[DOI] 10.1002/jcph.743.
[PMID] 27040602.
2016
Population Pharmacokinetic Modeling of Etoposide Free Concentrations in Solid Tumor
Pharmaceutical Research.
33(7):1657-1670
[DOI] 10.1007/s11095-016-1906-4.
2016
Simultaneous Semimechanistic Population Analyses of Levofloxacin in Plasma, Lung, and Prostate to Describe the Influence of Efflux Transporters on Drug Distribution Following Intravenous and Intratracheal Administration
Antimicrobial agents and chemotherapy.
60(2):946-954
[DOI] 10.1128/AAC.02317-15.
[PMID] 26621623.
2015
A simultaneous semi-mechanistic population analysis of levofloxacin in plasma, lung and prostate to describe the influence of efflux transporters on drug distribution following intravenous and intratracheal administration
Antimicrobial Agents and Chemotherapy.
60:946-954
2015
Clinical pharmacokinetics and pharmacodynamics of clopidogrel.
Clinical pharmacokinetics.
54(2):147-66
[DOI] 10.1007/s40262-014-0230-6.
[PMID] 25559342.
2015
Quantitative clinical pharmacology for size and age scaling in pediatric drug development: A systematic review.
Journal of clinical pharmacology.
55(11):1207-17
[DOI] 10.1002/jcph.555.
[PMID] 26009792.
2015
Sobol Sensitivity Analysis: A Tool to Guide the Development and Evaluation of Systems Pharmacology Models.
CPT: pharmacometrics & systems pharmacology.
4(2):69-79
[DOI] 10.1002/psp4.6.
[PMID] 27548289.
2014
A Semi-Physiological Population Pharmacokinetic/Pharmacodynamic Model for the Development of a Bedside-Ready Dosing Algorithm for Clopidogrel.
Clinical Pharmacology & Therapeutics.
95(1)
2014
Application of pharmacokinetic/pharmacodynamic modelling and simulation for the prediction of target attainment of ceftobiprole against meticillin-resistant Staphylococcus aureus using minimum inhibitory concentration and time-kill curve based approaches.
International journal of antimicrobial agents.
43(1):60-7
[DOI] 10.1016/j.ijantimicag.2013.08.016.
[PMID] 24183800.
2014
Clinical implementation of genetic testing in medicine: a US regulatory science perspective.
British journal of clinical pharmacology.
77(4):606-11
[DOI] 10.1111/bcp.12299.
[PMID] 24286486.
2014
Development of a population pharmacokinetic model characterizing the tissue distribution of azithromycin in healthy subjects.
Antimicrobial agents and chemotherapy.
58(11):6675-84
[DOI] 10.1128/AAC.02904-14.
[PMID] 25155592.
2014
Model-based assessment of dosing strategies in children for monoclonal antibodies exhibiting target-mediated drug disposition.
CPT: pharmacometrics & systems pharmacology.
3(10)
[DOI] 10.1038/psp.2014.38.
[PMID] 25271939.
2014
Reduced Subcutaneous Tissue Distribution of Cefazolin in Morbidly Obese Versus Non-Obese Patients Determined Using Clinical Microdialysis
Journal of Antimicrobial Chemotherapy.
69(3):715-723
[DOI] 10.1093/jac/dkt444.
[PMID] 24214905.
2013
A negative feedback model for a mechanism based description of longitudinal observations: application for bone turnover markers
Methods of Information in Medicine.
52(6):484-493
[DOI] 10.3414/ME12-01-0076v.
[PMID] 23907233.
2013
Application of a Mechanism-Based Disease Systems Model for Osteoporosis To Clinical Data
Journal of Pharmacokinetics and Pharmacodynamics.
40(2):143-156
[DOI] 10.1007/s10928-012-9294-9.
[PMID] 23315144.
2013
Application of physiologically based pharmacokinetic modeling to predict acetaminophen metabolism and pharmacokinetics in children.
CPT: pharmacometrics & systems pharmacology.
2(10)
[DOI] 10.1038/psp.2013.55.
[PMID] 24132164.
2013
Importance of relating efficacy measures to unbound drug concentrations for anti-infective agents.
Clinical microbiology reviews.
26(2):274-88
[DOI] 10.1128/CMR.00092-12.
[PMID] 23554417.
2013
Systems approaches in risk assessment.
Clinical pharmacology and therapeutics.
93(5):413-24
[DOI] 10.1038/clpt.2013.29.
[PMID] 23531724.
2013
When is protein binding important?
Journal of pharmaceutical sciences.
102(9):3458-67
[DOI] 10.1002/jps.23559.
[PMID] 23650013.
2012
Individualization of Drug Therapy: History, Present State, and Opportunities for the Future
Clinical Pharmacology & Therapeutics.
92(4):458-466
[DOI] 10.1038/clpt.2012.113.
[PMID] 22948891.
2011
Coping with time scales in disease systems analysis: application to bone remodeling
Journal of Pharmacokinetics and Pharmacodynamics.
38(6):873-900
[DOI] 10.1007/s10928-011-9224-2.
[PMID] 22028207.
2011
Pharmacokinetic-pharmacodynamic relationships of central nervous system effects of scopolamine in healthy subjects.
British journal of clinical pharmacology.
71(6):886-98
[DOI] 10.1111/j.1365-2125.2011.03936.x.
[PMID] 21306419.
2010
Significance of protein binding in pharmacokinetics and pharmacodynamics.
Journal of pharmaceutical sciences.
99(3):1107-22
[DOI] 10.1002/jps.21916.
[PMID] 19852037.
2010
Underdosing of Ertapenem in Critically Ill Patients With Pneumonia Confirmed By Monte Carlo Simulations
International Journal of Antimicrobial Agents.
35(1):96-97
[DOI] 10.1016/j.ijantimicag.2009.09.007.
[PMID] 19896806.
2009
Ceftobiprole: a novel cephalosporin with activity against Gram-positive and Gram-negative pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).
International journal of antimicrobial agents.
34(1):1-7
[DOI] 10.1016/j.ijantimicag.2008.12.012.
[PMID] 19261449.
2009
Clinical pharmacokinetics and pharmacodynamics of tigecycline.
Clinical pharmacokinetics.
48(9):575-84
[DOI] 10.2165/11317100-000000000-00000.
[PMID] 19725592.
2009
Effects of Plasma Protein Binding On Half-Life of Elimination
.
49
2009
Pharmacokinetic-pharmacodynamic modeling of the in vitro activities of oxazolidinone antimicrobial agents against methicillin-resistant Staphylococcus aureus.
Antimicrobial agents and chemotherapy.
53(12):5039-45
[DOI] 10.1128/AAC.00633-09.
[PMID] 19786607.
2009
Pharmacokinetic/pharmacodynamic modelling and in vitro simulation of dynamic voriconazole-Candida interactions.
International journal of antimicrobial agents.
34(3):240-5
[DOI] 10.1016/j.ijantimicag.2009.02.006.
[PMID] 19339162.
2009
Soft tissue penetration of cefuroxime determined by clinical microdialysis in morbidly obese patients undergoing abdominal surgery.
International journal of antimicrobial agents.
34(3):231-5
[DOI] 10.1016/j.ijantimicag.2009.03.019.
[PMID] 19411164.
2009
Soft-tissue penetration of ceftobiprole in healthy volunteers determined by in vivo microdialysis.
Antimicrobial agents and chemotherapy.
53(7):2773-6
[DOI] 10.1128/AAC.01409-08.
[PMID] 19364847.
2008
A pharmacokinetic/pharmacodynamic mathematical model accurately describes the activity of voriconazole against Candida spp. in vitro.
International journal of antimicrobial agents.
31(4):369-74
[DOI] 10.1016/j.ijantimicag.2007.11.015.
[PMID] 18215509.
2008
Clinical microdialysis in skin and soft tissues: an update.
Journal of clinical pharmacology.
48(3):351-64
[DOI] 10.1177/0091270007312152.
[PMID] 18285620.
2008
Combination of Clinical Microdialysis and in Vitro Pharmacodynamics for Dose Optimization of Beta-Lactam Antibiotics
.
48
2008
Effect of protein binding on the pharmacological activity of highly bound antibiotics.
Antimicrobial agents and chemotherapy.
52(11):3994-4000
[DOI] 10.1128/AAC.00427-08.
[PMID] 18779351.
2008
PK/PD: new insights for antibacterial and antiviral applications.
Current opinion in pharmacology.
8(5):549-56
[DOI] 10.1016/j.coph.2008.06.010.
[PMID] 18625339.
2008
Soft Tissue Penetration of Cefuroxime Determined By Clinical Microdialysis in Six Obese Patients Undergoing Abdominal Surgery
.
48
2007
Integration of pharmacokinetic/pharmacodynamic modeling and simulation in the development of new anti-infective agents – minimum inhibitory concentration versus time-kill curves.
Expert opinion on drug discovery.
2(6):849-60
[DOI] 10.1517/17460441.2.6.849.
[PMID] 23489002.
2007
Pharmacokinetic/pharmacodynamic modeling of in vitro activity of azithromycin against four different bacterial strains.
International journal of antimicrobial agents.
29(3):263-70
[PMID] 17194570.
2006
Penetration of ertapenem into skeletal muscle and subcutaneous adipose tissue in healthy volunteers measured by in vivo microdialysis.
The Journal of antimicrobial chemotherapy.
58(3):632-6
[PMID] 16840426.
2004
Discriminatory features of acute transverse myelitis: a retrospective analysis of 45 patients.
Journal of the neurological sciences.
217(2):217-23
[PMID] 14706227.
Grants
Mar 2023
ACTIVE
Model Integrated Evidence Approach for Intravesical Drug Delivery for Localized Bladder Disease
Role: Co-Project Director/Principal Investigator
Funding: JANSSEN RESEARCH AND DEVELOPMENT
Feb 2023
ACTIVE
A Phase III, Single-arm, Open-label, International, Multi-centre Study to Evaluate the Efficacy and Safety of Lomitapide in Paediatric Patients with Homozygous Familial Hypercholesterolaemia (HoFH) on Stable Lipid-lowering Therapy
Role: Principal Investigator
Funding: AMRYT PHARMA
Dec 2022
ACTIVE
GSK-UF Fellowship funding agreement 2022-23 Ana Conchon Costa
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
Nov 2022
ACTIVE
Characterizing efficacy and safety of hormonal contraceptives by combining pharmacometrics and RWE
Role: Principal Investigator
Funding: GATES FOU, BILL & MELINDA
Sep 2022
ACTIVE
Genentech Travel Compensation
Role: Principal Investigator
Funding: GENENTECH INC
Sep 2022
ACTIVE
Opioid Prescribing Practices and Health Outcomes among Patients with Alzheimers Disease and Related Dementia
Role: Co-Investigator
Funding: OHIO STATE UNIV
via NATL INST OF HLTH NIA
Aug 2022
ACTIVE
Integrative disease-drug-trial platform for Neurodegenerative diseases
Role: Co-Investigator
Funding: TAKEDA DEVELOPMENT CENTER AMERICAS INC
Aug 2022
ACTIVE
High-throughput screening for antihypertensive prescribing cascades
Role: Co-Investigator
Funding: NATL INST OF HLTH NHLBI
Aug 2022
ACTIVE
GSK-UF Fellowship Year 2 (2022 -2023)
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
May 2022
ACTIVE
Development of a biopharmaceutics roadmap for integrating in vitro data with gastrointestinal physiology in PBPK models
Role: Co-Project Director/Principal Investigator
Funding: F HOFFMANN LA ROCHE
Sep 2021
ACTIVE
Optimizing Muscular Dystrophy Clinical Trial Designs using Modeling and Simulation
Role: Co-Investigator
Funding: NATL INST OF HLTH NCATS
Sep 2021
– Jun 2022
CLINICAL PHARMACOKINETICS/DYNAMICS FELLOWSHIP PROGRAM FUNDING AGREEMENT YEAR 2
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
Aug 2021
– Jan 2022
Development of a physiologically based pharmacokinetic model for levetiracetam to evaluate brain tissue distribution of different drug products
Role: Co-Investigator
Funding: LABORATORIOS LESVI
Aug 2021
– Jul 2022
GSK-UF Fellowship Year 1 (2021 -2022)
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
Jul 2021
– Dec 2022
Novel physiologically based absorption modeling to predict the pharmacokinetic of nasal formulations in adults and pediatrics
Role: Co-Investigator
Funding: SIMULATIONS PLUS
Apr 2021
ACTIVE
Takeda Research Agreement – Rogge Contract
Role: Principal Investigator
Funding: TAKEDA PHARM NORTH AMERICA
Apr 2021
– Sep 2022
Using Physiologically-Based Pharmacokinetic (PBPK) Simulation Approaches to Evaluate Drug-Drug-Interactions (DDIs)
Role: Principal Investigator
Funding: SIMULATIONS PLUS
Sep 2020
– Aug 2021
CLINICAL PHARMACOKINETICS/DYNAMICS FELLOWSHIP – YEAR 1
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
Jul 2020
– Oct 2021
GSK Postdoctoral Fellowship
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
Jun 2020
– Dec 2022
Development of a Physiologically based Pharmacokinetic Model (PBPK) to Inform the Development of a New Nasal Formulation of Epinephrine
Role: Co-Investigator
Funding: ARS PHARMACEUTICALS
Aug 2019
– Aug 2020
Pharmacometrics Modeling and Simulation of Probe Drugs Profiles Subjected to Competitive Enzyme Inhibition under Various Drug Administration Conditions
Role: Principal Investigator
Funding: TABULA RASA HEALTHCARE
Jul 2019
– Jun 2020
Microdialysis study of Lipo680 in the animal model
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
via BIOMEDICAL ADVANCED RES & DEVLPMT AUTHOR
Jul 2019
– Jul 2019
Clinical Pharmacokinetics/Dynamics Fellowship 2019-2020 – Mohammad Akbar
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
Nov 2018
– Aug 2021
Development of a Mechanism-Based Drug Disease Trial Model for Parkinsons disease (PD)
Role: Co-Investigator
Funding: MILLENNIUM PHARMACEUTICAL
Aug 2018
ACTIVE
Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
Role: Co-Investigator
Funding: NATL INST OF HLTH NICHD
Jul 2018
– Jun 2019
Microdialysis study of Lipo680 in the animal model
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
via BIOMEDICAL ADVANCED RES & DEVLPMT AUTHOR
Jul 2018
– Jul 2020
Development and qualification of an expanded Diabetes model
Role: Principal Investigator
Funding: ELI LILLY AND CO
Jul 2018
– Jun 2019
Clinical Pharmacokinetics/Dynamics Fellowship 2018-2019
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
Jul 2018
– Apr 2019
Clinical Pharmacokinetics/Dynamics Fellowship 2018-2019 – Mohammad Akbar
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
Nov 2017
ACTIVE
Application of physiologically-based pharmacokinetic models to inform dosing recommendations for hormonal contraceptives co-administered with other medications
Role: Principal Investigator
Funding: GATES FOU, BILL & MELINDA
Jan 2017
– Jan 2019
Improved pediatric dose selection through physiologically based pharmacokinetic modeling
Role: Principal Investigator
Funding: F HOFFMANN LA ROCHE
Aug 2016
– Jul 2022
Optimizing combination therapy for accelerate clinical cure of tuberculosis
Role: Co-Investigator
Funding: NATL INST OF HLTH NIAID
Jul 2016
– Dec 2018
Clinical Pharmacokinetic/Dynamics Fellowship
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
Nov 2015
– Aug 2017
Research Fellowship Program for Pharmacokinetics
Role: Principal Investigator
Funding: GLAXO SMITHKLINE
Oct 2015
– Oct 2018
Translational Research Institute for Metabolism and Diabetes Post Doctoral Consortium Agreement
Role: Principal Investigator
Funding: TRANSLATIONAL RES INST METABOLISM & DIAB
Aug 2015
– Aug 2016
Pediatric PBPK model for large molecules in PK-Sim
Role: Principal Investigator
Funding: BAYER TECHNOLOGY SERVICES
Apr 2015
– Feb 2017
In Silico Clinical Trial Qualification of Successful Biomarker Measurements Related to Momoclonal Antibody Drug Therapy
Role: Principal Investigator
Funding: JANSSEN RESEARCH AND DEVELOPMENT
Apr 2015
– Oct 2017
Systems Pharmacology Based Modeling as a Platform for Safety Assessment of Contractility Endpoints of Potential Inotropes
Role: Principal Investigator
Funding: ASTRAZENECA
Sep 2014
– Feb 2019
Pharmacokinetic and Pharmacodynamic (PK-PD) Studies of Cardiovascular Drugs
Role: Project Manager
Funding: US FOOD AND DRUG ADMN
Sep 2014
– Aug 2018
A Model- and Systems-based Approach to Efficacy and Safety Questions Related to Generic Substitution
Role: Principal Investigator
Funding: US FOOD AND DRUG ADMN
Apr 2013
– Dec 2016
In Silico Modeling of Biomarkers and Surrogate Endpoints of Diabetes
Role: Principal Investigator
Funding: ELI LILLY AND CO
Jul 2007
– Aug 2016
Clinical and Translational Science Institute
Role: Project Manager
Funding: UF RESEARCH FOU
Education
Ph.D.
2008
·
University of Florida
B.S.
2004
·
Friedrich-Alexander University
Contact Details
Phones:
- Business:
- (407) 313-7012
Emails:
- Business:
- sschmidt@cop.ufl.edu
Addresses:
- Business Mailing:
-
6550 SANGER RD OFC 467
ORLANDO FL 32827 - Business Street:
-
6550 SANGER RD OFC 467
ORLANDO FL 32827