Valvanera Vozmediano Esteban

Valvanera Vozmediano Esteban, Ph.D.

Assistant Professor

Department: Pharmaceutics
Business Phone: (407) 313-7052
Business Email: valva@cop.ufl.edu

About Valvanera Vozmediano Esteban

Valvanera Vozmediano, Ph.D., is an assistant professor at the Center of Pharmacometrics & System Pharmacology at University of Florida College of Pharmacy. She has been working as Principal Consultant with Dynakin’s Drug Modeling & Consulting group, and has been the Director of the Research & Development Department of the same company since 2008.

She received her B.S. in pharmacy from the University of Basque Country in Spain in 2006, and earned her Ph.D. in Pharmacology in 2011 at the same university. Her doctorate research was completed at Dynakin with the design of pioneering regulatory standard pediatric investigational plan (PIP) for a new H1 antihistamine drug applying state of the art modeling & simulation (M&S) techniques. Her research activity includes a postdoctoral internship as Marie Curie (B-MOB program) and authorship of peer-reviewed publications. Valvanera is expert in the application of allometric scaling and preclinical MBDD using population PK/PD methods specializing in translational development, mainly for the pediatric field. She has successfully completed several projects in that domain as an industrial consultant in FTIM questions, PIPs, and bridging studies, including support to successful filings for new drug applications. Valvanera is an invited professor for the Master in Drug Development of the University of Basque Country, and she is also a tutor in the International Master of Pediatric Clinical Pharmacology from the Global Research in Pediatric Network of Excellence, or GRIP.

Research Profile

Research interests include:

Model Informed Drug Development for strategic decision making in Special Populations including pediatrics, geriatrics, different ethnicities & rare diseases

Implementation of Pharmacometric Based Regulatory Strategies

Application of Translational Research to Animal Health

Publications

2021
Application of a dual mechanistic approach to support bilastine dose selection for older adults.
CPT: pharmacometrics & systems pharmacology. [DOI] 10.1002/psp4.12671. [PMID] 34157202.
2021
In Vitro Synergistic Interactions of Isavuconazole and Echinocandins against Candida auris.
Antibiotics (Basel, Switzerland). 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
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.
2020
Incorporating Pharmacometrics into Pharmacoeconomic Models: Applications from Drug Development.
PharmacoEconomics. 38(10):1031-1042 [DOI] 10.1007/s40273-020-00944-0. [PMID] 32734572.
2020
Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria.
European journal of pediatrics. 179(5):801-805 [DOI] 10.1007/s00431-019-03559-6. [PMID] 31919579.
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
Vancomycin in peritoneal dialysis: Clinical pharmacology considerations in therapy.
Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis. 40(4):384-393 [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
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
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
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
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
Population Pharmacokinetic Modeling of Acetaminophen Protein Adducts in Adults and Children.
Journal of clinical pharmacology. [DOI] 10.1002/jcph.1555. [PMID] 31802503.
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.
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
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.
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
Model Informed Pediatric Development Applied to Bilastine: Ontogenic PK Model Development, Dose Selection for First Time in Children and PK Study Design.
Pharmaceutical research. 34(12):2720-2734 [DOI] 10.1007/s11095-017-2248-6. [PMID] 28971281.
2014
Evaluation of fentanyl disposition and effects in newborn piglets as an experimental model for human neonates.
PloS one. 9(3) [DOI] 10.1371/journal.pone.0090728. [PMID] 24595018.
2014
Integration of preclinical and clinical knowledge to predict intravenous PK in human: bilastine case study.
European journal of drug metabolism and pharmacokinetics. 39(1):33-41 [DOI] 10.1007/s13318-013-0131-3. [PMID] 23619917.
2013
A predictive pharmacokinetic/pharmacodynamic model of fentanyl for analgesia/sedation in neonates based on a semi-physiologic approach.
Paediatric drugs. 15(3):247-57 [DOI] 10.1007/s40272-013-0029-1. [PMID] 23657896.

Grants

Jul 2021 ACTIVE
Novel physiologically based absorption modeling to predict the pharmacokinetic of nasal formulations in adults and pediatrics
Role: Principal Investigator
Funding: SIMULATIONS PLUS
Jun 2020 – Sep 2021
Development of a Physiologically based Pharmacokinetic Model (PBPK) to Inform the Development of a New Nasal Formulation of Epinephrine
Role: Principal Investigator
Funding: ARS PHARMACEUTICALS
Nov 2018 – Aug 2021
Development of a Mechanism-Based Drug Disease Trial Model for Parkinsons disease (PD)
Role: Principal Investigator
Funding: MILLENNIUM PHARMACEUTICAL
Nov 2017 ACTIVE
Application of physiologically-based pharmacokinetic models to inform dosing recommendations for hormonal contraceptives co-administered with other medications
Role: Co-Investigator
Funding: GATES FOU, BILL & MELINDA

Education

Ph.D.
2011 · University of Basque Country
B.S.
2006 · University of Basque Country

Teaching Profile

Courses Taught
2019-2021
PHA7979 Advanced Research
2018,2020
PHA6935 Selected Topics in Pharmacy
2020
PHA6910 Supervised Research
2018,2020-2021
PHA6125 Introduction to Quantitative Pharmacology
2019-2020
PHA7980 Research for Doctoral Dissertation
2020-2021
PHA6971 Research for Master’s Thesis
2018-2019,2021
PHA5132 Prin Drug Ther Indiv
2018
PHA5787C Pt Care 5: Endo

Contact Details

Phones:
Business:
(407) 313-7052
Emails:
Business:
valva@cop.ufl.edu