Rodrigo Cristofoletti

Rodrigo Cristofoletti, Ph.D.

Assistant Professor

Department: Pharmaceutics
Business Phone: (407) 313-7050
Business Email: rcristofoletti@ufl.edu

About Rodrigo Cristofoletti

Rodrigo Cristofoletti, Ph.D., joined the University of Florida in 2019 as research assistant professor in the Center for Pharmacometrics and Systems Pharmacology (Orlando) in the Department of Pharmaceutics. He received his B.S. in Pharmaceutical Sciences from the University of Sao Paulo, Brazil in 2004. Dr. Cristofoletti received his Ph.D. summa cum laude from the Johann Wolfgang Goethe University (Frankfurt am Main, Germany) under the supervision of Dr. Jennifer Dressman in 2017. The Clinical Pharmacology & Biopharmaceutics Office of the Brazilian Drug Regulatory Agency (ANVISA) has been Dr. Cristofoletti’s place of employment for the last 15 years. While there, his research on oral drug absorption has helped in building scientific foundations for generic policies within Brazilian jurisdiction.

Dr. Cristofoletti received the Simcyp Academic Most Informative and Scientific Report 2017 and 2020 Award for his research on translational modeling strategies to establishing an in vitro-in vivo link. He serves as a member of the Special Interest Group on BCS and Biowaiver of the International Pharmaceutical Federation (FIP) and a member of the Brazilian Pharmacopoeia.

Teaching Profile

Courses Taught
2020-2023
PHA7979 Advanced Research
2021
PHA6131 Pharmacometrics and Systems Pharmacology
2021-2023
PHA5789C Patient Care 7
2021
PHA6125 Introduction to Quantitative Pharmacology
2022
PHA7980 Research for Doctoral Dissertation

Research Profile

Dr. Cristofoletti’s research focuses on integrating in vitro systems and quantitative methods and modeling to inform drug discovery and drug product development with focus on: a) Mechanistic absorption models for IVIVC, IVIVE and virtual bioequivalence trials; b) Metabolic- and transport-mediated drug-drug interaction and c) Disease-based models. Dr. Cristofoletti’s lab has been applying stem cell technology, co-culture techniques and microfluidics to develop microphysiological systems to investigate drug- and disease-related mechanisms affecting membrane integrity and predict drug absorption/tissue disposition. A major emphasis has been on developing a segment-specific intestine-on-a-chip to investigate drug- and disease-related mechanism affecting intestinal membrane integrity (leaky gut) as well as transport-mediated kinetics and drug-drug interactions. He is also interested in applying organ-on-a-chip technology to study drug penetration in brain parenchyma and cerebrospinal fluid. Dr. Cristofoletti published more than 50 peer-reviewed articles in highly respected journals in the pharmaceutics field as well as 5 book chapters.

Open Researcher and Contributor ID (ORCID)

0000-0003-2619-0343

Publications

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. [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. [DOI] 10.1002/cpt.2457. [PMID] 34674227.
2022
Development of a Translational Exposure‐Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products
Clinical Pharmacology & Therapeutics. [DOI] 10.1002/cpt.2690.
2022
Jennifer Dressman – 40 years of Oral Drug Absorption.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2021.10.020. [PMID] 34699841.
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. [DOI] 10.1002/jcph.1951. [PMID] 34383318.
2022
Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling.
The AAPS journal. [DOI] 10.1208/s12248-021-00672-z. [PMID] 34988679.
2021
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2021.02.019. [PMID] 33610571.
2021
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metformin Hydrochloride.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2021.01.011. [PMID] 33450218.
2021
Model-Informed Optimization of a Pediatric Clinical Pharmacokinetic Trial of a New Spironolactone Liquid Formulation.
Pharmaceutics. [DOI] 10.3390/pharmaceutics13060849. [PMID] 34201093.
2021
Navigating Through Cell-Based In vitro Models Available for Prediction of Intestinal Permeability and Metabolism: Are We Ready for 3D?
The AAPS journal. [DOI] 10.1208/s12248-021-00665-y. [PMID] 34811603.
2021
Pharmacokinetics of Benznidazole in Experimental Chronic Chagas Disease Using the Swiss Mouse-Berenice-78 Trypanosoma cruzi Strain Model.
Antimicrobial agents and chemotherapy. [DOI] 10.1128/AAC.01383-20. [PMID] 33168611.
2021
Physiologically-based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate.
CPT: pharmacometrics & systems pharmacology. [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. [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. [DOI] 10.1002/cpt.2087. [PMID] 33073366.
2021
Scientific considerations to move towards biowaiver for biopharmaceutical classification system class III drugs: How modeling and simulation can help.
Biopharmaceutics & drug disposition. [DOI] 10.1002/bdd.2274. [PMID] 33759204.
2020
Application of the Gastrointestinal Simulator (GIS) Coupled with In Silico Modeling to Measure the Impact of Coca-Cola® on the Luminal and Systemic Behavior of Loratadine (BCS Class 2b).
Pharmaceutics. [DOI] 10.3390/pharmaceutics12060566. [PMID] 32570975.
2020
Assessing the impact of cystic fibrosis on the antipyretic response of ibuprofen in children: Physiologically-based modeling as a candle in the dark.
British journal of clinical pharmacology. [DOI] 10.1111/bcp.14326. [PMID] 32335930.
2020
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2020.06.007. [PMID] 32534881.
2020
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2020.03.025. [PMID] 32240696.
2020
Erratum: Hens, B.; et al. Application of the Gastrointestinal Simulator (GIS) Coupled with In Silico Modeling to Measure the Impact of Coca-Cola® on the Luminal and Systemic Behavior of Loratadine (BCS Class 2b). Pharmaceutics, 2020, 12, 566.
Pharmaceutics. [DOI] 10.3390/pharmaceutics12121137. [PMID] 33255861.
2020
Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences. [DOI] 10.1016/j.ejps.2019.105170. [PMID] 31783158.
2020
Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Predict the Impact of CYP2C9 Genetic Polymorphisms, Co-Medication and Formulation on the Pharmacokinetics and Pharmacodynamics of Flurbiprofen.
Pharmaceutics. [DOI] 10.3390/pharmaceutics12111049. [PMID] 33147873.
2020
Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products.
The AAPS journal. [DOI] 10.1208/s12248-020-00495-4. [PMID] 32830289.
2019
Application of the relationship between pharmacokinetics and pharmacodynamics in drug development and therapeutic equivalence: a PEARRL review.
The Journal of pharmacy and pharmacology. [DOI] 10.1111/jphp.13070. [PMID] 30793317.
2019
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2019.05.033. [PMID] 31181225.
2019
Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended-Release Case Study.
Journal of clinical pharmacology. [DOI] 10.1002/jcph.1433. [PMID] 31087554.
2019
Iberoamerican Pharmacometrics Network Congress 2018 Report: Fostering Modeling and Simulation Approaches for Drug Development and Regulatory and Clinical Applications in Latin America.
CPT: pharmacometrics & systems pharmacology. [DOI] 10.1002/psp4.12387. [PMID] 30681295.
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. [DOI] 10.1016/j.xphs.2019.09.012. [PMID] 31539541.
2019
Pharmacometrics, Physiologically Based Pharmacokinetics, Quantitative Systems Pharmacology-What’s Next?-Joining Mechanistic and Epidemiological Approaches.
CPT: pharmacometrics & systems pharmacology. [DOI] 10.1002/psp4.12425. [PMID] 31179639.
2018
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Proguanil Hydrochloride.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2018.03.009. [PMID] 29571740.
2018
Non-Procrustean pathways for complex generic drugs development.
Therapeutic delivery. [DOI] 10.4155/tde-2018-0047. [PMID] 30189807.
2018
Past, Present, and Future of Bioequivalence: Improving Assessment and Extrapolation of Therapeutic Equivalence for Oral Drug Products.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2018.06.013. [PMID] 29935299.
2017
Assessment of Bioequivalence of Weak Base Formulations Under Various Dosing Conditions Using Physiologically Based Pharmacokinetic Simulations in Virtual Populations. Case Examples: Ketoconazole and Posaconazole.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2016.10.008. [PMID] 27865610.
2017
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2017.04.068. [PMID] 28483422.
2017
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Enalapril.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2017.04.019. [PMID] 28435140.
2017
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2017.08.007. [PMID] 28842299.
2017
Dissolution Methods to Increasing Discriminatory Power of In Vitro Dissolution Testing for Ibuprofen Free Acid and Its Salts.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2016.06.001. [PMID] 27397434.
2017
Integrating biopharmaceutics risk assessment and in vivo absorption model in formulation development of BCS class I drug using the QbD approach.
Drug development and industrial pharmacy. [DOI] 10.1080/03639045.2016.1278013. [PMID] 28032517.
2016
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2016.01.017. [PMID] 26952879.
2016
Bridging the Gap Between In Vitro Dissolution and the Time Course of Ibuprofen-Mediating Pain Relief.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2016.08.024. [PMID] 27751586.
2016
Differences in Food Effects for 2 Weak Bases With Similar BCS Drug-Related Properties: What Is Happening in the Intestinal Lumen?
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2015.11.033. [PMID] 26921120.
2016
Exploratory Investigation of the Limiting Steps of Oral Absorption of Fluconazole and Ketoconazole in Children Using an In Silico Pediatric Absorption Model.
Journal of pharmaceutical sciences. [DOI] 10.1016/j.xphs.2016.01.027. [PMID] 26987949.
2016
FaSSIF-V3, but not compendial media, appropriately detects differences in the peak and extent of exposure between reference and test formulations of ibuprofen.
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V. [DOI] 10.1016/j.ejpb.2016.06.004. [PMID] 27287554.
2016
Matching phosphate and maleate buffer systems for dissolution of weak acids: Equivalence in terms of buffer capacity of bulk solution or surface pH?
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V. [DOI] 10.1016/j.ejpb.2016.03.024. [PMID] 27032508.
2015
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levetiracetam.
Journal of pharmaceutical sciences. [DOI] 10.1002/jps.24350. [PMID] 25663270.
2015
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Nifedipine.
Journal of pharmaceutical sciences. [DOI] 10.1002/jps.24560. [PMID] 26149619.
2015
Risk assessment for extending the Biopharmaceutics Classification System-based biowaiver of immediate release dosage forms of fluconazole in adults to the paediatric population.
The Journal of pharmacy and pharmacology. [DOI] 10.1111/jphp.12411. [PMID] 25828546.
2014
Biowaiver monograph for immediate-release solid oral dosage forms: bisoprolol fumarate.
Journal of pharmaceutical sciences. [DOI] 10.1002/jps.23817. [PMID] 24382794.
2014
Biowaiver monograph for immediate-release solid oral dosage forms: fluconazole.
Journal of pharmaceutical sciences. [DOI] 10.1002/jps.24181. [PMID] 25312492.
2014
Biowaiver monographs for immediate-release solid oral dosage forms: codeine phosphate.
Journal of pharmaceutical sciences. [DOI] 10.1002/jps.23977. [PMID] 24788239.
2014
Significance of metabolites in bioequivalence: losartan potassium as a case study.
Journal of pharmaceutical sciences. [DOI] 10.1002/jps.23965. [PMID] 24700383.
2014
Similarities and differences of international guidelines for bioequivalence: an update of the Brazilian requirements.
The AAPS journal. [DOI] 10.1208/s12248-014-9570-2. [PMID] 24493374.
2014
Use of physiologically based pharmacokinetic models coupled with pharmacodynamic models to assess the clinical relevance of current bioequivalence criteria for generic drug products containing Ibuprofen.
Journal of pharmaceutical sciences. [DOI] 10.1002/jps.24076. [PMID] 25043938.
2013
A comparative analysis of biopharmaceutics classification system and biopharmaceutics drug disposition classification system: a cross-sectional survey with 500 bioequivalence studies.
Journal of pharmaceutical sciences. [DOI] 10.1002/jps.23515. [PMID] 23580377.
2013
Biowaiver monographs for immediate release solid oral dosage forms: efavirenz.
Journal of pharmaceutical sciences. [DOI] 10.1002/jps.23380. [PMID] 23175470.
2012
Biowaiver monographs for immediate-release solid oral dosage forms: stavudine.
Journal of pharmaceutical sciences. [DOI] 10.1002/jps.22756. [PMID] 21922462.
2011
Biowaiver monographs for immediate release solid oral dosage forms: levofloxacin.
Journal of pharmaceutical sciences. [DOI] 10.1002/jps.22413. [PMID] 21374601.
2011
Cyclooxygenase-independent mechanism of ibuprofen-induced antipyresis: the role of central vasopressin V₁ receptors.
Fundamental & clinical pharmacology. [DOI] 10.1111/j.1472-8206.2010.00894.x. [PMID] 21077948.
2005
The effects of selective and nonselective cyclooxygenase inhibitors on endothelin-1-induced fever in rats.
American journal of physiology. Regulatory, integrative and comparative physiology. [PMID] 15539607.

Grants

May 2022 ACTIVE
Development of a biopharmaceutics roadmap for integrating in vitro data with gastrointestinal physiology in PBPK models
Role: Principal Investigator
Funding: F HOFFMANN LA ROCHE
Aug 2021 ACTIVE
Development and validation of a best practices framework for PBPK analysis for biopharmaceutic applications in support of model-informed biowaivers of fed state BE studies for BCS class II drugs
Role: Principal Investigator
Funding: US FOOD AND DRUG ADMN
Apr 2021 ACTIVE
Using Physiologically-Based Pharmacokinetic (PBPK) Simulation Approaches to Evaluate Drug-Drug-Interactions (DDIs)
Role: Co-Project Director/Principal Investigator
Funding: SIMULATIONS PLUS
Nov 2020 ACTIVE
Integrating Dissolution and Translational Modeling Strategies to Establish In Vitro-In Vivo Links
Role: Principal Investigator
Funding: LIBBS FARMACEUTICA
Jun 2020 ACTIVE
Assessing the impact of highly prevalent chronic comorbidities on antifungal treatment in elderly patients: disease-based modeling as a candle in the dark
Role: Principal Investigator
Funding: SIMULATIONS PLUS
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

Contact Details

Phones:
Business:
(407) 313-7050
Emails:
Addresses:
Business Mailing:
6550 SANGER RD
ORLANDO FL 32827
Business Street:
6550 Sanger Rd
Orlando FL 32827