Rodrigo Cristofoletti

Rodrigo Cristofoletti, Ph.D.

Assistant Professor

Department: Pharmaceutics
Business Phone: (407) 313-7050
Business Email: rcristofoletti@cop.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 Therapeutic Equivalence Department of the Brazilian Drug Regulatory Agency (ANVISA) has been Dr. Cristofoletti’s place of employment for the last 14 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 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.

Research Profile

Dr. Cristofoletti’s research focuses on leveraging quantitative methods and modeling to optimize drug development and modernize regulatory review processes. A major emphasis has been on integrating in vitro-in vivo extrapolation with physiologically-based and PK/PD models to address interpatient variability in drug absorption and pharmacological response. He is also interested in investigating the kinetics of target site drug distributions in disease states under the overarching umbrella of quantitative systems pharmacology. Dr. Cristofoletti published more than 35 peer-reviewed articles in highly respected journals in the pharmaceutics field as well as 5 book chapters.

Publications

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. 12(6) [DOI] 10.3390/pharmaceutics12060566. [PMID] 32570975.
2020
Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products.
The AAPS journal. 22(5) [DOI] 10.1208/s12248-020-00495-4. [PMID] 32830289.
2020
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.
2020
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.
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. 12(11) [DOI] 10.3390/pharmaceutics12111049. [PMID] 33147873.
2020
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.
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. 86(11):2247-2255 [DOI] 10.1111/bcp.14326. [PMID] 32335930.
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. 12(12) [DOI] 10.3390/pharmaceutics12121137. [PMID] 33255861.
2020
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate.
Journal of pharmaceutical sciences. 109(6):1846-1862 [DOI] 10.1016/j.xphs.2020.03.025. [PMID] 32240696.
2020
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride.
Journal of pharmaceutical sciences. 109(9):2654-2675 [DOI] 10.1016/j.xphs.2020.06.007. [PMID] 32534881.
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. 143 [DOI] 10.1016/j.ejps.2019.105170. [PMID] 31783158.
2019
Application of the relationship between pharmacokinetics and pharmacodynamics in drug development and therapeutic equivalence: a PEARRL review.
The Journal of pharmacy and pharmacology. 71(4):699-723 [DOI] 10.1111/jphp.13070. [PMID] 30793317.
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
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. 8(4):197-200 [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. 108(12):3842-3847 [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. 8(6):352-355 [DOI] 10.1002/psp4.12425. [PMID] 31179639.
2019
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron.
Journal of pharmaceutical sciences. 108(10):3157-3168 [DOI] 10.1016/j.xphs.2019.05.033. [PMID] 31181225.
2018
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Proguanil Hydrochloride.
Journal of pharmaceutical sciences. 107(7):1761-1772 [DOI] 10.1016/j.xphs.2018.03.009. [PMID] 29571740.
2018
Non-Procrustean pathways for complex generic drugs development.
Therapeutic delivery. 9(9):605-607 [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. 107(10):2519-2530 [DOI] 10.1016/j.xphs.2018.06.013. [PMID] 29935299.
2017
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Enalapril.
Journal of pharmaceutical sciences. 106(8):1933-1943 [DOI] 10.1016/j.xphs.2017.04.019. [PMID] 28435140.
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. 106(2):560-569 [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. 106(10):2930-2945 [DOI] 10.1016/j.xphs.2017.04.068. [PMID] 28483422.
2017
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.
Journal of pharmaceutical sciences. 106(12):3421-3430 [DOI] 10.1016/j.xphs.2017.08.007. [PMID] 28842299.
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. 43(4):668-677 [DOI] 10.1080/03639045.2016.1278013. [PMID] 28032517.
2017
Dissolution Methods to Increasing Discriminatory Power of In Vitro Dissolution Testing for Ibuprofen Free Acid and Its Salts.
Journal of pharmaceutical sciences. 106(1):92-99 [DOI] 10.1016/j.xphs.2016.06.001. [PMID] 27397434.
2016
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin.
Journal of pharmaceutical sciences. 105(4):1362-9 [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. 105(12):3658-3667 [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. 105(9):2712-2722 [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. 105(9):2794-2803 [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. 105:134-40 [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. 103:104-108 [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. 104(9):2676-87 [DOI] 10.1002/jps.24350. [PMID] 25663270.
2015
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Nifedipine.
Journal of pharmaceutical sciences. 104(10):3289-98 [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. 67(8):1156-69 [DOI] 10.1111/jphp.12411. [PMID] 25828546.
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. 103(10):3263-75 [DOI] 10.1002/jps.24076. [PMID] 25043938.
2014
Similarities and differences of international guidelines for bioequivalence: an update of the Brazilian requirements.
The AAPS journal. 16(2):350-1 [DOI] 10.1208/s12248-014-9570-2. [PMID] 24493374.
2014
Significance of metabolites in bioequivalence: losartan potassium as a case study.
Journal of pharmaceutical sciences. 103(6):1584-91 [DOI] 10.1002/jps.23965. [PMID] 24700383.
2014
Biowaiver monograph for immediate-release solid oral dosage forms: fluconazole.
Journal of pharmaceutical sciences. 103(12):3843-3858 [DOI] 10.1002/jps.24181. [PMID] 25312492.
2014
Biowaiver monograph for immediate-release solid oral dosage forms: bisoprolol fumarate.
Journal of pharmaceutical sciences. 103(2):378-91 [DOI] 10.1002/jps.23817. [PMID] 24382794.
2014
Biowaiver monographs for immediate-release solid oral dosage forms: codeine phosphate.
Journal of pharmaceutical sciences. 103(6):1592-600 [DOI] 10.1002/jps.23977. [PMID] 24788239.
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. 102(9):3136-44 [DOI] 10.1002/jps.23515. [PMID] 23580377.
2013
Biowaiver monographs for immediate release solid oral dosage forms: efavirenz.
Journal of pharmaceutical sciences. 102(2):318-29 [DOI] 10.1002/jps.23380. [PMID] 23175470.
2012
Biowaiver monographs for immediate-release solid oral dosage forms: stavudine.
Journal of pharmaceutical sciences. 101(1):10-6 [DOI] 10.1002/jps.22756. [PMID] 21922462.
2011
Biowaiver monographs for immediate release solid oral dosage forms: levofloxacin.
Journal of pharmaceutical sciences. 100(5):1628-36 [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. 25(6):670-81 [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. 288(3):R671-7 [PMID] 15539607.
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Grants

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

Education

Ph.D.
2017 · Johann Wolfgang Goethe University

Teaching Profile

Courses Taught
2020-2021
PHA7979 Advanced Research
2021
PHA6131 Pharmacometrics and Systems Pharmacology

Contact Details

Phones:
Business:
(407) 313-7050
Emails: