Rodrigo Cristofoletti

Center for Pharmacometrics & Systems Pharmacology, University of Florida

Research Area

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JoVE Journal Publications

ArticleTotal : 1	Year
Publication title Cited by 6	2024

Other Publications

Article	Year
Past, Present, and Future of Bioequivalence: Improving Assessment and Extrapolation of Therapeutic Equivalence for Oral Drug Products. Journal of pharmaceutical sciences\| PubMed ID: 29935299	2018
Non-Procrustean pathways for complex generic drugs development. Therapeutic delivery\| PubMed ID: 30189807	2018
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\| PubMed ID: 30681295	2019
Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended-Release Case Study. Journal of clinical pharmacology\| PubMed ID: 31087554	2019
Pharmacometrics, Physiologically Based Pharmacokinetics, Quantitative Systems Pharmacology-What's Next?-Joining Mechanistic and Epidemiological Approaches. CPT: pharmacometrics & systems pharmacology\| PubMed ID: 31179639	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\| PubMed ID: 31539541	2019
Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case ... European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences\| PubMed ID: 31783158	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\| PubMed ID: 32335930	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\| PubMed ID: 32570975	2020
Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products. The AAPS journal\| PubMed ID: 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\| PubMed ID: 33073366	2021
Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Predict the Impact of CYP2C9 Genetic Polymorphisms, Co-Medication and Formulation on the Pharmacokinetics and Pharmacodynami... Pharmaceutics\| PubMed ID: 33147873	2020
Pharmacokinetics of Benznidazole in Experimental Chronic Chagas Disease Using the Swiss Mouse-Berenice-78 Trypanosoma cruzi Strain Model. Antimicrobial agents and chemotherapy\| PubMed ID: 33168611	2021
Quantitative Assessment of Levonorgestrel Binding Partner Interplay and Drug-Drug Interactions Using Physiologically Based Pharmacokinetic Modeling. CPT: pharmacometrics & systems pharmacology\| PubMed ID: 33217171	2021
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 Lorat... Pharmaceutics\| PubMed ID: 33255861	2020
Physiologically-based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate. CPT: pharmacometrics & systems pharmacology\| PubMed ID: 33449439	2021
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine. Journal of pharmaceutical sciences\| PubMed ID: 33610571	2021
Scientific considerations to move towards biowaiver for biopharmaceutical classification system class III drugs: How modeling and simulation can help. Biopharmaceutics & drug disposition\| PubMed ID: 33759204	2021
Model-Informed Optimization of a Pediatric Clinical Pharmacokinetic Trial of a New Spironolactone Liquid Formulation. Pharmaceutics\| PubMed ID: 34201093	2021
Physiologically Based Pharmacokinetic Modeling to Assess the Impact of CYP2D6-Mediated Drug-Drug Interactions on Tramadol and O-Desmethyltramadol Exposures via Allosteric and Competitive Inh... Journal of clinical pharmacology\| PubMed ID: 34383318	2022
Determining the Exposure Threshold for Levonorgestrel Efficacy Using an Integrated Model Based Meta-Analysis Approach. Clinical pharmacology and therapeutics\| PubMed ID: 34674227	2022
Jennifer Dressman - 40 years of Oral Drug Absorption. Journal of pharmaceutical sciences\| PubMed ID: 34699841	2022
Navigating Through Cell-Based In vitro Models Available for Prediction of Intestinal Permeability and Metabolism: Are We Ready for 3D? The AAPS journal\| PubMed ID: 34811603	2021
Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologicall... The AAPS journal\| PubMed ID: 34988679	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\| PubMed ID: 35598768	2022
Development of a Translational Exposure-Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products. Clinical pharmacology and therapeutics\| PubMed ID: 35723889	2022
Regulatory utility of physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report. CPT: pharmacometrics & systems pharmacology\| PubMed ID: 36530026	2023
Biowaiver Monograph for Immediate-Release Dosage Forms: Levamisole Hydrochloride. Journal of pharmaceutical sciences\| PubMed ID: 36563854	2023
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride. Journal of pharmaceutical sciences\| PubMed ID: 36581104	2023
Real-world effect of a potential drug-drug interaction between topiramate and oral contraceptives on unintended pregnancy outcomes. Contraception\| PubMed ID: 36641095	2023
Integrating Forward and Reverse Translation in PBPK Modeling to Predict Food Effect on Oral Absorption of Weakly Basic Drugs. Pharmaceutical research\| PubMed ID: 36788156	2023
Leveraging Physiologically Based Modelling to Provide Insights on the Absorption of Paliperidone Extended-Release Formulation under Fed and Fasting Conditions. Pharmaceutics\| PubMed ID: 36839950	2023
Effect of Roux-En-Y Gastric Bypass in the Pharmacokinetics of (R)-Carvedilol and (S)-Carvedilol. Journal of clinical pharmacology\| PubMed ID: 36854819	2023
Exploring in vitro solubility of lamotrigine in physiologically mimetic conditions to prospect the in vivo dissolution in pediatric population. Biopharmaceutics & drug disposition\| PubMed ID: 36951570	2023
Editorial: Insights in drug metabolism and transport: 2021. Frontiers in pharmacology\| PubMed ID: 37229271	2023
Model-Based Analysis of In Vivo Release Data of Levonorgestrel Implants: Projecting Long-Term Systemic Exposure. Pharmaceutics\| PubMed ID: 37242635	2023
Requirements, expectations, challenges and opportunities associated with training the next generation of pharmacometricians. CPT: pharmacometrics & systems pharmacology\| PubMed ID: 37452453	2023
A robust, viable, and resource sparing HPLC-based logP method applied to common drugs. International journal of pharmaceutics\| PubMed ID: 37591472	2023
Linking in vitro-in vivo extrapolations with physiologically based modeling to inform drug and formulation development. Biopharmaceutics & drug disposition\| PubMed ID: 37622923	2023
Challenges in Permeability Assessment for Oral Drug Product Development. Pharmaceutics\| PubMed ID: 37896157	2023
Comprehensive Physiologically Based Pharmacokinetic Model to Assess Drug-Drug Interactions of Phenytoin. Pharmaceutics\| PubMed ID: 37896246	2023
Adult and pediatric physiologically-based biopharmaceutics modeling to explain lamotrigine immediate release absorption process. CPT: pharmacometrics & systems pharmacology\| PubMed ID: 37916262	2024
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Isavuconazonium Sulfate. Journal of pharmaceutical sciences\| PubMed ID: 37951471	2024
Exploring the impact of CYP2D6 and UGT2B7 gene-drug interactions, and CYP-mediated DDI on oxycodone and oxymorphone pharmacokinetics using physiologically-based pharmacokinetic modeling and ... European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences\| PubMed ID: 38171419	2024