Rodrigo Cristofoletti Center for Pharmacometrics & Systems Pharmacology, Department of Pharmaceutics University of Florida Biography Publications Institution JoVE Articles Rodrigo Cristofoletti has not added a biography. If you are Rodrigo Cristofoletti and would like to personalize this page please email our Author Liaison for assistance. Publications 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 Simulation European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences. Mar, 2024 | Pubmed ID: 38171419 Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Isavuconazonium Sulfate Journal of Pharmaceutical Sciences. Feb, 2024 | Pubmed ID: 37951471 Adult and Pediatric Physiologically-based Biopharmaceutics Modeling to Explain Lamotrigine Immediate Release Absorption Process CPT: Pharmacometrics & Systems Pharmacology. Feb, 2024 | Pubmed ID: 37916262 Comprehensive Physiologically Based Pharmacokinetic Model to Assess Drug-Drug Interactions of Phenytoin Pharmaceutics. Oct, 2023 | Pubmed ID: 37896246 Challenges in Permeability Assessment for Oral Drug Product Development Pharmaceutics. Sep, 2023 | Pubmed ID: 37896157 Linking in Vitro-in Vivo Extrapolations with Physiologically Based Modeling to Inform Drug and Formulation Development Biopharmaceutics & Drug Disposition. Aug, 2023 | Pubmed ID: 37622923 A Robust, Viable, and Resource Sparing HPLC-based LogP Method Applied to Common Drugs International Journal of Pharmaceutics. Sep, 2023 | Pubmed ID: 37591472 Requirements, Expectations, Challenges and Opportunities Associated with Training the Next Generation of Pharmacometricians CPT: Pharmacometrics & Systems Pharmacology. Jul, 2023 | Pubmed ID: 37452453 Model-Based Analysis of In Vivo Release Data of Levonorgestrel Implants: Projecting Long-Term Systemic Exposure Pharmaceutics. May, 2023 | Pubmed ID: 37242635 Editorial: Insights in Drug Metabolism and Transport: 2021 Frontiers in Pharmacology. 2023 | Pubmed ID: 37229271 Exploring in Vitro Solubility of Lamotrigine in Physiologically Mimetic Conditions to Prospect the in Vivo Dissolution in Pediatric Population Biopharmaceutics & Drug Disposition. Apr, 2023 | Pubmed ID: 36951570 Effect of Roux-En-Y Gastric Bypass in the Pharmacokinetics of (R)-Carvedilol and (S)-Carvedilol Journal of Clinical Pharmacology. Jul, 2023 | Pubmed ID: 36854819 Leveraging Physiologically Based Modelling to Provide Insights on the Absorption of Paliperidone Extended-Release Formulation Under Fed and Fasting Conditions Pharmaceutics. Feb, 2023 | Pubmed ID: 36839950 Integrating Forward and Reverse Translation in PBPK Modeling to Predict Food Effect on Oral Absorption of Weakly Basic Drugs Pharmaceutical Research. Feb, 2023 | Pubmed ID: 36788156 Real-world Effect of a Potential Drug-drug Interaction Between Topiramate and Oral Contraceptives on Unintended Pregnancy Outcomes Contraception. Apr, 2023 | Pubmed ID: 36641095 Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride Journal of Pharmaceutical Sciences. Apr, 2023 | Pubmed ID: 36581104 Biowaiver Monograph for Immediate-Release Dosage Forms: Levamisole Hydrochloride Journal of Pharmaceutical Sciences. Mar, 2023 | Pubmed ID: 36563854 Regulatory Utility of Physiologically-based Pharmacokinetic Modeling to Support Alternative Bioequivalence Approaches and Risk Assessment: A Workshop Summary Report CPT: Pharmacometrics & Systems Pharmacology. May, 2023 | Pubmed ID: 36530026 Development of a Translational Exposure-Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products Clinical Pharmacology and Therapeutics. Oct, 2022 | Pubmed ID: 35723889 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. Jul, 2022 | Pubmed ID: 35598768 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. Jan, 2022 | Pubmed ID: 34988679 Jennifer Dressman - 40 Years of Oral Drug Absorption Journal of Pharmaceutical Sciences. Jan, 2022 | Pubmed ID: 34699841 Determining the Exposure Threshold for Levonorgestrel Efficacy Using an Integrated Model Based Meta-Analysis Approach Clinical Pharmacology and Therapeutics. Feb, 2022 | Pubmed ID: 34674227 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. Jan, 2022 | Pubmed ID: 34383318 Navigating Through Cell-Based In Vitro Models Available for Prediction of Intestinal Permeability and Metabolism: Are We Ready for 3D? The AAPS Journal. Nov, 2021 | Pubmed ID: 34811603 Model-Informed Optimization of a Pediatric Clinical Pharmacokinetic Trial of a New Spironolactone Liquid Formulation Pharmaceutics. Jun, 2021 | Pubmed ID: 34201093 Scientific Considerations to Move Towards Biowaiver for Biopharmaceutical Classification System Class III Drugs: How Modeling and Simulation Can Help Biopharmaceutics & Drug Disposition. Apr, 2021 | Pubmed ID: 33759204 Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine Journal of Pharmaceutical Sciences. May, 2021 | Pubmed ID: 33610571 Physiologically-based Pharmacokinetics Modeling to Investigate Formulation Factors Influencing the Generic Substitution of Dabigatran Etexilate CPT: Pharmacometrics & Systems Pharmacology. Mar, 2021 | Pubmed ID: 33449439 Quantitative Assessment of Levonorgestrel Binding Partner Interplay and Drug-Drug Interactions Using Physiologically Based Pharmacokinetic Modeling CPT: Pharmacometrics & Systems Pharmacology. Jan, 2021 | Pubmed ID: 33217171 Pharmacokinetics of Benznidazole in Experimental Chronic Chagas Disease Using the Swiss Mouse-Berenice-78 Trypanosoma Cruzi Strain Model Antimicrobial Agents and Chemotherapy. Jan, 2021 | Pubmed ID: 33168611 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. Jan, 2021 | Pubmed ID: 33073366 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). , 2020, , 566 Pharmaceutics. Nov, 2020 | Pubmed ID: 33255861 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. Nov, 2020 | Pubmed ID: 33147873 Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products The AAPS Journal. Aug, 2020 | Pubmed ID: 32830289 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. Jun, 2020 | Pubmed ID: 32570975 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. Nov, 2020 | Pubmed ID: 32335930 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. Feb, 2020 | Pubmed ID: 31783158 Integrating Drug- and Formulation-Related Properties With Gastrointestinal Tract Variability Using a Product-Specific Particle Size Approach: Case Example Ibuprofen Journal of Pharmaceutical Sciences. Dec, 2019 | Pubmed ID: 31539541 Pharmacometrics, Physiologically Based Pharmacokinetics, Quantitative Systems Pharmacology-What's Next?-Joining Mechanistic and Epidemiological Approaches CPT: Pharmacometrics & Systems Pharmacology. Jun, 2019 | Pubmed ID: 31179639 Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended-Release Case Study Journal of Clinical Pharmacology. Sep, 2019 | Pubmed ID: 31087554 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. Apr, 2019 | Pubmed ID: 30681295 Non-Procrustean Pathways for Complex Generic Drugs Development Therapeutic Delivery. Sep, 2018 | Pubmed ID: 30189807 Past, Present, and Future of Bioequivalence: Improving Assessment and Extrapolation of Therapeutic Equivalence for Oral Drug Products Journal of Pharmaceutical Sciences. Oct, 2018 | Pubmed ID: 29935299 Author Spotlight: Advancing Organoid Generation for Drug Development Using iPSC Janny Pineiro-Llanes1, Lais da Silva1, John Huang2, Rodrigo Cristofoletti1 1Center for Pharmacometrics & Systems Pharmacology, Department of Pharmaceutics, University of Florida, 2TheWell Bioscience, Inc JoVE 66277 Bioingegneria
Author Spotlight: Advancing Organoid Generation for Drug Development Using iPSC Janny Pineiro-Llanes1, Lais da Silva1, John Huang2, Rodrigo Cristofoletti1 1Center for Pharmacometrics & Systems Pharmacology, Department of Pharmaceutics, University of Florida, 2TheWell Bioscience, Inc JoVE 66277 Bioingegneria