Marilyn N. Martinez Center for Veterinary Medicine, Office of New Animal Drug Evaluation US Food and Drug Administration Biography Publications Institution JoVE Articles Marilyn N. Martinez Dr. Marilyn N. Martinez received her Ph.D. with High Honors from the Georgetown School of Medicine Department of Physiology and Biophysics. is uniquely responsible for overseeing the resolution of all complex regulatory issues associated with veterinary pharmacokinetics (PK) and biopharmaceutics. In recognition of her leadership in the application of state-of-the-art technologies as a tool for insuring the safety and effectiveness of new animal drug products, she was promoted to Senior Biomedical Research Scientist at the FDA (2001). This position is the equivalent of a Full Professor in an academic institution. Because of her accomplishments, she serves on a team of senior scientists who serve as an advisor to US FDA’s Center for Veterinary Medicine (CVM) Office of New Animal Drug Evaluation (ONADE). She is a Fellow of the American Association of Pharmaceutical Scientists, Controlled Release Society, and Distinguished Fellow of the American Academy of Veterinary Pharmacology and Therapeutics. She is author or co-author of approximately 100 peer review publications. Publications The Publication of Studies Involving the Use of Human Critically Important Antimicrobial Agents in Veterinary Species Journal of Veterinary Pharmacology and Therapeutics. 11, 2021 | Pubmed ID: 34378797 Comparison of Canine and Human Physiological Factors: Understanding Interspecies Differences That Impact Drug Pharmacokinetics The AAPS Journal. 04, 2021 | Pubmed ID: 33907906 Evaluation of Partial Area Under the Curve in Bioequivalence Studies Using Destructive Sampling Design Journal of Veterinary Pharmacology and Therapeutics. Jul, 2021 | Pubmed ID: 33615485 An Introduction to the JVPT Special Issue on Antimicrobial Drugs Journal of Veterinary Pharmacology and Therapeutics. 03, 2021 | Pubmed ID: 32997371 The Impact of Infection and Inflammation on Drug Metabolism, Active Transport, and Systemic Drug Concentrations in Veterinary Species Drug Metabolism and Disposition: the Biological Fate of Chemicals. 08, 2020 | Pubmed ID: 32503881 Expert Discussion of the Role of Rate Constant Versus Clearance Approaches to Define Drug Pharmacokinetics: Theoretical and Clinical Considerations The AAPS Journal. 01, 2020 | Pubmed ID: 31907706 Reconciling Human-Canine Differences in Oral Bioavailability: Looking Beyond the Biopharmaceutics Classification System The AAPS Journal. 08, 2019 | Pubmed ID: 31396733 Eukaryotic Cell Culture Media Affect Macrolide Minimum Inhibitory Concentrations but Not Resistance Interpretation for Foodborne Pathogens Journal of Global Antimicrobial Resistance. 09, 2019 | Pubmed ID: 31176074 Danazol Oral Absorption Modelling in the Fasted Dog: An Example of Mechanistic Understanding of Formulation Effects on Drug Pharmacokinetics European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V. Aug, 2019 | Pubmed ID: 31150808 Questions Associated with the Development of Novel Drugs Intended for the Treatment of Bacterial Infections in Veterinary Species Veterinary Journal (London, England : 1997). Jun, 2019 | Pubmed ID: 31113568 A Simple Approach for Comparing the In Vitro Dissolution Profiles of Highly Variable Drug Products: a Proposal The AAPS Journal. 06, 2018 | Pubmed ID: 29942983 Population Variability in Animal Health: Influence on Dose-exposure-response Relationships: Part I: Drug Metabolism and Transporter Systems Journal of Veterinary Pharmacology and Therapeutics. Aug, 2018 | Pubmed ID: 29917248 Population Variability in Animal Health: Influence on Dose-exposure-response Relationships: Part II: Modelling and Simulation Journal of Veterinary Pharmacology and Therapeutics. Aug, 2018 | Pubmed ID: 29806231 Formulation Characteristics and in Vitro Release Testing of Cyclosporine Ophthalmic Ointments International Journal of Pharmaceutics. Jun, 2018 | Pubmed ID: 29684560 Proposed Method for Estimating Clinical Cut-off (CO) Values: An Attempt to Address Challenges Encountered when Setting Clinical Breakpoints for Veterinary Antimicrobial Agents Veterinary Journal (London, England : 1997). 10, 2017 | Pubmed ID: 29153105 What Does It "Mean"? A Review of Interpreting and Calculating Different Types of Means and Standard Deviations Pharmaceutics. Apr, 2017 | Pubmed ID: 28406450 Exploring Canine-Human Differences in Product Performance. Part II: Use of Modeling and Simulation to Explore the Impact of Formulation on Ciprofloxacin In Vivo Absorption and Dissolution in Dogs The AAPS Journal. 05, 2017 | Pubmed ID: 28265981 When Is It Important to Measure Unbound Drug in Evaluating Nanomedicine Pharmacokinetics? Drug Metabolism and Disposition: the Biological Fate of Chemicals. 12, 2016 | Pubmed ID: 27670412 Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid Journal of Pharmaceutical Sciences. Nov, 2016 | Pubmed ID: 27659159 Examining the Use of a Mechanistic Model to Generate an In Vivo/In Vitro Correlation: Journey Through a Thought Process The AAPS Journal. 09, 2016 | Pubmed ID: 27312260 Erratum To: Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin The AAPS Journal. Nov, 2016 | Pubmed ID: 27215600 Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin The AAPS Journal. 07, 2016 | Pubmed ID: 27116024 Canine Gastrointestinal Physiology: Breeds Variations That Can Influence Drug Absorption European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V. Nov, 2015 | Pubmed ID: 26409436 Demonstrating Comparative in Vitro Bioequivalence for Animal Drug Products Through Chemistry and Manufacturing Controls and Physicochemical Characterization: a Proposal The AAPS Journal. Mar, 2015 | Pubmed ID: 25609223 Challenges in Exploring the Cytochrome P450 System As a Source of Variation in Canine Drug Pharmacokinetics Drug Metabolism Reviews. May, 2013 | Pubmed ID: 23432217 Drug Solubility Classification in the Bovine Journal of Veterinary Pharmacology and Therapeutics. Apr, 2012 | Pubmed ID: 22413796 Drug Solubility Classification in the Dog Journal of Veterinary Pharmacology and Therapeutics. Apr, 2012 | Pubmed ID: 22413795 The Scientific Basis for Establishing Solubility Criteria for Veterinary Species Journal of Veterinary Pharmacology and Therapeutics. Apr, 2012 | Pubmed ID: 22413794 Dosing Regimen Matters: the Importance of Early Intervention and Rapid Attainment of the Pharmacokinetic/pharmacodynamic Target Antimicrobial Agents and Chemotherapy. Jun, 2012 | Pubmed ID: 22371890 Terminology Challenges: Defining Modified Release Dosage Forms in Veterinary Medicine Journal of Pharmaceutical Sciences. Aug, 2010 | Pubmed ID: 20213837 Breakout Session Summary from AAPS/CRS Joint Workshop on Critical Variables in the in Vitro and in Vivo Performance of Parenteral Sustained Release Products Journal of Controlled Release : Official Journal of the Controlled Release Society. Feb, 2010 | Pubmed ID: 19808069 Factors Influencing the Gastric Residence of Dosage Forms in Dogs Journal of Pharmaceutical Sciences. Mar, 2009 | Pubmed ID: 18661535 AAPS/RAPS/CAPRA Collaborative Program: Exploring the Challenges of Drug Regulation in a Global Environment: Clinical Concerns AAPS PharmSci. Oct, 2003 | Pubmed ID: 15198515 A Mechanistic Approach to Understanding the Factors Affecting Drug Absorption: a Review of Fundamentals Journal of Clinical Pharmacology. Jun, 2002 | Pubmed ID: 12043951 Canine Intestinal Organoids in a Dual-Chamber Permeable Support System Vojtech Gabriel1, Christopher Zdyrski1, Dipak K. Sahoo2, Kimberly Dao3, Agnes Bourgois-Mochel2, Todd Atherly3, Marilyn N. Martinez4, Donna A. Volpe5, Jamie Kopper2, Karin Allenspach2,3, Jonathan P. Mochel1,3 1Department of Biomedical Sciences, College of Veterinary Medicine, Iowa State University, 2Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Iowa State University, 33D Health Solutions Inc., 4Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, 5Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration JoVE 63612 Immunologia e infezioni
Canine Intestinal Organoids in a Dual-Chamber Permeable Support System Vojtech Gabriel1, Christopher Zdyrski1, Dipak K. Sahoo2, Kimberly Dao3, Agnes Bourgois-Mochel2, Todd Atherly3, Marilyn N. Martinez4, Donna A. Volpe5, Jamie Kopper2, Karin Allenspach2,3, Jonathan P. Mochel1,3 1Department of Biomedical Sciences, College of Veterinary Medicine, Iowa State University, 2Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Iowa State University, 33D Health Solutions Inc., 4Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, 5Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration JoVE 63612 Immunologia e infezioni