Office of New Animal Drug Evaluation
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.
A mechanistic approach to understanding the factors affecting drug absorption: a review of fundamentals.
Journal of clinical pharmacology Jun, 2002 | Pubmed ID: 12043951
AAPS/RAPS/CAPRA collaborative program: exploring the challenges of drug regulation in a global environment: clinical concerns.
AAPS pharmSci Oct, 2003 | Pubmed ID: 15198515
Factors influencing the gastric residence of dosage forms in dogs.
Journal of pharmaceutical sciences Mar, 2009 | Pubmed ID: 18661535
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
Terminology challenges: defining modified release dosage forms in veterinary medicine.
Journal of pharmaceutical sciences Aug, 2010 | Pubmed ID: 20213837
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
The scientific basis for establishing solubility criteria for veterinary species.
Journal of veterinary pharmacology and therapeutics Apr, 2012 | Pubmed ID: 22413794
Drug solubility classification in the dog.
Journal of veterinary pharmacology and therapeutics Apr, 2012 | Pubmed ID: 22413795
Drug solubility classification in the bovine.
Journal of veterinary pharmacology and therapeutics Apr, 2012 | Pubmed ID: 22413796
Challenges in exploring the cytochrome P450 system as a source of variation in canine drug pharmacokinetics.
Drug metabolism reviews May, 2013 | Pubmed ID: 23432217
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
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
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
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
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
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
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
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
What Does It "Mean"? A Review of Interpreting and Calculating Different Types of Means and Standard Deviations.
Pharmaceutics Apr, 2017 | Pubmed ID: 28406450
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
Formulation characteristics and in vitro release testing of cyclosporine ophthalmic ointments.
International journal of pharmaceutics Jun, 2018 | Pubmed ID: 29684560
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
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
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
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
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
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
Reconciling Human-Canine Differences in Oral Bioavailability: Looking beyond the Biopharmaceutics Classification System.
The AAPS journal 08, 2019 | Pubmed ID: 31396733
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
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
An introduction to the JVPT special issue on antimicrobial drugs.
Journal of veterinary pharmacology and therapeutics 03, 2021 | Pubmed ID: 32997371
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
Comparison of Canine and Human Physiological Factors: Understanding Interspecies Differences that Impact Drug Pharmacokinetics.
The AAPS journal 04, 2021 | Pubmed ID: 33907906
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
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,
3, 3D 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