M N Martinez

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint Allometric scaling of clearance in dogs
    M Martinez
    Division of Therapeutic Drugs for Food Animals HFV 130, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 32:411-6. 2009
  2. doi request reprint Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin
    Marilyn Martinez
    The Food and Drug Administration, Rockville, MD, USA
    AAPS J 18:886-97. 2016
  3. pmc Demonstrating comparative in vitro bioequivalence for animal drug products through chemistry and manufacturing controls and physicochemical characterization: a proposal
    Marilyn N Martinez
    USFDA Center for Veterinary Medicine, Office of New Animal Drug Evaluation, 7500 Standish Place, HFV 100, Rockville, Maryland, 20855, USA
    AAPS J 17:307-12. 2015
  4. doi request reprint Challenges in exploring the cytochrome P450 system as a source of variation in canine drug pharmacokinetics
    Marilyn N Martinez
    Center for Veterinary Medicine, U S Food and Drug Administration, 7520 Standish Place, HFV 100, Rockville, MD 20855, USA
    Drug Metab Rev 45:218-30. 2013
  5. pmc Dosing regimen matters: the importance of early intervention and rapid attainment of the pharmacokinetic/pharmacodynamic target
    Marilyn N Martinez
    Food and Drug Administration, Center for Veterinary Medicine, Rockville, Maryland, USA
    Antimicrob Agents Chemother 56:2795-805. 2012
  6. doi request reprint Drug solubility classification in the bovine
    M N Martinez
    Food and Drug Administration Center for Veterinary Medicine, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 35:93-7. 2012
  7. doi request reprint Drug solubility classification in the dog
    M N Martinez
    Center for Veterinary Medicine, US Food and Drug Administration, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 35:87-91. 2012
  8. doi request reprint The scientific basis for establishing solubility criteria for veterinary species
    M N Martinez
    Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 35:81-6. 2012
  9. pmc Pharmacogenetic and metabolic differences between dog breeds: their impact on canine medicine and the use of the dog as a preclinical animal model
    Steven Fleischer
    Center for Veterinary Medicine, The Food and Drug Administration, 7500 Standish Place, HFV 130, Rockville, Massachusetts 20855, USA
    AAPS J 10:110-9. 2008
  10. doi request reprint Factors influencing the gastric residence of dosage forms in dogs
    Marilyn N Martinez
    US Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, 7500 Standish Place, Rockville, Maryland 20855, USA
    J Pharm Sci 98:844-60. 2009

Detail Information

Publications33

  1. doi request reprint Allometric scaling of clearance in dogs
    M Martinez
    Division of Therapeutic Drugs for Food Animals HFV 130, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 32:411-6. 2009
    ....
  2. doi request reprint Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin
    Marilyn Martinez
    The Food and Drug Administration, Rockville, MD, USA
    AAPS J 18:886-97. 2016
    ..The latter was essential for understanding the potential challenges that may be encountered when introducing a formulation into a patient population...
  3. pmc Demonstrating comparative in vitro bioequivalence for animal drug products through chemistry and manufacturing controls and physicochemical characterization: a proposal
    Marilyn N Martinez
    USFDA Center for Veterinary Medicine, Office of New Animal Drug Evaluation, 7500 Standish Place, HFV 100, Rockville, Maryland, 20855, USA
    AAPS J 17:307-12. 2015
    ....
  4. doi request reprint Challenges in exploring the cytochrome P450 system as a source of variation in canine drug pharmacokinetics
    Marilyn N Martinez
    Center for Veterinary Medicine, U S Food and Drug Administration, 7520 Standish Place, HFV 100, Rockville, MD 20855, USA
    Drug Metab Rev 45:218-30. 2013
    ..It is with these objectives in mind that we provide an overview of what is currently known about canine CYPs with the hope that it will encourage further exploration into this important area of research...
  5. pmc Dosing regimen matters: the importance of early intervention and rapid attainment of the pharmacokinetic/pharmacodynamic target
    Marilyn N Martinez
    Food and Drug Administration, Center for Veterinary Medicine, Rockville, Maryland, USA
    Antimicrob Agents Chemother 56:2795-805. 2012
    ..To support these recommendations, we briefly discuss data on inoculum effects, persister cells, and the concept of time within some defined mutation selection window...
  6. doi request reprint Drug solubility classification in the bovine
    M N Martinez
    Food and Drug Administration Center for Veterinary Medicine, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 35:93-7. 2012
    ..These points are discussed below and alternative perspectives for consideration with regard to possible modification of solubility criteria for ruminants are presented...
  7. doi request reprint Drug solubility classification in the dog
    M N Martinez
    Center for Veterinary Medicine, US Food and Drug Administration, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 35:87-91. 2012
    ....
  8. doi request reprint The scientific basis for establishing solubility criteria for veterinary species
    M N Martinez
    Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 35:81-6. 2012
    ..Each of these factors needs to be considered when evaluating potential interspecies differences in drug solubility...
  9. pmc Pharmacogenetic and metabolic differences between dog breeds: their impact on canine medicine and the use of the dog as a preclinical animal model
    Steven Fleischer
    Center for Veterinary Medicine, The Food and Drug Administration, 7500 Standish Place, HFV 130, Rockville, Massachusetts 20855, USA
    AAPS J 10:110-9. 2008
    ..Understanding these breed differences will improve canine population predictions (for canine drug products) and may be of value when extrapolating toxicology data from dogs to humans...
  10. doi request reprint Factors influencing the gastric residence of dosage forms in dogs
    Marilyn N Martinez
    US Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, 7500 Standish Place, Rockville, Maryland 20855, USA
    J Pharm Sci 98:844-60. 2009
    ..Therefore, this review provides an examination of each of these factors and their potential impact on canine oral drug absorption characteristics...
  11. doi request reprint The pharmacogenomics of P-glycoprotein and its role in veterinary medicine
    M Martinez
    Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 31:285-300. 2008
    ....
  12. doi request reprint Breakout session summary from AAPS/CRS joint workshop on critical variables in the in vitro and in vivo performance of parenteral sustained release products
    Marilyn N Martinez
    US Food and Drug Administration, Center for Veterinary, Medicine, Rockville, MD 20855, United States
    J Control Release 142:2-7. 2010
    ..To foster discussion, the workshop provided two afternoon breakout sessions where critical questions were explored. This manuscript captures the results of those discussions...
  13. doi request reprint Antimicrobial drug resistance
    Marilyn Martinez
    Office of New Animal Drug Evaluation HFV 130, Center for Veterinary Medicine Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, USA
    Handb Exp Pharmacol . 2010
    ..Finally, the differences between bacterial tolerance and bacterial resistance are considered, and the potential for non-traditional anti-infective therapies is discussed...
  14. doi request reprint Terminology challenges: defining modified release dosage forms in veterinary medicine
    Marilyn N Martinez
    Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Rockville, Maryland 20855, USA
    J Pharm Sci 99:3281-90. 2010
    ..In an effort to remedy this problem, this manuscript reflects an initial effort to suggest definitions that may be appropriate for describing formulation effects in veterinary medicine...
  15. doi request reprint Patient variation in veterinary medicine: part I. Influence of altered physiological states
    M Martinez
    Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 33:213-26. 2010
    ..Ultimately, failure to identify appropriate covariates can lead to substantial error when predicting the dose-exposure relationship within a population...
  16. doi request reprint Current challenges facing the determination of product bioequivalence in veterinary medicine
    M N Martinez
    US Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 33:418-33. 2010
    ..This manuscript highlights many of the unresolved challenges currently impacting the evaluation of product bioequivalence in veterinary medicine, and provides a summary of the associated scientific complexities with each of these issues...
  17. pmc Factors influencing the use and interpretation of animal models in the development of parenteral drug delivery systems
    Marilyn N Martinez
    US FDA Center for Veterinary Medicine, Rockville, Maryland 20855, USA
    AAPS J 13:632-49. 2011
    ..Understanding interspecies differences in the movement and absorption of molecules is important to the interpretation of data generated through the use of animal models when studying parenteral drug delivery...
  18. doi request reprint In vitro and in vivo considerations associated with parenteral sustained release products: a review based upon information presented and points expressed at the 2007 Controlled Release Society Annual Meeting
    Marilyn Martinez
    US Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Rockville, Maryland 20855, USA
    J Control Release 129:79-87. 2008
  19. ncbi request reprint Comparison of bovine in vivo bioavailability of two sulfamethazine oral boluses exhibiting different in vitro dissolution profiles
    M N Martinez
    FDA Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Rockville, MD, USA
    J Vet Pharmacol Ther 29:459-67. 2006
    ..However, the data also suggest that rumenal absorption may occur for some compounds. Therefore the degree to which variation in product in vitro dissolution profiles can be tolerated may be compound specific...
  20. pmc Preface: challenges and issues in veterinary pharmacology and animal health - 2005
    Marilyn Martinez
    Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD 20855, USA
    AAPS J 7:E266-71. 2005
  21. ncbi request reprint Feasibility of interspecies extrapolation in determining the bioequivalence of animal products intended for intramuscular administration
    M N Martinez
    Division of Therapeutic Drugs for Food Animals, FDA CVM, MPNII, Rockville, MD, USA
    J Vet Pharmacol Ther 24:125-35. 2001
    ..Nevertheless, marked interspecies differences were noted in the width and bounds of the confidence intervals about the differences in treatment means. Potential physiological and physico-chemical reasons for these findings are discussed...
  22. ncbi request reprint Interspecies allometric scaling. Part I: prediction of clearance in large animals
    I Mahmood
    Clinical Pharmacology and Toxicology Branch HFD 579, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Rockville, MD 20852, USA
    J Vet Pharmacol Ther 29:415-23. 2006
    ..For this reason, it is important to consider mechanisms for reducing the risk of extrapolation errors that can seriously affect target animal safety, therapeutic response, or the accuracy of withdrawal time predictions...
  23. ncbi request reprint Interspecies allometric scaling: prediction of clearance in large animal species: part II: mathematical considerations
    M Martinez
    Division of Therapeutic Drugs for Food Animals HFV 130, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 29:425-32. 2006
    ..Ultimately, these considerations are used to generate recommendations regarding the data to be included in the allometric prediction of clearance in large animal species...
  24. ncbi request reprint Introduction to the bioequivalence theme issue
    M N Martinez
    US Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Rockville, MD, USA Elanco Animal Health, A Division of Eli Lilly and Company, Greenfield, Indiana, USA
    J Vet Pharmacol Ther 35:1-2. 2012
    ..J. vet. Pharmacol. Therap. 35 (Suppl. 1), 1-2. This introduction provides an overview of the veterinary bioequivalence initiative and of the foundational goals and objectives of this theme issue...
  25. ncbi request reprint American academy of veterinary pharmacology and therapeutics 14th biennial symposium
    M Martinez
    Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Rockville, MD, USA
    J Vet Pharmacol Ther 28:495-8. 2005
  26. ncbi request reprint Challenges associated with the evaluation of veterinary product bioequivalence: an AAVPT perspective
    M Martinez
    Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 25:201-20. 2002
    ..This manuscript provides a summary of the concerns and discussions that transpired...
  27. ncbi request reprint Pharmacology of the fluoroquinolones: a perspective for the use in domestic animals
    Marilyn Martinez
    US Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Rockville, MD 20855, USA
    Vet J 172:10-28. 2006
    ..Although the review contains a large body of basic research information, it is intended that the contents of this review have relevance to both the research scientist and the veterinary medical practitioner...
  28. ncbi request reprint Veterinary drug delivery: Part VI
    Michael J Rathbone
    InterAg, 558 Te Rapa Road, P O Box 20055, Hamilton, New Zealand
    Adv Drug Deliv Rev 56:1339-44. 2004
  29. pmc Introduction: a welcome to the First Special Animal Health Issue of AAPS PharmSci
    Marilyn Martinez
    Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD 20855, USA
    AAPS PharmSci 4:E39. 2002
    ..The contributors are highly respected experts, providing invaluable insights into current issues and state-of-the-art advances within veterinary medicine...
  30. pmc Linking human and veterinary health: trends, directions and initiatives
    Marilyn Martinez
    Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD 20855, USA
    AAPS PharmSci 4:E32. 2002
    ....
  31. ncbi request reprint Applying the biopharmaceutics classification system to veterinary pharmaceutical products. Part II. Physiological considerations
    Marilyn Martinez
    Office of New Animal Drug Evaluation, Food and Drug Administration, Rockville, MD 20855, USA
    Adv Drug Deliv Rev 54:825-50. 2002
    ....
  32. ncbi request reprint Applying the biopharmaceutics classification system to veterinary pharmaceutical products. Part I: biopharmaceutics and formulation considerations
    Marilyn Martinez
    Office of New Animal Drug Evaluation, Food and Drug Administration, Rockville, MD 20855, USA
    Adv Drug Deliv Rev 54:805-24. 2002
    ..In this paper, we examine manufacturing and formulation variables that can affect drug bioavailability, and the potential for species-specific differences in the responses to these formulations...
  33. ncbi request reprint AUC/MIC: a PK/PD index for antibiotics with a time dimension or simply a dimensionless scoring factor?
    Pierre Louis Toutain
    UMR181 Physiopathologie et Toxicologie Expérimentales INRA, ENVT, 23 Chemin des Capelles, 31076 Toulouse cedex 03, France
    J Antimicrob Chemother 60:1185-8. 2007
    ..To accommodate the need for dose prediction during these novel therapeutic situations, we propose a general approach that is based on the targeted time interval over which some desired average concentration should be maintained...