Terminology challenges: defining modified release dosage forms in veterinary medicine.
Terminologies for describing dosage form release characteristics for human pharmaceuticals have been addressed by bodies such as the US Food and Drug Administration (FDA), the International Conference on Harmonization (ICH), and the US Pharmacopeia (USP). While the definition for terms such as "immediate release," "modified release," "extended release," and "delayed release" are now well accepted for human pharmaceuticals, confusion still exists within the veterinary community. In part, this confusion is attributable to differences between human and veterinary dosage forms (such as the preponderance of parenteral vs. oral extended release products for use in animals vs. the focus on oral extended release formulations for human use) which reflect interspecies differences in physiology and conditions of use. It also simply reflects a lack of attention to existing definitions. 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.
Martinez
Marilyn N
MN
Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Rockville, Maryland 20855, USA. marilyn.martinez@fda.hhs.gov
Lindquist
Danielle
D
Modric
Sanja
S
D000818:Animals; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations / Q000008:administration & dosage*; D017277:Drug Approval; D010599:Pharmacokinetics; D009626:Terminology as Topic; D014481:United States; D014486:United States Food and Drug Administration; D019155:Veterinary Drugs / Q000008:administration & dosage*; D014730:Veterinary Medicine
D003692:Delayed-Action Preparations; D019155:Veterinary Drugs