Challenges associated with the demonstration of bioequivalence of intramammary products in ruminants

Autor:	C, Lainesse, R, Gehring, K, Pasloske, G, Smith, S, Soback, S, Wagner, T, Whittem
Rok vydání:	2012
Předmět:	Dosage Forms Drug Administration Routes Veterinary Drugs Mastitis Ruminants Hydrogen-Ion Concentration Models Biological Mammary Glands Animal Anti-Infective Agents Therapeutic Equivalency Research Design Animals Lactation Female
Zdroj:	Journal of veterinary pharmacology and therapeutics. 35
ISSN:	1365-2885
Popis:	This article explores the numerous challenges encountered when the goal is to demonstrate bioequivalence (BE) between test and reference intramammary (IMM) products in ruminants. Numerous pathophysiological factors of mastitis and physicochemical properties of IMM formulations are implicated in the difficulties in confirming BE for this dosage form. Advantages and disadvantages of current BE study designs are discussed, and alternative perspectives are outlined. Ongoing and future research increasing our knowledge of the pharmacokinetics and pharmacodynamics of antimicrobial drugs delivered through this route is crucial to better understanding the implications of clinically significant formulation differences in the demonstration of BE and may also help in developing more effective IMM formulations for ruminants.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=pmid________::f59de0e44d3271436cba37526ea1d070 https://pubmed.ncbi.nlm.nih.gov/22413793 Zobrazit plný text záznamu Plný text