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U.S. Department of Health and Human Services

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Article, Chapter, or Book Title:  Drug solubility classification in the bovine
 
Author(s):  Martinez MN and Apley MD
 
Year:  2012
 
Month:  Mar
 
Journal Abbrev, Book Title, or Conference:  J Vet Pharmacol Therap
 
Journal Full Name:  Journal of Veterinary Pharmacology and Therapeutics
 
Volume:  35
 
Start Page:  93
 
End Page:  97
 
Key Words:  cattle, drug solubility, ruminants
 
Abstract:  Currently, the basis for solubility test conditions and the corresponding solubility criteria is derived from the tremendous wealth of information developed to support human pharmaceutical product development and regulation. However, there are several critical differences between the gastrointestinal tract of ruminants and monogastric species that can affect the conditions and criteria to be applied to the classification of drug solubility in cattle. These include the pH of the stomach, the volume of the stomach, the types of oral formulations, and the definition of highest dose. These points are discussed below and alternative perspectives for consideration with regard to possible modification of solubility criteria for ruminants are presented.
 
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