Type of Posting: General Announcement
Posting Date: 22–May–2012
USP is seeking comments on the Stimuli article “Solubility Criteria for Veterinary Drugs.” The Stimuli article, which will be formally published for comment in Pharmacopeial Forum (PF) 38(4), contains an introduction to a proposed new general chapter for veterinary products. This Stimuli article is posted in advance of publication in PF to provide stakeholders adequate time to review and comment before the Solubility Criteria for Veterinary Products Workshop on November 7–8, 2012.
This Stimuli article is the first step in the development of a general chapter to evaluate solubility criteria for veterinary drug products. Currently, the criteria for classifying drug solubility are based on human physiology, which is not appropriate for veterinary species. This paper discusses a proposal for appropriate criteria to be used in veterinary species. The new general chapter initially will discuss parameters and conditions for dogs and cattle, but may be revised in the future to include other animal species.
The Solubility Criteria for Veterinary Products Workshop will be held at USP’s Rockville, MD headquarters. The workshop will provide a forum for discussing public comments and suggestions related to the Stimuli article, offering veterinary industry insights and conveying information for other approaches and animal species to be included in the new general chapter.
The deadline for submitting comments on the Stimuli article in is September 30, 2012. Comments and suggestions should be submitted to Margareth Marques, Ph.D., Senior Scientific Liaison (301-816-8106 or mrm@usp.org).