ABSTRACT

Guidance for Industry: Target Animal Safety for Veterinary Pharmaceutical Products   [open pdf - 241KB]

"The purpose of this harmonized guidance is to provide recommendations regarding TAS [target animal safety] evaluation for regulatory submission of an Investigational Veterinary Pharmaceutical Product (IVPP), which is appropriate for determining the safety of an IVPP in the target animal, including identification of target organs, where possible, and confirmation of margin of safety, using the minimum number of animals appropriate for the studies."

Report Number:
VICH GL43
Publisher:
Date:
2009-04-24
Copyright:
Public Domain
Retrieved From:
Lessons Learned Information Sharing (LLIS)
Format:
pdf
Media Type:
application/pdf
URL:
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