Division II.6.3.3.1.3
United Kingdom
Guidance on the design of repeat dose (90-day) studies is provided in VICH GL31: Studies to evaluate the safety of residues of veterinary drugs in human food: repeat-dose (90 days) toxicity testingf1 and shall be followed. Any departures from established guidance shall be justified and the impact discussed.
Annotations
Footnotes
- f1
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VICH GL31 Safety studies for veterinary drug residues in human food: repeat-dose (90) toxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001478.jsp&mid=WC0b01ac058002dd37).