Division II.6.3.3.2.3
United Kingdom
Guidance on the design of repeat dose (chronic) studies is provided in VICH GL37: Studies to evaluate the safety of residues of veterinary drugs in human food: repeat-dose (chronic) 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 GL37 Safety of veterinary drugs in human food repeat-dose (chronic) toxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001481.jsp&mid=WC0b01ac058002dd37).