Hoeford is licensed to perform Abnormal Toxicity/Absence of Toxicity testing (ATT) for customers that require the test for batch release of medicinal products.

Some territories still require products to be tested by ATT before they will allow release. These products may be listed in the pharmacopeia monographs, or this may be a safety approach implemented by that territory for the release of new products.

The current regulatory stance is not to perform the test for the UK or EU, however some territories around the world still request/require it for certain drugs, including China, Russian, Indonesia, Japan and South Korea.

Testing will only be permitted if the intended release country will not accept the product without the test being performed and there will be a negative health impact if the product is not released. Scientific justification is required for assessment by the UK Home Office before any study is undertaken.

How is it done?

European Pharmacopeia 9.0:

• 5 mice general safety test, 5 mice and 2 guinea pigs for immunosera and vaccines for human and veterinary use
• 24-hour initial test for a general safety test
• 7-day initial test for vaccines and immunosera for human use
• 14-day initial test for vaccines for veterinary use
   

United States Pharmacopeia 42:

• 5 mice general safety test, 2 mice and 2 guinea pigs for biologics
• 48-hours for general safety test
• If one or more deaths or more than one animal showing a reaction or outward symptoms then it must be repeated using 10 mice for 48 hours
• 7-day initial test for biologics
• Failure to meet pass requirements of no deaths or signs of ill health attributable to known effects of the sample and no weight loss - repeat using one or both species which did not meet requirements. Repeat for 7 days