Monday, 7 March 2016

Calling time on the General Safety Test

The General Safety Test is an animal test for  the detection of extraneous toxic contaminants and one which is sometimes undertaken for biological products intended for administration to humans. In the European Pharmacopoeia, the test is referred to as the ‘Abnormal Toxicity Test’; whereas in the United States Pharmacopeia, the test is the ‘General Safety Test’. Aside from some relatively minor differences relating to the size of the animals used, the numbers required, and with the interpretation of animals that appear ‘distressed’, the two compendial tests are essentially the same.

In relation to this test – long past its usefulness – Tim Sandle has written a review article for GMP Review. The reference is:

Sandle, T. (2016) Calling time on the General Safety Test, GMP Review, 14 (4): 11-13

For a copy, please contact Tim Sandle

 Posted by Dr. Tim Sandle