The
Ph. Eur. is proposing an amendment for the pyrogen test monograph (2.6.8). The
only change is in directing users to consider using an alternative to the
rabbit model.
The
change states:
“In
accordance with the provisions of the European Convention for the Protection of
Vertebrate Animals used for Experimental and Other Scientific Purposes, tests
must be carried out in such a way as to use the minimum number of animals and
to cause the least pain, suffering, distress or lasting harm. Wherever possible
and after product-specific validation, the pyrogen test is replaced by the
monocyte-activation test (2.6.30).”
Interestingly,
the recommendation is towards the MAT rather than LAL testing.
Posted by Tim Sandle
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