| In preclinical drug development, in vitro
studies are establishing themselves in a
more prominent position. Because of
ethical considerations, an increasing
number of in vivo tests have been replaced
by in vitro experiments. These tests are
recommended by organisations such as
the Interagency Coordinating Committee
on the Validation of Alternative Methods
(ICCVAM), and (draft) Test Guidelines are
accepted or sent for consideration to the
European Medicines Agency (EMEA),
the US Food and Drug Administration
(FDA) and the Organization of Economic
Cooperation and Development (OECD),
which are all part of the International
Conference on Harmonization of
Technical Requirements for Registration
of Pharmaceuticals for Human use (ICH).
The National Institutes of Health (NIH) and
other federal agencies are committed to the
welfare of research animals. These animals
are protected by law, regulations and
policies to ensure that companies are sued
as rarely as possible and with special care
taken in order to ensure animals’ comfort.
Alternative test methods are those that
accomplish one or more of the three ‘Rs’:
- Reducing the number of animals used
in testing through improved science
and experimental design
- Refining experimental procedures
so that animals experience less pain
and distress
- Replacing animals with non-animal
systems where possible
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