The evaluation of potential toxicological effects of all pharmaceuticals
is required prior to product registration. The safety evaluation of these products
is performed in mammalian systems, for which extensive background data can be
of great value in the evaluation of responses observed in the studies. Huntingdon
Life Sciences, with over fifty years experience in this work is ideally placed
to assist you with this testing.
We have the capacity and a wide variety of the necessary skills,
enabling us to design and conduct all study types in accordance with the requirements
of the product under test. For example, all the common dosing routes, such as
dermal, inhalation, intravenous injection and oral are available, as well as
some other specialist routes such as vascular infusion and intrathecal. All
areas of regulatory toxicology enabling a Phase I clinical trial can be covered:
- Rodent and non-rodent single dose studies
- Acute systemic toxicity characterisation - to thoroughly describe the
single dose toxicity
- Rodent and non-rodent repeat-dose studies (short-term)
- Range-finding studies - in all regulatory acceptable species and dose
routes, used primarily to set dosages for initial sub-chronic testing
- Two or four-week repeat dose toxicity studies in all regulatory acceptable
species and dose routes
- Reproductive toxicology studies covering pregnancy and fertility
- Embryo-fetal development - monitoring survival, growth and physical
development of the embryo and fetus when the mother is treated from implantation
to closure of the hard palate (end of the period of ‘major’
organogenesis). Two species (one rodent and one non-rodent, in principle)
to be assessed prior to inclusion of women of child bearing potential
in Japan and EU. Not required for trials initiated in the US
- Study of fertility and early embryonic development to implantation -
Monitoring gamete development, mating behaviour, fertility, implantation
and embryonic development / survival to the time of implantation. At least
a study of males is traditionally performed in Japan prior to Phase I;
not needed in US or EU if supported by histological examination of male
organs from repeat-dose toxicity studies. Female study required prior
to inclusion of women of child bearing potential in Japan
Together with our extensive support departments, we provide
the full comprehensive package of tests required for registration and market
authorisation, which ultimately helps speed your product to market.
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