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Progenix
Research offers a comprehensive range of pre-clinical toxicology studies
on pharmaceuticals and biotechnology products:
Safety
pharmacology
A comprehensive range of safety pharmacology studies are available
including cardiovascular, central nervous system and respiratory
assessments in dogs, non-human primates and rodents. These studies are
in compliance with the requirements for "core battery" testing using
both in-vivo and ex-vivo tests.
Single
dose toxicity
Single dose toxicity studies conducted in rats, mice, rabbits, dogs,
non-human primates, mini-pigs using oral, intravenous, intramuscular,
subcutaneous, intradermal, intraperitoneal, inhalation, dermal and other
specialised routes of exposure. Studies are designed to meet
International Conference on Harmonisation (ICH) requirements or client
specific study plans. |
Repeated dose
toxicity
14-day, 28-day, 3-month and 6-month toxicity studies are carried out in a
full range of species: rats, mice, rabbits, dogs, non-human primates and
mini-pigs. All routes of exposure as described above can be accommodated as
well as immunotoxicity and neurotoxicity testing.
Reproductive
toxicology
The full regulatory spectrum of validated studies to investigate fertility
and early embryonic development, pre and post natal development, embryo and
foetal development is available as well as bespoke reproductive projects in
primates. The Progenix primate breeding unit affords a unique opportunity
for protocol designs drawing on the profiled breeding population.
Irritancy
& sensitisation studies
Skin and eye irritation, skin sensitisation, phototoxicity.
Carcinogenicity
Life-time bioassays in rats and mice including oral, dermal and inhalation
studies.
Genotoxicity
Bacterial gene mutation assays (Ames test), in-vitro and in-vivo
chromosome aberration studies, in-vitro mouse lymphoma assays,
in-vivo micronucleus tests.
Toxicokinetics/pharmacokinetics
Full facilities for toxicokinetic determinations either stand alone or
concurrent with toxicity studies.
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