From Wikipedia,
the free encyclopedia
Pre-clinical development
is a stage in the development of a
new drug that begins before
clinical trials (testing in
humans) can begin, and during
which important safety and
pharmacology data is
collected.
The main goals of pre-clinical
studies are to determine a drug's
toxicity and
pharmacokinetics through
animal testing. This data
allows researchers to estimate a
safe starting dose of the drug for
clinical trials in humans.
Pre-clinical studies must adhere
to
Good Laboratory Practices (GLP)
in
ICH Guidelines to be
acceptable for submission to
regulatory agencies such as the
Food & Drug Administration in
the United States.
Typically, both
in vitro and
in vivo tests will be
performed. Studies of a drug's
toxicity include which organs
are targeted by that drug, as well
as if there are any long-term
carcinogenic effects or toxic
effects on mammalian
reproduction.
Animal testing in the
research-based pharmaceutical
industry has been reduced in
recent years both for ethical and
cost reasons. Typically, animal
testing involves two species
(often
rodent and
dog). The information
collected from these studies is
vital so that safe human testing
can begin.
