| The basic principles in the discovery and
development of a drug may be summarized as follows : Discovery
| The discovery
stage can last up to 6 years and experts estimate its
average
cost to be $US335m (2000). |
The proteins produced by transcription of
our genes ensure that our body’s main biological functions
are carried out.
A faulty gene or protein is often what lies behind a disease. To treat a particular disease, it is first necessary to
identify the biological
targets (i.e., a protein or other
biopolymer)
known to be involved in this disease’s etiology,
and then discover the compound, or compounds, that have
an effective
and specific therapeutic capability and a minimum number
of side-effects. Specialists in the biological
sciences and medicinal
chemistry work in close collaboration throughout the
entire process
of drug discovery. Development
| The development of the drug
can take as long as a decade, at an average cost estimated
at $US467m (2000). |
Once the compound, or compounds, have been
chosen, they must be transformed into a drug. This process
involves several series of trials on animals and humans,
all intended to ensure that the drug may be administered
to humans with minimum possible risk and that it is superior
to, or otherwise complements, existing drugs with the same
therapeutic function. These
trials are subject to the rigorous
controls required by the regulatory
authorities,
such as Health
Canada or the
US
Food and Drug Administration (FDA).
In addition to specialists in biology
and therapeutic chemistry, the discovery
of a new drug involves the collaboration
of
pharmaceutical R&D specialists and clinical research
teams, composed of doctors, nurses and other health specialists. |