Clinical trials in phase III have several objectives, for example :
-
Proving the therapeutic effectiveness of the compound under
realistic usage conditions;
-
Demonstrating that the compound is as effective as existing drugs or
forms of treatment, if not more so;
-
Rigorously comparing the patient groups
treated with the candidate drug with the control groups
to whom a placebo has been given;
-
Adjusting the
dosage, according to the age of patients, the pathologies
from which they are suffering
and the other drugs they are receiving;
-
Testing different methods of administering
the drug (tablet, syrup, inhaler, etc.)
| Duration: may last several years
The lead molecules are administered to a large number
of patients (1,000 to 8,000), coming from various
regions and divided into independent groups. |
These trials, which are conducted along with
other tests on rodents, allow for even
more precise understanding
of
the drug’s safety profile, the occurrence
of undesirable side-effects, and long-term
toxicity. These
are all documented
in a manner satisfactory to the regulatory
authorities. During this stage, the scientists are able
to select the lead
molecule that possesses
the characteristics
required
to become a drug. The pharmaceutical company prepares and then
submits an application to present a drug
to the regulatory
authorities
(Health Canada, U.S. Food and Drug Administration),
who examine it and decide if the drug can
be sold in the country
under their jurisdiction. The examination
process of these authorities can take more
than a year. While the regulatory
bodies examine the results provided by the pharmaceutical
companies,
the data necessary
for large scale production of the drug
are transmitted to the
factory. Chemists,
engineer-chemists and process chemistry
specialists apply their
expertise
to the production of
the drug in very large quantities (by which
we mean: tons) This scale-increasing work
is complex
and must
be precise,
for the drugs produced on large scale in
future years must have the exact same properties
as
the several
kilograms
produced in the laboratory for use in the
clinical trials. Production is subject
to very strict
quality control. As soon as the drug
is approved, large scale production is launched and the
product commercialized.
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