Many thousands of people across the world benefit from drugs today, from headache
cures to cancer treatments. But there are many more that suffer from disease
and genetic disorders for which there is not yet a cure.
The process for the discovery and developing of new drugs encompasses some
of the most exciting areas of modern science, yielding new products for the
improvement to health care. This can take up to 15 years and cost around $500
- $800 million for each new drug.
Early stages of research begins with a chemist making small amounts of a vast
array of potential drugs for a cell biologist to carry out in vitro (non animal) screening tests to generate a ‘lead’ drug. What follows
then are more comprehensive safety assessments to support future human use.
This may indeed involve the use of animals. As a consequence, legislative requirements
for safety testing continue to increase and become ever more stringent. Huntingdon
Life Sciences is committed to the task of ensuring new drugs developed by pharmaceutical
companies reach the markets safely.
Of the 15 years of drug development about 10 years will be spent performing
human clinical trials which are defined in 4 stages:
Phase I studies are generally the first human exposure to a new
drug in healthy volunteers.
Phase II studies utilise a small number of patients.
Phase III studies have many patients recruited from around
the world.
Phase IV studies are post marketing during which further information
is collected.
In order for a drug to move from one Phase of clinical development to the next
the pharmaceutical company must seek approval from regulatory agencies such
as the FDA (Food and Drug Administration) or the EMEA (European Medicinal Products
Evaluation Agency). Approval is granted on the basis of animal safety data and,
if available, past clinical data. The animal studies required differ depending
on the clinical stage.
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