How Drugs Are Studied
How Drugs Are Studied
How Drugs Are Studied
It takes years, and sometimes decade, for a drug to move from the theoretical stage to the
pharmacy shelf. Of the thousands of drugs under investigation at any one time, only a small fraction
will produce the desired result without unacceptable side effects.
Investigation – a study
Target – to focus on
First, scientists target a step in the disease process where they believe a drug can have an effect.
Then they manufacture compounds or take them from organisms such as viruses and fungi and test
them in laboratory cultures. Once scientists isolate a chemical that produces a desired effect, they
analyse its structure and alter it as necessary to enhance the outcome.
Manufacture – to produce
Enhance – to improve
Outcome - result
The next step involves testing the drug on animals. Scientists look at how much of the drug is
absorbed into the bloodstream, how it spreads to different organs, how quickly it is excreted, or
leaves the body, and whether it has any toxic by-products. Researchers usually test at least two
animal species because the same drug may affect species differently.
Absorb – to take in
Toxic – poisonous
If a chemical passes laboratory and animal testing and is deemed appropriate to analyze in human
volunteers, it is ready for clinical trials. Researchers follow a protocol that describes who may
participate in the study, tests and procedures to follow, the length of the study, and outcomes to be
measured. Drug trials may focus on treating a disease, preventing a disease from occurring or
recurring, or enhancing the quality of life for people living with incurable, chronic conditions.
Chronic- long-lasting
There are four phases of clinical trials; the first three phases study whether the drug is effective and
can be safely administered to patients, and the fourth phase evaluates long-term safety and use
once a drug is on the market. Phase I clinical trials test several hundred volunteers to determine how
effectively the drug combats the disease being studied. These trials continue to evaluate safety, side
effects, and optimal dose. Phase II studies also last for six months to one year.
Phase III trials test thousands of volunteers for several years, with researchers closely monitoring
study participants at regular intervals. These studies typically compare the drug under investigation
with a control; either a drug known to cure or alleviate a specific disease or, if one does not exist, a
substance that has no medicinal effects, known as a placebo. Phase III trials are typically blind
studies [participants do not know which drug they are receiving] or double-blind studies [neither
participants nor researchers know which drug an individual is receiving until the trial is completed].
Once a drug passes the first three phases and is found to be safe and effective, drug companies may
apply for the right to market the product. After a drug is approved and on the market, Phase IV trials
may investigate longer-term effects, effects in different groups of patients such as the elderly, or use
of the medication for a different condition such as using a cancer drug to treat AIDS.
Substance - material