Slow procedure

It takes 15 years on average for a drug discovery to make it to a patient’s medicine cabinet. Throughout the process, the U.S. Food and Drug Administration requires drug companies to submit applications to proceed to the next step.

1 Drug discovery and preclinical research (three to six years) – Researchers search for candidate drugs by screening chemical compounds that contain thousands or millions of potential medicines. They test the candidates against the disease target.

Once a compound has shown some activity against the drug target, it undergoes extensive testing in the lab – both in test tubes and animals. Years of preclinical testing must establish that the candidate medicine is likely to be safe and effective in humans before clinical testing can begin.

2 Clinical trials (six to seven years) – When a company is ready to begin clinical trials, it submits an Investigational New Drug Application to the FDA showing the data it has gathered in preclinical tests, as well as a clinical studies plan or protocol. Testing occurs in three phases:

Phase 1 – A small group of healthy people is tested to see how the chemical compound affects the body.

Phase 2 – The drug is tested in patients who have the disease in question.

Phase 3 – The drug is tested in hundreds or thousands of patients to find any rare or adverse side effects.

3 FDA review and manufacturing (two years) – Upon successful completion of clinical trials, the company submits a New Drug Application to the FDA.

Teams of engineers, biologists, chemists and physicists work to develop ways to produce the medicine on a large scale.

SOURCE: Pharmaceutical Research and Manufacturers of America

Source: Dallasnews.com