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Whenever your doctor has prescribed medicine or you have bought an over-the-counter cold and flu remedy, you probably have not thought much about how the medicine was developed—you are mostly interested in feeling better. Although a pill may quickly make your aches or sniffles go away, it probably took scientists years to bring together the right combination of elements to design that pill. And it took many more years to prove, through extensive testing, that the pill was safe and effective. Bringing a new drug onto the market requires about 10 to 15 years and can cost more than $1.3 million. Because of this time and expense, and because of the powerful effect that drugs have on the body, pharmaceutical companies employ many different kinds of professionals to develop new products. Lab technicians, scientists, writers, researchers, pharmacists, medical doctors, and others work together throughout the development process. Because of all the different stages of drug research and development, these professionals hold degrees in a number of different areas, including biology, chemistry, engineering, biochemistry, pharmaceutical technology, life science, and biotechnology.
Scientists and business executives work together to come up with ideas for new drugs. Some drug companies focus their efforts on particular remedies. While one company may develop drugs to treat visual problems, another company may develop drugs for skin ailments. Biologists, chemists, engineers, and other scientists then develop these drugs, with the aid of lab assistants, pharmacists, and information professionals. Whatever the company's focus, the product must be approved by the FDA. Only about one in every 5,000 to 10,000 active ingredients ever reach this stage.
Once a pharmaceutical company has identified a drug for development, scientists make work plans and project proposals. This involves designing experiments, planning work schedules, and researching scientific records. Within the research and development department of a drug manufacturer, scientists use the principles of biology and chemistry to work with compounds in the production of new drugs. These scientists must have an understanding of the disease that the drug is to treat and the relationship between the chemical and biological compounds under study. They collect information from private and public databases. They determine the best ways to combine the compounds. They organize and maintain lab equipment, supervise development teams, conduct tests, evaluate data, and maintain records. To meet FDA approval, a drug is rigorously tested by pharmacologists, pharmakineticists, toxicologists, and other scientists to determine the drug's effect on the body. After years of testing, the drug can be administered to volunteers in clinical studies, with the aid of medical doctors.
Throughout the research and development process, information professionals conduct research on similar drugs, the marketplace, and the cost of bringing the drug to the market. They compile information from libraries, computer databases, and the Internet.