There are many prescription drugs on the market to treat everything from common infections to diabetes and high blood pressure. People pick up their prescriptions at pharmacies across the country everyday without giving much thought to how the drugs became available. In reality, drug development is a long and complicated process that often takes years and can cost billions of dollars. Continue reading to learn more about how a prescription drugs start as an idea and eventually land on pharmacy shelves:
Research and Development
The first step in drug development is a lot of research in a laboratory. Researchers consider new technology, existing treatments that have unanticipated effects that may treat other diseases, and new information in regards to disease processes when considering different compounds that may eventually become a new prescription drug. When something promising is found, experiments are run on the compounds, typically at the molecular level.
In the event that researchers find a new compound that shows a lot of promise, the development phase begins. Additional experiments are then done to discover how a compound is absorbed and metabolized, the correct dosage, potential side effects, how the compound may react with other drugs, and how effective a compound may be for a specific disease.
A lot of work goes into the research and development phase, but a drug needs to be tested to see what happens. A number of experiments may be done in test tubes before the compound is tested in living animals, such as mice. These experiments tell the researchers a lot about how safe a compound is. Copious notes are taken during the pre-clinical research stage; at the end of a pre-clinical trial, all of the information is analyzed to determine if the compound is safe enough to test on people.
Clinical trials are one of the most important phases of drug development. During this phase, the compound/ new prescription drug is tested in humans. The first clinical trial is typically small. If the drug works well and the trial is considered successful, several more clinical trials will be done, each one bigger than the last. Information from each clinical trial is carefully recorded and detailed reports are written.
This information is then used when filling out an application for approval from the Food and Drug Administration. In some cases, a new drug will have problems during the clinical trials and the company developing the drug will have to start all over. Contact a company, like Drug Development Consultants, for more help.