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Before a drug is approved, it must go through rigorous testing to determine if it is safe and effective.
From the laboratory to your medicine cabinet — the process of researching and developing a drug is long, complicated and costly. It takes an average of 10 years and more than $2 billion to bring new medications and therapies to market. Less than 15% of all the drugs in development make it through to patients.
The idea for a potential new treatment typically begins from basic science research. Basic science an area of medical research that seeks to understand broadly how and why our bodies do what they do, and how and why a disease such as eczema starts, develops and evolves.
From these findings, scientists may identify a compound (early stage drug) that they believe will help stop a particular symptom or symptoms of a disease. This begins the pre-clinical stage of drug development whereby researchers look at how the drug may work in the body (mechanism of action), dosage, side effects, and effectiveness of the drug. Not all compounds begin from basic research, scientists may get ideas through looking at existing drugs that have unintended effects and results from new technologies, among others.
If the findings from this pre-clinical research offer promising data on the compound, scientists then move into phase I of clinical trials. In order to begin clinical trials, researchers must apply to the Food and Drug Administration (FDA) to show that the study meets minimum FDA research requirements.
Depending on the outcomes of the prior phase of research, the study moves to the next phase of the clinical trial process, testing the compound on larger and more diverse groups of people. In each phase, researchers are gathering information on how safe and effective the drug is for its potential use.
At the end of phase III, researchers file a New Drug Application (NDA) with the FDA. The NDA compiles all the research done on the drug to date for the FDA to review. From this NDA, the FDA either approves the treatment for widespread use, denies the drug, or requests additional information in order to make an informed decision.