Drug To Pharmaceutical

Why does it take so long to bring a pharmaceutical to market? The answer in the United States is in the process. In the US, we require all new potential medications to go through a very rigorous process prior to being allowed to be on our market. To take a new chemical, drug, compound from the discovery stage to your pharmacy, pharmaceutical companies must register it with the Food and Drug Administration (FDA) as an Investigational New Drug (IND) and then progress the compound through a series of stages: Phase I, Phase II, and Phase III. The three stages of development are designed to provide a controlled and safe framework for assessing how a compound works before it is released in the market. Before a compound can move from one phase of development to another, the investigational new drug must meet or exceed its expected outcomes.  Phase I is usually designed to determine if the drug compound has the anticipated effects in a model setting that simulates how a human body may react to that given compound. If successful in Phase I testing, the drug compound then moves on to Phase II, at which point it generally is tested for safety in humans.  Phase II testing may include some efficacy testing to determine if the compound has the desired effect, but generally it is designed to look at how the human body reacts to the compound. Finally, in Phase III, the drug is tested in tightly controlled large trials that give the company and the US FDA a strong idea of how the compound works against the target disease or condition in a real world clinical setting. If all of these phases are successful it is then reviewed by the US FDA and may receive authorization to market the product. Once released to the market, the compound is now better described as a pharmaceutical.