Pharmaceuticals have been around since early 2000 B.C. Since then, the drug market and its vendors have definitely skyrocketed. Pharmaceuticals are regulated by the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and steps are required to bring new drugs into the market. FDA specific guidelines for new pharmaceuticals are essential because it determines a drug’s safety and effectiveness. To support this thesis an overview of steps required to market a new pharmaceutical will be discussed as well as human testing of drugs, the role of FDA in approving new drugs, and the cost incurred by drug companies when developing new drugs.
Pharmaceutical development can be divided into segments. The first segment is the preclinical phase; this is where the drug company attempts to breakdown a disease process into components so it can provide clues for targeting new drug development and usually takes three to four years to complete (Lipsky & Sharp, 2001). Once a new drug has been chosen and developed, the FDA requires that animal tests be performed. In vivo testing, typically done to rodents, demonstrates the safety of the prospective medication and also to notes and evaluates any side or toxic effects, addictions, cancerous tumors, and/or fetal deformities (Turley, 2010, p. 27). The results from the animal studies, indicating no risk to humans, will then be used to support the investigational new drug application (IND) to the FDA to request permission to test the drug in humans (Turley, 2010, p. 28). If the FDA is approves the application and documentation, the stage is set for clinical trial phases of human testing.
Clinical trials of human testing are branched out into three phases. Once IND applications are approved, the drug company can transport the drug to clinical investors at various clinical sites so clinical trials can begin and