Drug Discovery & Development

Drug discovery is a process, which aims at identifying a compound therapeutically useful in treating and curing a disease. Typically a drug discovery effort addresses a biological target that has been shown to play a role in the development of the disease or starts from a molecule with interesting biological activities. Each year many new prescription drugs are approved by the Food and Drug Administration (FDA). The process of developing and bringing new drugs to market is important for primary care physicians to understand. A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The process starts with preclinical testing. For drugs that appear safe, an investigational new drug application is filed with the FDA. If approved, clinical trials begin with phase 1 study that focus on safety and pharmacology. Phase 2 studies examine the effectiveness of the compound. Phase 3 is the final step before submitting a new drug application (NDA) to the FDA. An NDA contains all the information obtained during all phases of testing. Phase 4 studies, or post marketing studies, are conducted after a product is approved. Recent changes in legislation have streamlined the approval process. Critics contend that these changes have compromised public safety, resulting in the need to recall several products from the market. Proponents claim that changes in the approval process help patients with debilitating diseases, such as acquired immunodeficiency syndrome, that were previously denied critical medication because of bureaucratic regulations