Introduction
The journey of a compound becoming a drug in the United States is a long and complex process that involves many stages and several regulatory agencies. The process begins with the discovery of a new compound and ends with the approval and marketing of a new drug. In this blog post, we will take a closer look at the various stages and steps involved in this process and discuss how active ingredients are tested, developed, and ultimately approved for use as drugs in the United States.
Discovery of a New Compound
The first step in the process of a compound becoming a drug is the discovery of a new compound. This can happen in several ways. Scientists may discover a new compound through research in academic or government laboratories, or through research and development efforts by pharmaceutical companies. The compound may be discovered through screening of natural products, through synthetic chemistry, or through biotechnology methods such as genetic engineering.
Preclinical Testing
Once a new compound is discovered, it enters the preclinical testing stage. During this stage, scientists conduct laboratory and animal studies to determine the compound’s safety and efficacy. The scientists also study the compound’s pharmacokinetics, which is how the body absorbs, distributes, metabolizes, and excretes the compound. They also evaluate the compound’s toxicity, which is the potential harm it may cause to the body.
Investigational New Drug Application
After the preclinical testing stage is complete, the next step is the Investigational New Drug (IND) application. The IND application is a request to the Food and Drug Administration (FDA) for permission to conduct clinical trials on humans. The IND application includes information about the compound’s safety and efficacy, as well as information about the proposed clinical trials. The FDA reviews the IND application and, if it is approved, the compound can move on to the next stage: human clinical trials.
Human Clinical Trials
Human clinical trials are the next step in the process of a compound becoming a drug. These trials are conducted to evaluate the safety and efficacy of the compound in humans. The trials are conducted in three phases: Phase I, Phase II, and Phase III.
Phase I trials are the first time that the compound is tested in humans. They are conducted on a small number of healthy volunteers to determine the compound’s safety, dosage, and side effects.
Phase II trials are conducted on a larger number of people, typically several hundred to several thousand patients, to further evaluate the compound’s safety and efficacy.
Phase III trials are conducted on a large number of patients, typically several thousand, to confirm the compound’s safety and efficacy and to compare it to other drugs already on the market.
New Drug Application
After the human clinical trials are complete, the next step is the New Drug Application (NDA). The NDA is a request to the FDA for approval to market the drug. The NDA includes information about the compound’s safety and efficacy, as well as information about the proposed labeling and packaging of the drug. The FDA reviews the NDA and, if it is approved, the drug can be marketed and sold in the United States.
Conclusion
The process of a compound becoming a drug in the United States is a long and complex process that involves many stages and several regulatory agencies. It starts with the discovery of a new compound and ends with the approval and marketing of a new drug. The process includes preclinical testing, an Investigational New Drug application, human clinical trials, and a New Drug Application. The FDA reviews the IND and NDA applications and, if they are approved, the compound can be marketed and sold as a drug in the United States