Approved drug

Approved Drug refers to a pharmaceutical drug that has received approval from a drug regulatory authority such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, or other similar bodies in various countries. The approval signifies that the drug has undergone rigorous clinical trials and has been found to be safe and effective for its intended use.

Overview

The process of drug approval involves several stages, starting from the drug discovery and development phase, followed by preclinical research, clinical trials, and finally, review by the regulatory authority. Only after a drug has successfully passed through all these stages can it be considered an approved drug.

Drug Discovery and Development

The initial stage in the creation of an approved drug is drug discovery and development. This involves identifying potential active pharmaceutical ingredients (APIs) that may have therapeutic effects. Once a potential API is identified, it undergoes further development to optimize its properties, such as its efficacy, safety, and delivery method.

Preclinical Research

Before a drug can be tested in humans, it must undergo preclinical research. This involves testing the drug in the laboratory and in animals to evaluate its safety and efficacy. The results of these tests are used to determine whether the drug should proceed to clinical trials.

Clinical Trials

Clinical trials are conducted in several phases. Phase I trials involve a small group of healthy volunteers and aim to evaluate the drug's safety, dosage, and side effects. Phase II trials involve a larger group of patients and aim to evaluate the drug's efficacy and side effects. Phase III trials involve a large group of patients and aim to confirm the drug's efficacy, monitor its side effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely.

Review by Regulatory Authority

Once a drug has successfully completed clinical trials, the data is submitted to a drug regulatory authority for review. The authority evaluates the data to determine whether the drug is safe and effective for its intended use. If the authority is satisfied with the data, it grants approval for the drug to be marketed and used in the population.

Post-Marketing Surveillance

Even after a drug has been approved, it continues to be monitored through post-marketing surveillance. This allows for the detection of any adverse effects that may not have been apparent in the clinical trials.