Active substance

Active substance refers to the component of a pharmaceutical drug that is biologically active. The term is used in pharmacology, toxicology, and biochemistry. The active substance in a pharmaceutical drug is the ingredient that is responsible for the drug's therapeutic effect.

Definition

An active substance is defined as any component of a product that exerts a therapeutic effect. It is the ingredient in a pharmaceutical product that directly affects the diagnosis, cure, mitigation, treatment, or prevention of disease. In contrast, the excipients (also known as inactive ingredients) are the substances present in a drug that do not have a therapeutic effect, but serve to deliver the active substance to the body.

Classification

Active substances can be classified into several categories based on their source, chemical structure, mechanism of action, and therapeutic use. Some of the main categories include antibiotics, analgesics, antidepressants, antivirals, and vaccines.

Development and Approval

The development of a new active substance involves a series of steps including drug discovery, preclinical development, clinical trials, and regulatory approval. The Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and other regulatory authorities worldwide are responsible for the approval of new active substances.

Safety and Efficacy

The safety and efficacy of an active substance are determined through clinical trials. These trials are designed to evaluate the benefits and risks of the active substance in a controlled setting. The results of these trials are used to determine whether the active substance should be approved for use in a pharmaceutical product.

See Also

• Pharmacology
• Pharmaceutical drug
• Clinical trial
• Food and Drug Administration
• European Medicines Agency