Lääkelaitteista

Lääkelaitteista, known in English as medicinal products or pharmaceuticals, are substances or combinations of substances intended for treating or preventing diseases in humans or animals. They can also be used to diagnose diseases or to restore, correct, or modify physiological functions by exerting a pharmacological, immunological, or metabolic action. The development and regulation of medicinal products are crucial for public health and safety.

In many countries, a specific regulatory authority oversees the authorization, marketing, and post-market surveillance of medicinal products. This process typically involves rigorous testing for efficacy, safety, and quality before a product can be made available to the public. Clinical trials, conducted in phases, are a fundamental part of demonstrating a product's benefit-risk profile.

Medicinal products come in various forms, including tablets, capsules, injections, creams, and inhalers. They can be classified based on their intended use, such as antibiotics for bacterial infections, analgesics for pain relief, or vaccines for disease prevention. Some medicinal products require a prescription from a healthcare professional, while others are available over-the-counter.

The active pharmaceutical ingredient (API) is the component of a medicinal product responsible for its therapeutic effect. The excipients are inactive ingredients that help in the formulation, delivery, and stability of the API. Pharmacovigilance, the ongoing monitoring of the safety of medicinal products once they are on the market, is essential to identify and assess any adverse reactions that may not have been apparent during clinical trials. This continuous monitoring ensures that the benefit-risk balance of medicinal products remains favorable throughout their lifecycle.