Gyógyszerértékelés

Gyógyszerértékelés, in English drug evaluation, refers to the systematic process of assessing the safety, efficacy, and quality of a medicinal product before it can be approved for use. This evaluation is a critical step in the drug development lifecycle, ensuring that new treatments meet rigorous standards before they become available to patients. The process typically involves multiple stages, beginning with preclinical studies conducted in laboratories and on animals. These studies aim to understand the drug's pharmacological properties, potential toxicity, and how it is absorbed, distributed, metabolized, and excreted by the body.

Following successful preclinical testing, drugs proceed to clinical trials in humans. These trials are divided into several phases. Phase I trials, involving a small group of healthy volunteers, focus on safety, dosage, and side effects. Phase II trials, conducted on a larger group of patients with the target condition, assess the drug's effectiveness and further evaluate safety. Phase III trials, the largest and most comprehensive, confirm efficacy, monitor side effects, compare the drug to standard treatments, and collect information that will allow the drug to be used safely.

Regulatory agencies, such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA), are responsible for reviewing the data gathered during preclinical and clinical studies. They assess the benefit-risk profile of the drug, weighing its therapeutic advantages against any potential harms. If the drug is deemed safe and effective for its intended use, it receives marketing authorization. Post-market surveillance, also known as Phase IV trials, continues to monitor the drug's safety and effectiveness once it is available to the public. This ongoing evaluation helps identify rare side effects or long-term issues that may not have been apparent during the initial testing phases.