Võrdlusravimite

Võrdlusravimite, often translated as comparative medicines or reference drugs, are a crucial component in the process of drug development and regulatory approval. They are established, approved medications that a new drug candidate is compared against during clinical trials. The primary purpose of using a võrdlusravim is to demonstrate the safety and efficacy of the new drug relative to existing treatments.

In clinical trials, patients are typically divided into groups. One group receives the new drug, while another group receives the võrdlusravim. Sometimes, a third group might receive a placebo, which is an inactive substance, to establish a baseline. Researchers then meticulously measure and compare various outcomes, such as symptom improvement, disease progression, side effects, and survival rates, between the groups.

The selection of an appropriate võrdlusravim is a critical decision. It should be a medication that is widely used and recognized as effective for the condition being treated. The regulatory authorities, such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA), often provide guidance on which comparator drugs are acceptable for specific therapeutic areas.

Demonstrating superiority, non-inferiority, or bioequivalence to a võrdlusravim is essential for a new drug to gain marketing authorization. Superiority means the new drug is significantly better than the comparator. Non-inferiority means the new drug is not significantly worse, suggesting it offers comparable benefits with potentially fewer side effects or a more convenient dosing schedule. Bioequivalence means the new drug is absorbed into the bloodstream at the same rate and to the same extent as the comparator drug. The results of these comparative studies form the basis for regulatory decisions about whether a new medicine can be made available to patients.