referenciagyógyszer

A referenciagyógyszer, also known as a reference drug or comparator drug, is a medication used in clinical trials to compare the efficacy and safety of a new investigational drug. It is typically a well-established drug with a known therapeutic profile that is already approved for treating the condition being studied. The purpose of using a referenciagyógyszer is to provide a benchmark against which the new drug's performance can be objectively assessed.

When designing a clinical trial, researchers select a referenciagyógyszer that represents the current standard of care for the target disease or condition. This allows for a direct comparison of how the investigational drug performs relative to existing treatments. The trial will then investigate whether the new drug is superior, non-inferior, or equivalent to the referenciagyógyszer. This comparison is crucial for determining the potential benefit and place of the new drug in clinical practice.

The selection of a referenciagyógyszer is a critical step in trial design and is often guided by regulatory agencies and expert consensus. The chosen drug must be relevant to the patient population being studied and possess a well-documented efficacy and safety profile. Data from trials using a referenciagyógyszer are essential for regulatory submissions and for informing healthcare professionals and patients about the potential advantages and disadvantages of the new treatment.