referenssilääke

A referenssilääke, often translated as reference medicine or reference drug, is a specific pharmaceutical product designated for use in comparative clinical trials. Its primary purpose is to serve as a benchmark against which the efficacy and safety of a new drug candidate are evaluated. This established product is typically a well-known and widely used medication for the condition being studied.

The selection of a referenssilääke is a critical step in drug development. It must be chosen carefully to ensure that the comparison is meaningful and scientifically sound. Factors such as its known therapeutic profile, established dosage regimens, and availability in the relevant market are taken into consideration.

In clinical trials, participants are often randomly assigned to receive either the new drug or the referenssilääke. Researchers then collect data on various outcomes, such as symptom improvement, side effects, and survival rates, to determine if the new drug offers any advantages, such as being more effective, having fewer side effects, or being easier to administer. The results of these comparisons help regulatory authorities decide whether to approve the new drug for marketing. The term referenssilääke emphasizes its role as a standard for measurement and evaluation in the pharmaceutical research process.