Who Can Participate in Bioequivalence Studies
Healthy adult volunteers can participate in bioequivalence studies. In order to participate in a bioequivalence study, you must meet specific criteria, such as:
However, each study has a specific group of criteria which define who is eligible to participate.
Your own eligibility can be defined by various factors, depending on the nature of the study. If you meet the eligibility criteria, you will be given a consent form containing a detailed written description of all the stages of the study, any potential risks, and your rights as a participant. If the procedure includes any type of intervention for example, drawing a blood sample or personal data relating to your health, the process of granting consent will be performed prior to the eligibility screening to ensure that you have been informed of what will be asked of you and of any potential risks. By signing and returning the consent form, you agree to participate in the study. If you have doubts regarding your participation or do not feel comfortable during the study, you have the right to withdraw at any time, without any consequences.
There is no direct therapeutic benefit to you through your participation in bioequivalence studies. These studies will help confirm that the generic drug meets the necessary specifications needed to allow approval for its launch.
You will not bear the cost of any physical, laboratory, or other test. Moreover, after the conclusion of the study, you will receive a reasonable compensation for the time you have devoted to the study.