1. What is a bioequivalence study?
Biological equivalence (bioequivalence) means chemical-pharmaceutical equivalence and identical bioavailability between two pharmaceutical products.
Two pharmaceutical products containing chemically equivalent active substances are considered bioequivalent, if administered to the same person, in the same posology, they achieve equivalent plasmatic and tissue concentrations. Basically, two pharmaceutical products, with identical active substance are bioequivalent, thus substitutable for the pacient without involving any risc, if the bioavailability between them is not significantly different (<5%).
Bioequivalence studies are aimed to demonstrate these similarities between an originator medicine and a generic medicine, by comparing pharmacokinetic and pharmacodynamic parameters. Pharmacokinetic parameters are determined by taking biological samples (blood, urine) from the volunteers at well determined time intervals, and measuring the amount of drug (or metabolites) in these samples.
2. How does a bioequivalence study take place?
Bioequivalence studies are usually carried out in two distinct stages. During the first stage, the volunteers are treated with either the investigational medicinal product or the reference medicinal product. In the second stage the volunteers are treated with the alternative medicinal product. Between the two periods there is a washout period of a few days or weeks, depending on the requirements of the respective study. Before beginning a bioequivalence study, a number of prospective volunteers are evaluated, this selection is called a "screening".
3. What is a phase I study?
Phase I studies are clinical studies conducted to determine the pharmacokinetic and pharmacodynamic profile of a new active substance, as well as its safety and tolerability profile. These information make it possible to determine the dose that should be used in later trials.
4. How does a phase I study take place?
Phase I studies are usually conducted in a small group of healthy volunteers, who receive a well determined dose of a new medicine. The initial dose is determined based on preclinical studies on animals, extrapolated for humans. This initial dose is then sequentially increased, until a limiting toxicity occurs. This dose is called the Maximum Tolerated Dose (MTD).
5. Subjects participating in clinical studies are guinea pigs?
NO. The participation in such studies is voluntary. Individuals interested receive guidance about the trials, as well as information about the risks and adverse events associated to the drugs being tested. Only after these clarifications does the person choose to participate or not.
The volunteer is not forced, at any time, to participate in the study. The volunteer can withdraw at any phase of the study.
6. Who has the right to conduct clinical studies?
Clinical studies may be carried out only by clinical centers authorized and accredited for this activity. All clinical centers that carry out such studies, must have an authorization from the Ministry of Health and from the National Agency for Medicines and Medicinal Devices. Clinical centers that wish to conduct clinical trials must also obtain a certificate of Good Clinical Practice (GCP), and a certificate for Good Laboratory Practice (GLP).
7. Who can become a volunteer?
Volunteers in clinical studies must be healthy individuals, both men or women, between 18 and 45 years, non-smokers, with compatible weight and height, who do not take other medicines, with no history of drug or alcohol abuse.
8. How can you participate as a volunteer in a bioequivalence study?
To become a volunteer, you must fill out the Questionnaire for volunteers. Data submitted through this questionnaire are stored in our database, out of which volunteers are chosen for clinical studies.
Once your file is complete, our recruiting executive will identify a study that perfectly matches your profile and availability. They will then book an appointment for a general informational meeting about a certain study, where an "Informed Consent Form" is signed and a medical examination is carried out. You will see a physician, who will assess your health by giving a general examination: measuring your weight, height and body frame, performing urine test, taking blood sample, and electrocardiogram. By going through all this, we wish to assure both you and ourselves that we will not endanger your health in any way. We also wish to make sure that nothing about your physical condition will distort the results of the study in which you may be asked to participate. If the results of your medical examination are satisfactory, one of our recruiting executives will get in touch with you, to confirm your participation in a given study. Helping volunteers to participate is essential to our success, so we will do everything possible to pave the way for your participation.
9. What are the obligations of a volunteer?
Before every study, volunteers are informed about general obligations and study specific obligations. Usually, clinical studies require the volunteers to be admitted in the clinical center for the duration of the study. During this time volunteers can leave the unit only on their own responsibility, being automatically excluded from the study. During the study volunteers must respect the rules of the clinical center and the specific rules of the study. Smoking, alcohol and/or drug consumption and intense physical effort is forbidden during the studies. Volunteers cannot receive visitors during the study, and have to consume only the fluids and food received from the staff.
10. What are the advantages of participating in a bioequivalence study?
Our Center shall pay you a remuneration for the inconvenience caused to you as a participant in a study.
Besides, you are doing a social service of the highest quality by participating in a study, because only after these medicines are proved as per their claimed safety and efficacy will they get the permission to be marketed. This way, you help quality medicines get to the patients who need them.