What bioequivalence is
A generic medicine contains the same active substance as an earlier medicine from another manufacturer. It is produced once the original medicine’s patent term has ended. Bioequivalence studies are carried out to prove that the generic medicine is equivalent to the reference medicine.
In a typical study, each volunteer takes both medicines in different periods (a crossover design). Blood samples are taken at strictly set times, and the concentration of the active substance is measured. The concentration–time curves of the two medicines are compared by key parameters: Cmax and AUC.
What we offer
- Conduct of the study according to the protocol and in line with the principles of Good Clinical Practice (GCP).
- Our own volunteer database; we assess realistic enrolment rates for your protocol at the feasibility assessment stage.
- On-site pre-analytical processing of samples: centrifuges, freezers (from −20 to −80 °C) and refrigerated cabinets.
- An in-patient unit with round-the-clock medical supervision and a security post and an intensive care ward.
- Qualified staff: the clinic’s physicians hold valid specialist certificates and GCP certificates.
How a study is conducted
- Protocol assessment. We check the inclusion criteria, the sampling schedule and realistic enrolment timelines — see feasibility assessment.
- Documents and ethics review. We prepare the study documents; the local ethics committee reviews the package.
- Volunteer selection. Physicians examine candidates and check that they meet the criteria of the protocol; the participant signs informed consent.
- Admission to the in-patient unit and sampling. Volunteers stay in the clinic’s in-patient unit during the study periods; samples are taken and processed according to the protocol.
- Transfer of samples and data. The clinic carries out the clinical part and the pre-analytical processing of samples; the samples and data are then passed to the sponsor or the contract research organisation (CRO).
What we need for a quote
Send us a synopsis or protocol, information on the medicines (test and reference), the planned number of volunteers and your target timelines. We will assess feasibility and come back with a budget and a schedule. Send us a request or call us.
Regulatory basis
In the EAEU countries, bioequivalence studies are conducted under the Rules for Conducting Bioequivalence Studies (Decision of the Council of the Eurasian Economic Commission of 3 November 2016 No. 85, as amended in 2020, 2023 and 2024) and the EAEU Rules of Good Clinical Practice (Council Decision of 3 November 2016 No. 79, as restated by Decision No. 63 of 1 August 2025, in force since 10 March 2026).
Questions and answers
What is a generic medicine, and why prove bioequivalence?
A generic medicine contains the same active substance as a medicine created earlier. It is produced once the original medicine’s patent protection has ended. A bioequivalence study is carried out to show that the generic medicine is equivalent to the reference medicine.
Which parameters are compared in a study?
From the concentration–time curve, the main parameters compared are Cmax (the maximum concentration of the active substance in the blood) and AUC (the area under the curve, that is, the total amount of the substance that has entered the bloodstream).
Who takes part in bioequivalence studies?
As a rule, healthy volunteers who meet the criteria of the protocol. The clinic’s physicians select and examine them before they are enrolled in the study.
See also
Phase I clinical trials in Moscow
Phase I is the first use of a new medicine in humans. It studies safety, tolerability and how the medicine behaves in the body, and helps to find a suitable dose. A small group of healthy volunteers or patients usually takes part.
Learn more
Feasibility assessment of a clinical study
A feasibility assessment is a review of the protocol before a study starts. It shows whether the study can be run at the site within the required timelines and with the required number of participants. The clinic carries out this assessment for sponsors and contract research organisations (CROs).
Learn more
Equipment for clinical studies
The clinic has equipment for monitoring participants, emergency care and pre-analytical processing of samples, from 12-lead ECG recorders and bedside monitors to centrifuges and freezers.
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