Here you will find materials that help you understand clinical studies, both for those who are choosing a site and for those who are thinking about taking part.
- Home
- Materials
Materials for sponsors, volunteers and patients
Short explanations of what a clinical study and bioequivalence are, how volunteer participation works and what a sponsor should look at when choosing a site.
Calculator: how many volunteers a bioequivalence study needs
The calculator estimates how many volunteers a standard crossover bioequivalence study (2×2) needs in its analysis, from intra-subject variability, the expected T/R ratio, power and the 80–125 % limits. The output is the number in the analysis, the number to enrol with a dropout allowance, and a power curve.
Learn more
Regulatory framework: the rules for clinical trials and bioequivalence studies in Russia and the EAEU
Clinical trials in Russia are governed by Federal Law No. 61-FZ “On the Circulation of Medicines”, the Good Clinical Practice Rules and the Bioequivalence Rules of the Eurasian Economic Union (EAEU), and orders of the Ministry of Health. This page shows what each document contains and which open registers let you check a clinic.
Learn more
Glossary of clinical trial and bioequivalence terms
Short definitions of terms found in materials on clinical trials and bioequivalence, from Cmax and AUC to informed consent and ethics review. Where a term has a legal meaning, the source is given.
Learn moreRunning clinical trials in Russia and the EAEU: an overview for sponsors
In Russia a clinical trial of a medicine needs a Ministry of Health permit, issued after an expert review of the documents and an ethics review that together take up to 25 working days. Participants must be insured, the trial follows the EAEU Good Clinical Practice Rules, and bioequivalence studies follow the EAEU Bioequivalence Rules.
Learn more
What is bioequivalence? Cmax, AUC and Tmax in plain language
Bioequivalence is the similarity in how two medicines with the same active substance enter the bloodstream. It is tested in volunteers by comparing concentration–time curves using Cmax and AUC.
Learn moreBioequivalence and therapeutic equivalence: what is the difference
Bioequivalence compares how a generic and an original medicine reach the bloodstream, usually in healthy volunteers. Therapeutic equivalence compares their clinical effect in patients. The law allows both kinds of study for generic medicines.
Learn moreEAEU rules for bioequivalence studies: a short guide
The EAEU Rules for Conducting Bioequivalence Studies (EEC Council Decision No. 85 of 3 November 2016) set the study design, the number and selection of volunteers, data analysis and the content of the report. The standard is a two-sequence crossover study, with at least 12 subjects in the analysis.
Learn more
Biowaiver: when a bioequivalence study may not be required
A biowaiver is an exemption from a bioequivalence study in people: equivalence is confirmed by a laboratory dissolution comparison if the product meets the conditions of the EAEU Rules. It does not apply to every product; where the conditions are not met, a study in volunteers is needed.
Learn more
How long does a bioequivalence study take: what the timeline consists of
The duration of a bioequivalence study is made up of stages: preparation and feasibility, permit and ethics review, volunteer recruitment, the clinical phase, bioanalysis, statistics and the report. The law limits the review to 25 working days; the rest depends on the product and the protocol.
Learn more
Phase I studies in healthy volunteers: what sponsors need to know
A phase I study is the first use of a medicine in people; healthy volunteers or patients take part, depending on the medicine. The law names safety and tolerability studies in healthy volunteers but makes an exception for medicines made outside Russia, so the admissibility of a design should be checked in advance.
Learn morePhases of clinical trials: how Phases I, II, III and IV differ
Clinical trials of a new medicine go through four phases. Phase I studies safety and dose, Phase II studies efficacy and the dosing regimen, Phase III confirms the results in a large group, and Phase IV follows the medicine after registration.
Learn more
Informed consent: what to know before you sign
Informed consent is a document you sign after a doctor has explained the study in detail: its aims, procedures, risks, benefits and your rights. Sign it only when everything is clear.
Learn more
How a volunteer is selected for a clinical study
Selection begins with a talk and informed consent. Then the doctor carries out an examination and checks whether you meet the protocol criteria. The decision is made by the study doctor on the basis of those criteria.
Learn more
How to evaluate a clinical study site: questions for sponsors and CROs
Before choosing a site, ask the clinic for documents or data on twelve points — from the right to operate and experience to the quality system, the cold chain, safety, recruitment, data handling and ethics review.
Learn more
Let us discuss your study
Tell us about the protocol and timelines — we will assess feasibility and prepare a quote.