https://bessalar.ru/en/materials/ Articles on clinical trials, bioequivalence and their regulation in Russia and the EAEU. en Wed, 21 Oct 2026 00:00:00 GMT https://bessalar.ru/en/materials/bioequivalence-cmax-auc/ https://bessalar.ru/en/materials/bioequivalence-cmax-auc/ Wed, 21 Oct 2026 00:00:00 GMT Science 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. https://bessalar.ru/en/materials/bioequivalence-study-timeline/ https://bessalar.ru/en/materials/bioequivalence-study-timeline/ Wed, 21 Oct 2026 00:00:00 GMT For sponsors 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. https://bessalar.ru/en/materials/bioequivalence-vs-therapeutic-equivalence/ https://bessalar.ru/en/materials/bioequivalence-vs-therapeutic-equivalence/ Wed, 21 Oct 2026 00:00:00 GMT Science 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. https://bessalar.ru/en/materials/biowaiver/ https://bessalar.ru/en/materials/biowaiver/ Wed, 21 Oct 2026 00:00:00 GMT Regulation 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. https://bessalar.ru/en/materials/choosing-a-clinical-site/ https://bessalar.ru/en/materials/choosing-a-clinical-site/ Wed, 21 Oct 2026 00:00:00 GMT For sponsors 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. https://bessalar.ru/en/materials/clinical-trial-phases/ https://bessalar.ru/en/materials/clinical-trial-phases/ Wed, 21 Oct 2026 00:00:00 GMT Science 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. https://bessalar.ru/en/materials/clinical-trials-in-russia-eaeu/ https://bessalar.ru/en/materials/clinical-trials-in-russia-eaeu/ Wed, 21 Oct 2026 00:00:00 GMT Regulation 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. https://bessalar.ru/en/materials/eaeu-bioequivalence-rules/ https://bessalar.ru/en/materials/eaeu-bioequivalence-rules/ Wed, 21 Oct 2026 00:00:00 GMT Regulation 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. https://bessalar.ru/en/materials/informed-consent/ https://bessalar.ru/en/materials/informed-consent/ Wed, 21 Oct 2026 00:00:00 GMT For volunteers 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. https://bessalar.ru/en/materials/phase-1-healthy-volunteers/ https://bessalar.ru/en/materials/phase-1-healthy-volunteers/ Wed, 21 Oct 2026 00:00:00 GMT Regulation 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. https://bessalar.ru/en/materials/volunteer-screening/ https://bessalar.ru/en/materials/volunteer-screening/ Wed, 21 Oct 2026 00:00:00 GMT For volunteers 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.