Bioequivalence (pharmacokinetic equivalence) is the degree of similarity of a pharmaceutically equivalent drug to a reference drug (usually a generic drug to an original proprietary drug). Determined experimentally, in vivo.
As you know, after the development and registration (authorization) of a medicinal product, the product enters the pharmaceutical market. The developer is the owner of the patent rights for the developed and approved products. But, as a rule, in the absence of competition, the manufacturer sets a price for original medicines, which it considers reasonable without giving any reasons. This is where the question arises of reconstructing a drug with the same properties, qualitative and quantitative composition, but without violating patent rights. Such drugs are called “generic drugs”, i.e. reproducible drugs. And the original drug or pharmaceutical substance is called the reference. Generics can significantly expand the range of medicines and reduce their cost. But the efficacy and safety of a reproducible drug must be proven.
Bioequivalence studies are conducted to prove the similarity of the generic to the referent. Bioequivalence studies are a part of clinical trials conducted with human participants for the purpose of the comparative study of the pharmacological properties (pharmacokinetics, pharmacodynamics, toxicity, etc.) of a generic and a reference drug.
Bioequivalence studies can be carried out by organizations that have all the necessary bases and specialized conditions for the implementation of this type of work. These include educational institutions of higher education, research centers, accredited laboratories. The National Scientific Center of Pharmacovigilance can also conduct these studies (clinical trials), you can familiarize yourself with the range of our services here
All work in relation to drug research must be carried out in strict accordance with state legislation and accepted international standards. For more information on the National Standard of the Russian Federation for Research on Bioequivalence of Medicinal Products, see the attached document