What is bioequivalence
It is known that a lot of the drugs sold in Russia are not original drugs, but their reproducible counterparts, which is due to much lower costs for the organization of production and market entry in comparison with the original, new drugs. Big pharmaceutical companies are investing heavily in the development of new medicines. This is one of the main reasons for the high price of drugs. However, there are companies that specialize in the generics production. Generics are more accessible to different segments of the population, due to the fact that the cost of developing the drug and its broad clinical studies are not included in their price. However, in this case, generics must accord the same standards of quality, efficacy, and safety as are required for original medicines. To comply with all the above standards, it is necessary to conduct a bioequivalence study.
There are the following types of equivalence:
- pharmacokinetic (bioequivalence),
The focus of this article is the bioequivalence study. Bioequivalence is the degree of similarity of a pharmaceutically equivalent drug to a reference drug (usually a generic to an original drug). It is determined experimentally, in vivo. The main criteria for bioequivalence are:
- the degree and rate of the drug absorption,
- time to reach the maximum concentration in the blood and its value,
- the nature of drug distribution in tissues and body fluids,
- type and rate of the drug withdrawal.
Sometimes the concepts of bioequivalence and bioavailability are confused, so it is worthwhile to clearly distinguish between these terms. Bioavailability is a subcategory of absorption and is the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. According to the definition of WHO, two drugs are considered bioequivalent, if they are pharmaceutically equivalent, have the same bioavailability and when used in the same dose ensure proper efficacy and safety.
In the most compressed form, this information is sufficient to understand what bioequivalence is, why it is needed, and what parameters of drugs are taken into account when comparing drugs. However, for a deeper understanding of this topic, it is necessary to answer several other questions, such as: on the basis of what mathematical and statistical conclusions is the decision about the bioequivalence of drugs taken? Who participates in such trial? Who is the object of such trial? What basic documents are needed to conduct such trial? What methods are used in these studies? Finally, who conducts such studies? On these and on many more questions you can find answers in our next articles.
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