Market share of original medicines in Russia is incredibly small because of great costs of drug development, pre-clinical and clinical trials of an original drug. Large part of an original medicine cost consists of development and marketing expenses. That’s why many companies in CIS are specialized on production of drugs after the patents on the original ones expires. Such generic drugs are more available for population because their price doesn’t include the cost of drug development and extensive clinical trials. However, generics must have the same quality, safety and efficiency as the original medicines. To approve it company conducts bioequivalence studies.
There are several types of equivalence:
- Pharmacokinetic (bioequivalence);
This article is about understanding pharmacokinetic studies. Bioequivalence shows in vivo experimental similarity of a pharmaceutically equivalent drug (generic) to the reference one (original). These are main measurement of bioequivalence:
- Degree and rate of absorption of the drug;
- Time of reaching a maximum concentration in blood and its value;
- The nature of the distribution of the drug in tissues and body fluids;
- Type and speed of drug excretion.
Sometimes terms of bioequivalence and bioavailability are confused, so it’s important to define the difference between them. Bioavailability shows how substance enters the systemic circulation from the dosage form. Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives, and their bioavailability, in terms of rate and extent of absorption, after administration of the same molar dose under the same conditions, are similar to such a degree that their effects can be expected to be essentially the same.
Such brief description is enough to understand what bioequivalence is and what are main parameters for comparing drugs generally. If you need deeper understanding of this topic for your project our professional team with an incredible experience of conducting bioequivalence studies will answer your proposal as soon as possible.