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Main - Bioequivalence studies in Russia

Bioequivalence studies in Russia

Bioequivalence is a measure of conformity of generic drug compared with the original (branded) drug.

 

Generic (generic drug) is a copy of the original drug, that drug companies are allowed to produce and release to the market upon the expiration of a patent of the original drug .

Bioequivalence means that the reconstituted drug active ingredient is absorbed by the body with the same speed and in the same amount as the original product.

Bioequivalence study in healthy volunteers. The main criteria of bioequivalence studies are as follows: the amount and rate of absorption of the active substance, time the maximum concentration in plasma was achieved, its magnitude, distribution of the drug in the body, the method and rate of excretion of the drug. The test drug is administered in the same dosage.

 

Bioequivalence guarantees, that the same therapeutic effect is achieved after administration of generic and the original drug.

In Russia, for more than a decade, the bioequivalence study of drugs has been the main requirement of medical and biological control of generic drugs. Without data on the proven bioequivalence of generic drugs these can not proceed the state registration procedure in Russia. This provision is regulated by the Federal Law 61-Federal Law «On Circulation of Medicines".

This way there is no need for extensive and expensive clinical trial, as the effectiveness and safety of active substance is similar to the original drug.

Medical Development Agency carries out bioequivalence study rigidly in accordance with the principles and guidelines of Good Clinical Practice (GCP) and the regulatory framework of the Russian Federation. Our experts ensure high-quality and timely study process during all stages.

Bioequivalence Study includes the following stages:

1. Clinical stage is conducted by licensed and accredited clinical centers. During this stage volunteers are recruited based on the criteria for inclusion

2 . Bioanalytic stage that includes the development and validation of the methodology, study of the amount of active substance in biomaterials is conducted in specialized pharmacokinetic laboratories,.

3 . The stage of statistical and pharmacokinetic analysis , followed by the entry of data into electronic databases and their statistical treatment.

The final stage is preparation of the report based on the evaluation of statistics.

 

Our professionals have extensive experience in conducting bioequivalence study and take into account all the necessary features and nuances that help to carry out this study effectively and within time limits.

 

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