Development of a program
for the study of bioequivalence

Getting permission for
clinical trial

Receiving an import authorization
 of an unregistered medicinal product

Selection of clinical and analytical
databases for research

Organization of insurance
of volunteers participating in the study

Conclusion of contracts with performers,
passage of Local Ethical Expertise

Monitoring of the research
at all stages of its conduct

Statistical analysis,
preparation of the Clinical Research Report

 

Most of the new drugs that appear on the Russian market do not refer to the original pharmaceutical products, but to the so-called reproduced drugs. Such drugs are called generics. These are, in most cases, medicines, which include components that are not protected by the patent or the expired time of the validity of the existing patent.

Analogues with their medicinal properties differ little from medicines-"originals", but have a lower cost. This is the reason why WHO provides the maximum possible support for the manufacture of analogues and their use instead of "original" drugs to provide cheaper access to medicine around the world.


In the Russian Federation, a lot of medicines are registered each year, among which most of it is taken by generics. To ensure the proper level of medical care, these drugs should be of the same quality as the "originals". And these same requirements are imposed on the effectiveness of medicines and safety.


The state registration of a generic in Russia requires the provision of documentary evidence of so-called bioequivalence. The necessary evidence is obtained by conducting therapeutic equivalence studies in comparison with the existing patented drug.
 

The need for bioequivalence studies


The therapeutic equivalence of the test drug means that the efficacy and safety of the generic are consistent with the original when used to treat a particular pathology.


Bioequivalent studies imply a process of experimental determination of the compliance of a generic referent. The following parameters are compared:
 

  • Degree of absorption of components in the human body.
  • Absorption rate of drug substance.
  • Time during which the components of the drug reach the maximum concentration in the blood.
  • Maximum amount of the drug in the blood when taking the medicine.
  • Order and scheme of distribution of the treating component to the organs and systems of the body.
  • Way to remove the medicine from the human body and the time that is needed

Full bioequivalence is a correspondence between the features of the reference medicine and the analogue-generic.

 

The process of research on the compatibility of the characteristics of the two medicines with each other makes it possible for a company that wants to register a medicine in Russia, to avoid carrying out costly clinical tests, to shorten the terms of obtaining the required permit and to bring the product to the market.

 

Order of studies 


For testing, a group of healthy people or patients with a specific pathology is needed. The number of subjects varies depending on the specific parameters of the medicine. However, their number can not be less than 12.


As a standard for this type of work, there is a reference preparation that already has a registration in Russia, or its analogue (also registered). The amount of active ingredient in the generic and "original" can differ by no more than 5%


In the process of testing, drugs are used in the same way and in the same amount. The purpose of the study of the first phase is to prove that using both medicines can achieve the same effect

 

Services in organization and conducting studies

 

The Center for Clinical Research "Promedika" offers assistance in organizing and conducting bioequivalence studies that will help to bring the generic to the Russian market in the shortest possible time. Our specialists have the necessary experience and equipment to perform this service. All studies are conducted in strict accordance with Russian and European standards

 

 

The list of works provided within this service includes:

 

 

  • Development of the design of the bioequivalence studies and preparation of the necessary official documents.
  • Preparation of a package of documentation necessary for obtaining the necessary permits in state bodies.
  • Organization of importation of the test generic drug with the passage of all necessary customs procedures.
  • Selection of volunteers who will participate in the study.
  • Conduct research in strict accordance with a pre-compiled protocol.
  • Monitoring of the testing process.
  • Selection of biological samples for verification.
  • Development and testing of research methods.
  • Determination of the amount of active substance of the preparation in selected biological samples.
  • Preparation of reports on the results of the studies.
  • Transfer of all primary data about the work performed and the prepared report to the customer.

 

 

To order a service, use the form on the company's website or call our specialists.

 

For the primary analysis (scheme), cost and timing of registration of funds (LS),
Medical products (MI) and dietary supplements according to the rules of the Russian Federation
and the United Arab Emirates the manufacturer must provide the following data:

Medicine

1. Instructions for use


2. Detailed composition


3. Certificate copyGMP


4. Data on pre-clinical and clinical trials


5. The status of product registration in the country of production



Medical product

1. Description of the medical device


2. Copy of ISO certificate, CE certificate (or other similar documents)


3. Data on pre-clinical and clinical trials


4. The status of product registration in the country of production

 



BAA

1.Instructions for use


2. Full composition with percentage of components


3. A copy of the GMP certificate and / or ISO and / or HACCP


4. Data on pre-clinical and clinical trials


5. A copy of the safety certificate for product

Contact us.

Send us your request