Choice of laboratory
and coordination of research design

Obtaining of import authorization
for unregistered medicinal product

Logistics of the study drug

control of the research,
preparation of pre-clinical study report

 

Preclinical tests are a mandatory and perhaps the most important stage in the development of a new drug and its introduction into the practice of treating patients in medical institutions and at home. The procedure for preclinical tests of medicines is carried out according to a clear methodology and in accordance with the requirements of the current regulatory documents of the Russian Federation.

 

Need for tests

At the considered stage of the drug development, its effectiveness is evaluated for the treatment of certain pathologies, as well as safety for the human body and the environment. In addition, at this stage, specialists receive data on the following properties of the future medicine:

 

  • pharmacological;
  • Toxic;
  • pharmaceutical;
     

The data collected during the test are included in the package of mandatory documents that are required for registration of the medicine in state regulatory bodies. Results of preclinical tests of the drug are provided together with a protocol and a sample of instructions for the use of the drug. On the basis of the collected data, the state commission decides whether to register or refuse to do so.

 

 

Composition of preclinical tests

The procedure for developing a new pharmaceutical agent, starting with the very idea of producing a pharmaceutical, requires screening tests. They provide an opportunity to understand how effectively various components of the medicine and their combinations affect pathology. Thanks to this, it is possible to select the appropriate components of the new medicine in terms of efficiency and economy.

Once the component composition of the drug is selected, research is conducted on its safety and effectiveness. The safety audit process aims to identify the negative effects of the future drug on the human body and the environment.

 

 

n the safety audit process, two stages of work are carried out:

 

  • Toxicity of general order. Specialists assess acute and chronic toxicity. The amount of medicine that will negatively affect the functioning of the internal organs of the human body is revealed. It is established whether a pharmacological agent can damage the work of the body.
  • Specific toxicity of the drug. This preclinical study reveals the effect of the drug on the reproductive capacity of a person and the development of an embryo in the body. In addition, employees who conduct tests, check for possible allergic reactions, effects on the immune system, carcinogenic and mutagenic properties.

 

After the safety check, the effectiveness of the test medication is evaluated, that is, its ability to save a person from pathology. These tests are carried out on experimental animals. On the basis of the data obtained, instructions for use and a plan for subsequent research are developed.  

 

 

The next step is to determine the amount of medicine needed for treatment, and the formation of schemes for its intake by a person. These problems are solved in the process of pharmacokinetic preclinical studies. It is determined:

 

  • how the medicine is absorbed into the body;
  • how the drug is distributed to the organs and systems of the body;
  • how the drug affects human metabolism;
  • how the remnants of the medicine are removed from the organs.

The data obtained in the process of the tests described above serve to evaluate the bioequivalence of the generic medicine.

 

How to organize tests

The "Promedika" Center will help you to organize and conduct preclinical tests of medicines. Our company has the necessary tools and owns the methods that allow to assess the toxicity, pharmacological properties and other characteristics of the pharmaceutical drug.

The reliability of the information obtained and the reproducibility of the tests are guaranteed by the observance of GLP and GCP.

The list of services provided by the Center "Promedika" includes:

  • Selection of the necessary base for future testing.
  • Selection of the necessary base for future testing.
  • Preparation of a protocol for future testing.
  • Monitoring and quality control of ongoing research.
  • Processing of statistical data obtained during the tests.
  • Preparation of the necessary reporting documentation.

The company conducts tests in the shortest possible time with the preparation of a detailed calculation of the cost of each stage. We have sufficient experience in providing such services, which guarantees the quality of the documents produced and the absence of inconsistencies in the reports.

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