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Pre-clinical trials

Доклинические исследования

Pre-clinical trials are the base of safety and security of medicine quality. Pre-clinical trials are the first and at the same time very important stage in the process of a new pharmaceutical product launch.

The quality and the volume of performed investigations directly influence the further medicine registration process, and also provide the safety of people involved in the following clinical trials.

The company «Solyurpharm» provide a full range of pre-clinical trials, both for original and reproducible medicines and pharmaceutical substances:

  • The choice of research center
  • The elaboration of experiment design
  • The determination of optimal volume of investigation
  • The organization of experimental part of investigation
  • Reporting the data on the pre-clinical trials in accordance with the Regulatory Authorities of the Russian Federation
  • Providing the assistance until the approval of the reporting data by the Regulatory Bodies

Our pre-clinical trial services include:

  1. For generic drugs:
    • Toxicology assessment (the study of common toxicological action )
    • Pharmacokinetic investigation (the study of peculiarities of absorption, distribution, metabolism and excretion of a drug).
  2. Additionally for original drugs:
    • The study of cumulative action
    • The study of local irritation effect
    • The evaluation of specific toxicity
    • The determination of specific pharmacological activation
    • The study of comparable antimicrobial activation of antibiotics