Pre-clinical study management

Pre-clinical trial of a medical drug is performed with the help of scientific evaluation methods in order to prove safety, quality and efficacy of the medicinal drug (Art. 11 of Federal law №61-FZ dated April, 2010 « On Medicine Circulation»). Pre-clinical trial of the medical drug is performed according to the rules of Good Laboratory Practice approved by the authorized federal government agency.

Preclinical studies — study phase that is performed before clinical trials to ensure elimination of adverse effects of the drug in human use.

Pre-clinical studies are divided into the following blocks:

  1. Generic drug studies: acute toxicity, subchronic toxicity, local irritative effect.
  2. Studies of medicinal drugs that haven’t yet been registered on the Russian market: acute toxicity, chronic toxicity, local irritative effect, specific pharmacological activity, pharmacodynamic studies, pharmacokinetics, resorptive effect studies.
  3. Biosimilar studies: acute toxicity, subchronic / chronic toxicity, local irritative effect, specific activity, immunogenicity.
  4. Planning and writing literature reviews for specific types of toxicity (carcinogenicity, mutagenicity, embryotoxity, teratogenicity, allergenicity, immunotoxicity).

 «SOLYUR Pharmaceuticals Group» company offers full package of services for pre-clinical studies:

  • Pre-clinical study design development
  • Selection of the clinical facility
  • Development of pre-clinical study plan and protocol
  • Test system search and quarantine establishment
  • Monitoring and quality control
  • Statistical processing of data obtained by the end of the pre-clinical study
  • Final report preparation
  • Planning and writing literature reviews for the pre-clinical studies

All documents prepared by our employees fully comply with all current requirements of regulatory agencies.