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:
- Generic drug studies: acute toxicity, subchronic toxicity, local irritative effect.
- 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.
- Biosimilar studies: acute toxicity, subchronic / chronic toxicity, local irritative effect, specific activity, immunogenicity.
- 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.