Preclinical studies

Preclinical studies are an integral stage in the development and introduction of new drugs into clinical practice. The main tasks in the process of preclinical studies are the study of the pharmacodynamics and pharmacokinetics of the study drug, its toxic and pharmaceutical properties, the minimum toxic dose is determined, and the efficacy and safety are evaluated.

AX CT provides services for the organization of preclinical studies of medicines (pharmaceutical substances and drugs) in accordance with the requirements of international GLP rules.

Preclinical drug safety studies are aimed at identifying a possible damaging effect of drugs and assessing the safety of its use. Such studies are conditionally divided into two large blocks: a study of general toxicity and a study of specific toxicity. Preclinical efficacy studies – assessment of the pharmacological activity of a potential drug for the treatment of a particular disease, as well as the pharmacodynamic properties of drugs. This type of research is carried out on models of laboratory animal diseases and is the basis for the development of indications for use and the design of further clinical studies.

Preclinical studies are a necessary step in the registration of:

• original drug
• new fixed combination
• generic, registered in the country of origin
• a new original dosage form, a new route of administration, a new indication
• the presence in the dosage form of excipients that do not have permission for medical use in the Russian Federation.