PRECLINICAL AND CLINICAL ASPECTS OF THE DEVELOPMENT OF BIOMEDICAL CELL PRODUCTS

Abstract

The article reviews literature data on development and clinical use of biomedical cell products (BCPs) — a new class of medicines which could be approved for distribution and use only after their specific activity and safety have been thoroughly examined at the stage of experimental research. The article describes main characteristics of BCPs approved in the Russian Federation, as well as specific aspects of their formulation and use. It analyses the main stages of preclinical studies (requirements for animal models, testing of general toxicity, immunogenicity, oncogenicity, tumorigenicity, etc.) that do not cover medicine quality evaluation. The article also dwells upon requirements for the clinical stage of BCPs development. It was shown that the choice of clinically relevant efficacy and safety endpoints could be substantiated by respective preclinical data and accumulated experience of the clinical use of medicines for a particular condition.

Keywords

• biomedical cell product
• cell line
• preclinical studies
• clinical trials
• specific mechanism of action
• efficacy and safety