publication . Article . 2018

PRECLINICAL AND CLINICAL ASPECTS OF THE DEVELOPMENT OF BIOMEDICAL CELL PRODUCTS

Open Access Russian
  • Published: 01 Mar 2018 Journal: Ведомости Научного центра экспертизы средств медицинского применения, volume 8, issue 1, pages 23-35 (issn: 1991-2919, eissn: 2619-1172, Copyright policy)
  • Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”
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 dw...
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free text keywords: biomedical cell product, cell line, preclinical studies, clinical trials, specific mechanism of action, efficacy and safety, lcsh:Medicine (General), lcsh:R5-920, Oncology, medicine.medical_specialty, medicine, Experimental research, Oncogenicity, Immunogenicity, Internal medicine, Clinical trial, Preclinical data, Russian federation, business.industry, business
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