NONCLINICAL STUDIES OF BIOTECHNOLOGY DERIVED MEDICINAL PRODUCTS - THEORY AND PRACTICE SPECIFICITY
Nonclinical studies of biotechnology-derived medicinal products are discussed in the article in terms of new original fusion protein RPH-104 - high potency IL-1β signal pathway antagonist. Specificity of biotherapeutics is connected to complexity of molecules. Efficacy, pharmacokinetic and toxicity nonclinical studies of the biotherapeutics are conducted using relevant species taking into consideration potent immunogenicity. Cytotoxic reactions risk assessment is also important. Accurate nonclinical studies planning can help to obtain sufficient information about potential target organs for toxicity, reversibility of toxic effects and determine safety parameters. According to ethical principles in vivo studies can be optimized using modern in silico analysis, computer modelling and in vitro testing.