[Demonstration of quality, safety and efficacy of biological products subject to changes in their manufacturing process].

Ensuring quality, safety and efficacy of the medicinal products placed on the market of the Russian Federation constitutes the area that requires strict regulation. When changes are made to the manufacturing process, the manufacturer generally needs to evaluate the relevant quality attributes of the product to demonstrate that modifications did not occur that would adversely impact the safety and efficacy of the drug. Where there is the lack of a sound legal basis, there is a need in harmonization of current Russian legislation with international and European rules governing medicinal product for human use to ensure quality, safety and efficacy thereof.

[Chromosome variability in the tissue culture of rare Gentiana species].

Cytogenetic analysis of plants and tissue culture of Gentiana lutea, G. punctata, G. acaulis has been carried out.

[Mixoploidy in wild and cultivated Cruciferae species able to hybridize with Brassica napus].

Chromosome numbers in root meristem cells of the seedlings of wild and cultivated Cruciferae species able to hybridize with Brassica napus have been studied. The seedlings of Brassica junceae, Diplotaxis tenuifolia and Raphanum raphanistrum showed exclusively diploid metaphases. Up to 5% of B.

[Cytogenetic variation of Ungernia victoris cell lines during cultivation on culture media of different composition].

Chromosome numbers of U. victoris cell lines obtained from the same bulb and cultured for a long time on different agar-solidified and liquid nutrient media differed significantly. The components of the nutrient media including phytohormones did not influence the ratio of cells with different ploidy levels in various lines while transfer of the calluses to the liquid media resulted in the increase of diploid metaphase frequencies.