Author/Editor		Cvelbar, M
Title		Kakovostni in varnostni vidik uporabe biotehnoloških zdravilnih učinkovin
Translated title		Quality and safety aspect of biotechnology products
Type		članek
Source		Farm Vestn
Vol. and No.		Letnik 46, št. 2
Publication year		1995
Volume		str. 113-8
Language		slo
Abstract		For biotechnology products as for all medicinal products, quality, safety and efficasy need to be established. Biotechnology products can be devided into monoclonal antibodies, recombinant DNA technology products and products obtained by controlled expression of genes. Because of the relatively new procedures and biological materials used to generate these products quality and safety issues require special consideration. Until the hazards and quality issues of these procedures and products are better understood, the approval procedures for biotechnology products will warrant a special procedure.
Descriptors		BIOTECHNOLOGY ANTIBODIES, MONOCLONAL DNA, RECOMBINANT LEGISLATION, DRUG