Avtor/Urednik		Cvelbar, M
Naslov		Kakovostni in varnostni vidik uporabe biotehnoloških zdravilnih učinkovin
Prevedeni naslov		Quality and safety aspect of biotechnology products
Tip		članek
Vir		Farm Vestn
Vol. in št.		Letnik 46, št. 2
Leto izdaje		1995
Obseg		str. 113-8
Jezik		slo
Abstrakt		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.
Deskriptorji		BIOTECHNOLOGY ANTIBODIES, MONOCLONAL DNA, RECOMBINANT LEGISLATION, DRUG