| Author/Editor | Cvelbar, M | |
| Title | Nadzor kakovosti in varnost biotehnoloških farmacevtskih izdelkov | |
| Translated title | Quality control and relevant safety of biotechnological medicinal products | |
| Type | članek | |
| Source | Farm Vestn | |
| Vol. and No. | Letnik 47, št. Suppl | |
| Publication year | 1996 | |
| Volume | str. 173-82 | |
| Language | slo | |
| Abstract | For new biotechnology as for all medicinal products, quality, safety and effeciency need to be established. New biotechnology products can be divided into monoclonal antibodies, recombinant DNA technology products including biotechnology products obtained by transgenic plants and animals 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. Unitil the hazards and quality issues of these procedures and products are better understood, the approval procedures for biotechnology products will warrant a special control procedure. | |
| Descriptors | BIOTECHNOLOGY ANTIBODIES, MONOCLONAL RECOMBINANT PROTEINS QUALITY CONTROL ANIMALS, TRANSGENIC PLANTS, TRANSGENIC |