Zdrowie i gospodarka · 10/07/1996

International Conference on Harmonisation; Final Guideline on Stability Testing of Biotechnological/Biological Products; Availability

The Food and Drug Administration (FDA) is publishing a final guideline entitled ``Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products.'' The guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline is intended to provide guidance to applicants regarding the type of stability studies that should be provided in support of marketing applications for biotechnological/biological products.