Zdrowie i gospodarka · 21/08/1995
International Conference on Harmonisation; Draft Guideline on Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products; Availability
The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products.'' This guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guideline is intended to describe the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant deoxyribonucleic acid (r-DNA) derived proteins.