Quality Standards for 14C API for use in human clinical studies
Poster Feb 08, 2011
I Shaw, G Johnston, K Dare, D Dams
The Good Manufacturing Practice (GMP) state that the active pharmaceutical ingredient (API) intended for use in early stage clinical trials should be of "suitable" quality. The Clinic Ready quality standard ensures that the API is synthesised with all the appropriate documentation to facilitate QP release of the final IMP for guman clinical dosing.