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Quality Standards for 14C API for use in human clinical studies
EP20588
Poster Title: Quality Standards for 14C API for use in human clinical studies
Submitted on 20 Dec 2013
Author(s): I Shaw, G Johnston, K Dare, D Dams
Affiliations: Quotient Bioresearch
Poster Views: 893
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Poster Information
Abstract: 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.
Summary: 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.
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