Zdrowie i gospodarka · 14/06/2002

International Conference on Harmonisation; Draft Guidance on Q1E Evaluation of Stability Data; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Q1E Evaluation of Stability Data." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This draft guidance is an annex to an ICH guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products." The draft guidance is intended to provide guidance on how to use stability data, generated in accordance with the principles outlined in Q1A(R), to propose a retest period for the drug substance and a shelf life for the drug product.