Zdrowie i gospodarka · 25/09/2001

International Conference on Harmonisation; Draft Guidance on ICH Q1D Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Q1D Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 This draft guidance is an annex to an ICH draft guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products," that published in the Federal Register of April 21, 2000 (65 FR 21446). ICH Q1D is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in ICH Q1A(R).