• Q1A - Q1F Stability

    Code Document Title Previously coded
    • Finalised Guideline:
      February 2002

      Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in February 2002. This document describes general principles for reduced stability testing and provides examples of bracketing and matrixing designs.

      Implementation :

      Step 5

      EU :

      Adopted by CPMP, February 2002, issued as CPMP/ICH/4104/00

      MHLW :

      Adopted 31 July 2002 as PFSB/ELD Notification No. 0731004

      FDA :

      Published in the Federal Register, Vol. 68, No. 11, p. 2339-2340, 16 January 2003