ICH Project ICHQ2(R2) / Q14: Guideline Workshops on the Draft Guideline "ICH Q2(R2): Analytical Method Validation" and "ICH Q14: Analytical Method Development" (draft) reaching Step 2
June 21, 2022
The ICH Q2(R2) / Q14 Expert Working Group (EWG) has been studying the revision and preparation of guidelines on analytical method validation and analytical method development. As a result, the draft ICH Q2(R2)/Q14 guideline reached Step 2 on March 24, 2012, and was published on the official ICH website. The draft guidelines will be available for public comment in Japan in May 2022. In order to promote understanding of the draft guidelines and to support the collection of public comments, ICH Q2 (R2) / Q14 Draft Guideline Workshops were held.