ICH Project ICH Q2(R2) / Q14: Briefing session on the draft guideline "ICH Q2(R2): Validation of Analytical Procedures" and "ICH Q14: Analytical Procedure Development" reached in Step 2

June 21, 2022

The ICH Q2(R2) / Q14 Expert Working Group (EWG) has been working on the revision and development of guidelines for analytical method validation and 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.

 

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