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    Home > Food News > Nutrition News > CDE publishes ICH "Q2(R2): Analytical Method Validation" and "Q14: Analytical Method Development" guidelines for comments

    CDE publishes ICH "Q2(R2): Analytical Method Validation" and "Q14: Analytical Method Development" guidelines for comments

    • Last Update: 2022-10-01
    • Source: Internet
    • Author: User
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    Source: CDE website



    The ICH Guiding Principles for Q2(R2): Validation of Analytical Methods and Q14: Development of Analytical Methods are now in Phase 3 Regional Public Comment Phase
    .




    The original English and Chinese translations of the draft guidelines Q2(R2) and Q14 are contained in annexes 1-4
    .




    If there are any relevant suggestions from all walks of life, please feedback
    through the contact email address before July 15, 2022.




    Contact: Tian Jie, Zeng Fanxu



    Email: tianj@cde.




    Appendix 1: Q2 (R2): Verification of analytical methods (draft)



    Appendix 2: [Chinese] Q2 (R2): Verification of analytical methods (draft)



    Appendix 3: Q14: Development of analytical methods (draft)



    Appendix 4: [Chinese] Q14: Development of analytical methods (draft)



    Appendix 5: [Template] Feedback on the English draft



    Appendix 6: [Template] Chinese the feedback of the translation



    Drug Evaluation Center of the State Drug Administration



    April 25, 2022



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