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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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