Technical Guidelines for Stability Research of Chemical Drugs
Request Technical Guidelines for Stability Research of Chemical Drugs
  • Local Title:化学药物稳定性研究技术指导原则
  • Country/Region:Chinese Mainland
  • Competent Authority: Former China Food and Drug Administration (CFDA)
  • Type:Guideline
  • Status:In force
  • Release Date:2005-03-18
  • Implementation Date:2005-03-18
Document
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ZH Official 化学药物稳定性研究技术指导原则 Download
Summary

The Technical Guidelines for Stability Research of Chemical Drugs was issued on Mar. 18, 2005. It gives technical guidelines for stability research of chemical drugs in China, which includes:

I. Overview

2. Key Points of Stability Research Design

3. Test Methods for Stability Research 

4. Results of Stability Research 

5. Explanation of Terms

6. References

7. Appendix