Technical Guidelines for Clinical Pharmacokinetic Studies of Chemical Pharmaceuticals
Request Technical Guidelines for Clinical Pharmacokinetic Studies of Chemical Pharmaceuticals
  • Local Title:化学药物临床药代动力学研究技术指导原则
  • 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
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ZH Official 化学药物临床药代动力学研究技术指导原则 Download
Summary

The Technical Guidelines for Clinical Pharmacokinetic Studies of Chemical Pharmaceuticals was issued on Mar. 18, 2005. It gives technical guidelines for clinical pharmacokinetic studies of chemical pharmaceuticals in China, which includes:

1. Overview

2. Establishment and Validation of Biological Sample Analysis Methods for Pharmacokinetic Studies

3. Specific Content of Pharmacokinetic Studies

4. Conclusion

5. References