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

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

1. Overview

2. The Basic Principle

3. Test Design

4. Data Processing and Analysis

5. Results and Evaluation

6. Frequently Asked Questions and Solutions

7. References

8. Appendix (Analysis Methods for Biological Samples)