Technical Guidelines for Human Bioavailability and Bioequivalence Studies of Chemical Pharmaceutical Formulations
Request Technical Guidelines for Human Bioavailability and Bioequivalence Studies of Chemical Pharmaceutical Formulations
  • Local Title:化学药物制剂人体生物利用度和生物等效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
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ZH Official 化学药物制剂人体生物利用度和生物等效性研究技术指导原则 Download
Summary

The Technical Guidelines for Human Bioavailability and Bioequivalence Studies of Chemical Pharmaceutical Formulations was issued on Mar. 18, 2005. It gives technical guidelines for human bioavailability and bioequivalence studies of chemical pharmaceutical formulations in China, which includes:

1. Overview

2. Basic Concepts and Applications of Bioavailability and Bioequivalence

3. Bioavailability and Bioequivalence Study Methods

4. Specific Requirements for Bioavailability and Bioequivalence Studies

5. Special Preparations

6. Conclusion

7. Glossary

8. References