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