Basic Technical Guidelines for the Research of Chemical Pharmaceutical Formulations
Request Basic Technical Guidelines for the Research of Chemical Pharmaceutical Formulations
  • Local Title:化学药物制剂研究基本技术指导原则
  • 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 化学药物制剂研究基本技术指导原则 Download
Summary

The Basic Technical Guidelines for the Research of Chemical Pharmaceutical Formulations was issued on Mar. 18, 2005. It gives basic technical guidelines for the research of chemical pharmaceutical formulations in China, which includes:

1. Overview

2. Basic Content of Formulation Research

3. Choice of Dosage Form

4. Prescription Research

5. Preparation Process Research

6. Selection of Pharmaceutical Packaging Materials (Containers)

7. Quality Studies and Stability Studies

8. Appendix

9. References