Overview
On November 8, 2022, the CDE issued a notice on “Questions and Answers for Dissolution Profile Studies ⟨Technical Guidelines for Pharmaceutical Change Studies of Marketed Chemical Drugs (Trial) ⟩”
Introduction:
The domestic guidelines for individual drugs specify dissolution profile studies, that should be performed with reference, and the unspecified parts of individual drug guidelines can be performed with reference to this.
This Q&A Mainly answers the following questions:
How to select:
- samples,
- Dissolution medium,
- Apparatus,
- Rotation speed,
- Sampling points of dissolution profiles
How to conduct comparative studies of :
- dissolution profiles of different strengths
- dissolution profiles of sustained and controlled-release preparations
- dissolution profiles of enteric-coated preparations.
Learn More:
Brochure: Committed to your Success in China
We are a global consulting firm that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, biotech and life-consumer companies worldwide.
GRP can act as your local Agent in China, Contact our team today to Inquire!
- Contact Us – Global Regulatory Partners, Inc.
- Email: info@globalregulatorypartners.com
- Telephone : (+1) 781-672-4200
References
Learn more about NMPA. For the link, click here (Only available in Chinese).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.