Regulatory Experience with Continuous Manufacturing and Real Time Release Testing for Dissolution in New Drug Applications

Author:

Kakhi Maziar,Li Jing,Dorantes Angelica

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference42 articles.

1. Pharmaceutical CGMPS for the 21st Century — A Risk-Based Approach,2004

2. FDA Statement on FDA's Modern Approach to Advanced Pharmaceutical Manufacturing. United States Food and Drug Administration, 2019.

3. Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization,2017

4. Advanced Manufacturing | FDA (content current as of 2023-05-22).

5. Achieving continuous manufacturing for final dosage formation: challenges and how to meet them May 20–21 2014 continuous manufacturing symposium;Byrn;J Pharm Sci,2015

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