Biopharmaceutical implications of excipient variability on drug dissolution from immediate release products

Author:

Zarmpi P.,Flanagan T.,Meehan E.,Mann J.,Østergaard J.,Fotaki N.

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference74 articles.

1. Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control;Yu;Pharm. Res.,2008

2. Understanding pharmaceutical quality by design;Yu;AAPS J.,2014

3. FDA, Quality Considerations for Continuous Manufacturing: Guidance for Industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM632033.pdf. (accessed 30 March 2019).

4. Clinical relevance of dissolution testing in quality by design;Dickinson;AAPS J.,2008

5. Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization;Grady;J. Pharm. Sci.,2018

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