Development of In Vitro–In Vivo Correlation for Amorphous Solid Dispersion Immediate-Release Suvorexant Tablets and Application to Clinically Relevant Dissolution Specifications and In-Process Controls

Author:

Kesisoglou Filippos,Hermans Andre,Neu Colleen,Yee Ka Lai,Palcza John,Miller Jessica

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference14 articles.

1. Meeting report: Applied biopharmaceutics and quality by design for dissolution/release specification setting: Product quality for patient benefit;Selen;AAPS J,2010

2. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Guidance for Industry;U.S. Department of Health and Human Services,1997

3. Draft guideline on quality of oral modified release products;European Medicines Agency,2012

4. In vitro and in vivo testing and correlation for oral controlled/modified-release dosage forms;Skelly;Pharm Res,1990

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