FY2016 Regulatory Science Report: Locally-Acting Gastrointestinal Drugs
This section contains only new information from FY2016. For background scientific information and outcomes from previous years on this research topic, please refer to the FY15 Regulatory Science Research Report on Locally-Acting Gastrointestinal Drugs.
ORS staff facilitating research in this area
- Xinyuan Zhang, Hong Wen, Dajun Sun, Jianghong Fan, and other ORS staff members
Projects and Collaborators
- Correlation of mesalamine pharmacokinetics with local availability
- Site PI: Duxin Sun, Ph. D.
- Contract #: HHSF223201300460A
Publications and Presentations
- Yu A, Baker JR, Fioritto AF, Wang Y, Luo R, Li S, Wen B, Bly M, Tsume Y, Koenigsknecht MJ, Zhang X, Lionberger R, Amidon GL, Hasler WL, Sun D.
Measurement of in vivo Gastrointestinal Release and Dissolution of Three Locally Acting Mesalamine Formulations in Regions of the Human Gastrointestinal Tract. Mol Pharm. 2017 Feb 6;14(2):345-358
- Draft product-specific guidance on Fidaxomicin oral tablet (Aug 2015)
- Draft product-specific guidance on Ferric citrate tablet (Sep 2015)
- Revision of Draft product-specific guidance on Sevelamer carbonate tablet (Sep 2015)
- Revision of Draft product-specific guidance on Colesevelam hydrochloride tablet (Sep 2015) and Draft product-specific guidance on Colesevelam hydrochloride powder for suspension (Jan 2016)
- Revision of Draft product-specific guidance on Mesalamine delayed release capsule (Jun 2016)
- Revision of Draft product-specific guidances on Mesalamine delayed release tablet: NDA 19651 (Oct 2016), NDA 21830 (Jun 2016), and NDA 22000 (Jun 2016)