Development and validation of a Level A in-vitro in-vivo correlation for tofacitinib modified-release tablets using extrudable core system osmotic delivery technology

Author:

Kushner Joseph,Lamba Manisha,Stock Thomas,Wang Ronnie,Nemeth Mary Anne,Alvey Christine,Chen Raymond,DeMatteo Vincent,Blanchard Andrew

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference19 articles.

1. Osmotic drug delivery from asymmetric membrane film-coated dosage forms;am Ende,2000

2. A thermodynamic model for organic and aqueous tablet film coating;am Ende;Pharm. Dev. Technol,2005

3. FDA Center for Drug Evaluation and Research, 2011. Clinical pharmacology and biopharmaceutics review of tofacitinib. NDA203214. Available at:http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203214Orig1s000ClinPharmR.pdf. Accessed 6/14/2016.

4. FDA Center for Drug Evaluation and Research, 2015. Clinical pharmacology and biopharmaceutics review of tofacitinib. NDA208246. Available at:https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208246Orig1s000ClinpharmR.pdf. Accessed 3/21/2017.

5. Guidance For Industry: Extended release Oral Dosage Forms: Development, Evaluation and Application of in Vitro/In Vivo Correlations,1997

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