Method considerations for Caco-2 permeability assessment in the biopharmaceutics classification system

Pharmacopeial Forum

Volumn 28, Issue 1, 2002, Pages 164-168

  Tolle Sander, Sanna ^a   Polli, James E ^a  

^a UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 12444346800     PISSN: 03634655     EISSN: 15421945     Source Type: Journal    
DOI: None     Document Type: Article

References (6)

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2. CDER, Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients Based on a Biopharmaceutics Classification System. Food and Drug Administration: Rockville, MD, 2000.
3. (1089) In Vitro Absorption-Indicating Cell Culture System. Pharmacopeial Previews, PF 25(5), 1999, 8733-8737.
4. Soergel K.H. Showdown at the tight junction. Gastroenterology. 1993, 105(4): 1247-50.
5. Lentz K.A.; Hayashi J.; Lucisano L.J.; Polli J.E. Development of a more rapid, reduced serum culture system for Caco-2 monolayers and application to the biopharmaceutics classification system. Int. J. of Pharm. 2000, 200(1), 41-51.
6. Adson A.; Raub T.J.; Burton P.S.; Barsuhn C.L.; Hilgers A.R.; Audus K.L.; Ho N.F. Quantitative approaches to delineate paracellular diffusion in cultured epithelial cell monolayers. J. Pharm. Sci. 1994, 83(11), 1529-36.