REFERENCES
Amidon, G. L., H. Lennernas, V. P. Shah, and J. R. Crison, 1995, "A Theoretical Basis For
a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product
Dissolution and In Vivo Bioavailability," Pharmaceutical Research, 12:413-420.
FDA, 1995, Center for Drug Evaluation and Research, Guidance for Industry: Immediate
Release Solid Oral Dosage Forms. Scale-up and Post-Approval Changes: Chemistry,
Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence
Documentation [SUPAC-IR], November 1995.
Meyer, M. C., A. B. Straughn, E. J. Jarvi, G. C. Wood, F. R. Pelsor, and V. P. Shah, 1992,
"The Bioequivalence of Carbamazepine Tablets with a History of Clinical Failures,"
Pharmaceutical Research, 9:1612-1616.
Moore, J. W. and H. H. Flanner, 1996, "Mathematical Comparison of Dissolution Profiles,"
Pharmaceutical Technology, 20 (6):64-74.
Shah, V. P., et al., 1989, "In Vitro Dissolution Profile of Water Insoluble Drug Dosage Forms in
the Presence of Surfactants," Pharmaceutical Research, 6:612-618.
Shah, V. P., et al., 1992, "Influence of Higher Rate of Agitation on Release Patterns of Immediate
Release Drug Products," Journal of Pharmaceutical Science, 81:500-503.
Shah, V. P., J. P. Skelly, W. H. Barr, H. Malinowski, and G. L. Amidon, 1992, "Scale-up
of Controlled Release Products - Preliminary Considerations," Pharmaceutical
Technology, 16(5):35-40.
Shah, V. P., et al., 1995, "In Vivo Dissolution of Sparingly Water Soluble Drug Dosage Forms,"
International Journal of Pharmaceutics, 125:99-106.
Siewert, M., 1995, "FIP Guidelines for Dissolution Testing of Solid Oral Products," Pharm.
Ind. 57:362-369.
Skelly, J. P., G. L. Amidon, W. H. Barr, L. Z. Benet, J. E. Carter, J. R. Robinson, V. P. Shah, and
A. Yacobi, 1990, "In Vitro and In Vivo Testing and Correlation for Oral Controlled/Modified-
Release Dosage Forms," Pharmaceutical Research, 7:975-982.
United States Pharmacopeia (USP), U.S. Pharmacopeial Convention, Inc. Rockville, MD.