FDA guidance for industry 1 dissolution testing of immediate release solid oral dosage forms

Dissolution Technologies

Volumn 4, Issue 4, 1997, Pages 15-22

  Shah, Vinod P ^a   Lesko, Lawrence J ^a   Fan, Jim ^a   Fleischer, Nicholas ^a   Handerson, James ^a   Malinowski, Henry ^a   Makary, Moheh ^a   Ouderkirk, Larry ^a   Bay, Suva ^a   Sathe, Pradeep ^a   Singh, Gur Jai Pal ^a   Iillman, Lioyd ^a   Tsong, Yi ^a   Williams, Royer I ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; PANCREATIN; PEPSIN A;

AGITATION; ARTICLE; BIOEQUIVALENCE; BIOPHARMACEUTICS CLASSIFICATION SYSTEM; DISSOLUTION; DRUG BIOAVAILABILITY; DRUG CLASSIFICATION; DRUG DOSAGE FORM; DRUG PENETRATION; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION; IMMEDIATE RELEASE SOLID ORAL DOSAGE FORM; MEAN DISSOLUTION TIME; MOTION; PH; PKA; RESPONSE SURFACE METHOD; ROTATION; VALIDATION PROCESS;

EID: 84962052802     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT040497P15     Document Type: Article

References (11)

1. 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, 12:411-420.
2. 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.
3. 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.
4. Moore, J. W. and H. H. Flanner, 1996, "Mathematical Comparison of Dissolution Profiles," Pharmaceutical Technology, 20 (6):64-74.
5. 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.
6. 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.
7. Shah, V P., J. P. Shelly, W. H. Barr, H. Malinowski, and G. L. Amidon, 1992, "Scale-up of Controlled Release Product-Preliminary Considerations," Pharmaceutical Technology, 16(5):35-40.
8. Shah, V. P., et al., 1995, "In Vivo Dissolution of Sparingly Water Soluble Drug Dosage Forms," International Journal of Pharmaceutics, 125:99-106.
9. Siewert, M., 1995, "FIP Guidelines for Dissolution Testing of Solid Oral Products," Pharm. Ind. 57:362-369.
10. 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.
11. United States Pharmacopeia (USP), S. Pharmacopeial Convention, inc. Rockville, MD.