FDA guidance for industry extended release solid oral dosage forms: Development, evaluation, and application of in vitro/in vivo correlations

Dissolution Technologies

Volumn 4, Issue 4, 1997, Pages 23-32

  Malinowski, Henry ^a   Marroum, Patrick ^a   Uppoor, Veakata Ramana ^a   Gillespie, Willian ^a   Ahn, Hae Young ^a   Lockwood, Peter ^a   Henderson, James ^a   Baweja, Raman ^a   Hossain, Mohammad ^a   Fleischer, Nichulas ^a   Tillman, Lloyd ^a   Hussain, Ajaz ^a   Shah, Vinod ^a   Dorantes, Angelica ^a   Zhu, Ray ^a   Sun, He ^a   Kumi, Kofi ^a   Machado, Stella ^a   Tammara, Vijaya ^a   Ong Chen, Ting Eng ^a   Mahayni, Houda ^a   Lesko, Lawrence ^a   Williams, Roger ^a   more..

^a US Department of Health and Services Food and DRig Administration   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ANALYTICAL EQUIPMENT; ANALYTICAL PARAMETERS; ARTICLE; BIOEQUIVALENCE; CORRELATION ANALYSIS; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG INDUSTRY; DRUG SCREENING; DRUG SOLUBILITY; EXTENDED RELEASE SOLID ORAL DOSAGE FORM; IN VITRO IN VIVO CORRELATION MODEL; IN VITRO STUDY; IN VIVO STUDY; MATHEMATICAL MODEL; MEDICAL SOCIETY; METHODOLOGY; PRACTICE GUIDELINE; PREDICTION; SUSTAINED DRUG RELEASE; UNITED STATES;

EID: 84962087263     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT040497P23     Document Type: Article

References (8)

1. Gillespie, W. R., Office of Clinical Pharmacology and Biopharmaceutics, FDA, "Convolution-Based Approaches for in Vivo-In Vitro Correlation Modeling."
2. FDA, September 1997, Guidance for Industry; SUPAC-MR: Modified Release Solid Oral Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation.
3. Moore, J. W., and H. H. Flanner, November 1994, "Mathematical Comparison of Curves with an Emphasis on Dissolution Profiles," presented at the AAPS National Meeting, Personal Communication from AAI Inc., Wilmington, NC 28405.
4. Skelly, J. P., et al., 1987, "Report of the Workshop on CR Dosage Forms: Issues and Controversies," Pharmaceutical Research, 4(1):75-78.
5. United States Pharmacopeial Convention, Inc., July 1988, "In Vitro-In Vivo Correlation for Extended Release Oral Dosage Forms," Pharmacopeial Forum Stimuli Article, 4160-4161.
6. Skelly, J. P., et al., September 1990, "Report of Workshop on In Vitro and In Vivo Testing and Correlation for Oral Controlled/Modified-Release Dosage Forms," Journal of Pharmaceutical Sciences, 79(9):849-854.
7. United States Pharmacopeial Convention, Inc., "In Vitro In Vivo Evaluation of Dosage Forms", USP XXIII<1088>, 1927-1929.
8. Skelly, J. P., et al., 1993, Workshop II Report "Scale-up of Oral Extended Release Dosage Forms," Pharmaceutical Research, 10(12):1800-1805.