The role of dissolution testing in the regulation of pharmaceuticals: The FDA perspective

Pharmaceutical Dissolution Testing

Volumn , Issue , 2005, Pages 81-96

  Shah, Vinod P ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

EID: 62949192940     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (16)

1. Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Form. Aug. 1997.
2. Guidance for Industry: Extended Release Solid Oral Dosage Forms: Development, Evaluation and Application of In Vitro/In Vivo Correlations. Sep. 1997.
3. Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. Aug. 2000.
4. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations. Oct. 2000.
5. Amidon GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutics drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995; 12:413-420.
6. Siewert M, Dressman J, Brown CK, Shah VP. FIP/AAPS Guidelines for dissolution in vitro release testing of novel/special dosage forms. AAPS Pharm Sci Tech 2003; 4(1):43-52; Pharm Ind 2003; 65:129-134; Dissolut Technol 2003; 10(1):6-15.
7. Shah VP, Elkins JS, Williams RL. Evaluation of the test system used for in vitro release of drugs from topical dermatological drug products. Pharm Develop Technol 1999; 4:377-385.
8. Shah VP, Tymes NW, Skelly JP. In vitro release profile of clonidinetransdermal therapeutic systems scopolamine patches. Pharm Res 1989; 6:346-351.
9. Gjellan K- Suppositories.
10. Moore JW, Flanner HH. Mathematical comparison of curves with an emphasis on in vitro dissolution profiles. Pharm Tech 1996; 206:64-74.
11. Shah VP, Tsong Y, Sathe P, Liu JP. In vitro dissolution profile comparison-statistics and analysis of the similarity factor, f2. Pharm Res 1998; 15:889-896.
12. Shah VP, Tsong Y, Sathe P, Williams RL. Dissolution profile comparison using similarity factor, f2. Dissolut Technol 1999; 6(3):15.
13. Dressman JB, Amidon GL, Reppas C, Shah VP. Dissolution testing as a prognostic tool for oral drug absorption: immediate release drug dosage forms. Pharm. Res 1998; 15:11-22.
14. Galia E, Nicolaides E, Horter D, Lobenberg R, Reppas C, Dressman JB. Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm. Res 1998; 15:698-705.
15. Lobenberg R, Kraemer J, Shah VP, Amidon GL, Dressman JB. Dissolution testing as a prognostic tool for oral drug absorption:dissolution behavior of glibenclamides. Pharm Res 2000; 17:439-444.
16. Shah VP. Dissolution: quality control test vs. bioequivalence test. Dissolut Technol 2001; 8(4):6-7.