Dissolution: A quality control test vs. A bioequivalence test

Dissolution Technologies

Volumn 8, Issue 4, 2001, Pages

  Shah, Vinod P ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG;

BIOAVAILABILITY; BIOEQUIVALENCE; DISSOLUTION; DRUG DOSAGE FORM; DRUG FORMULATION; FOOD AND DRUG ADMINISTRATION; IN VITRO STUDY; INTESTINE MUCOSA PERMEABILITY; MATHEMATICAL PHENOMENA; MEASUREMENT ACCURACY; NOTE; PH; QUALITY CONTROL; RELIABILITY; REPRODUCIBILITY; SOLUBILITY;

EID: 12244278403     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT080401P6     Document Type: Note

References (7)

1. Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Form, August 1997.
2. Guidance for Industry: Extended Release Solid Oral Dosage Forms: Development, Evaluation and Application of In Vitro/In Vivo Correlations, September 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, August 2000.
4. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations, October 2000.
5. G. L. Amidon, H. Lennernas, V. P. Shah and J. R. Crison. A theoretical basis for a biopharmaceutics drug classification: The correlation of in vitro drug product dissolution and in vivo bioavail ability. Pharm. Research. 12: 413-420 (1995)
6. V. P. Shah, Y. Tsong, P. Sathe and J. P. Liu. In vitro dissolution profile comparison - statistics and analysis of the similarity factor, f2. Pharm. Research.15:889-896,1998.
7. V. P. Shah, Y. Tsong, P. Satheand R. L Williams. Dissolution profile comparison using similarity factor, f2. Dissolution Technologies. 6(3),15,1999.