Statistical assessment of mean differences between two dissolution data sets

Drug Information Journal

Volumn 30, Issue 4, 1996, Pages 1105-1112

  Tsong, Yi ^a,b   Hammerstrom, Thomas ^a   Sathe, Pradeep ^a   Shah, Vinod P ^a  

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

^b Center for Drug Evaluation and Research   (United States)

Author keywords

Confidence region; Dissolution test; Multivariate analysis of variance; Similarity test

Indexed keywords

BIOEQUIVALENCE; COVARIANCE; DRUG APPROVAL; DRUG DOSAGE FORM; DRUG SOLUBILITY; MULTIVARIATE ANALYSIS; PHARMACEUTICS; PRIORITY JOURNAL; REFERENCE VALUE; REVIEW; STATISTICAL ANALYSIS; TABLET; TABLET MANUFACTURE; VARIANCE;

EID: 0029825719     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159603000427     Document Type: Review

References (4)

1. 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. Rockville, MD; Center for Drug Evaluation and Research, FDA; November 1995.
2. Snedecor GW, Cochran WG. Statistical Methods. Seventh Edition. Ames,IO: The Iowa State University Press; 1980.
3. Johnson RA, Wichern DW. Applied Multivariate Analysis. Englewood Cliffs, NJ: Prentice-Hall, Inc.; 1989.
4. Freund JE. Mathematical Statistics. Englewood Cliffs, NJ: Prentice-Hall, Inc., 1962.