Methods to compare dissolution profiles

Drug Information Journal

Volumn 30, Issue 4, 1996, Pages 1113-1120

  Polli, James E ^a   Rekhi, G Singh ^a   Shah, Vinod P ^b  

^a UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

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

Author keywords

Comparison; Dissolution; Dissolution profile comparison; Metoprolol tartrate

Indexed keywords

METOPROLOL TARTRATE;

BIOEQUIVALENCE; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION; INTERMETHOD COMPARISON; MEDICAL LITERATURE; MODEL; ORAL DRUG ADMINISTRATION; PHARMACEUTICS; PRIORITY JOURNAL; REVIEW; SUSTAINED RELEASE PREPARATION; TABLET; TABLET MANUFACTURE;

EID: 0029828547     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159603000428     Document Type: Review

References (4)

1. Food and Drug Administration. Immediate Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing; In Vivo Bioequivalence Documentation; Guidance. Federal Register. 1995; Part V, Vol. 60, No. 230:61638-61643.
2. Mauger JW, Chilko D, Howard S. On the Analysis of Dissolution Data. Drug Dev Ind Pharm. 1986;12: 969-992.
3. Moore JW, Flanner HH. Mathematical Comparison of Curves with an Emphasis on Dissolution Profiles. Pharm Res. 1994;11:S-171.
4. Rescigno R. Bioequivalence. Pharm Res. 1992;9: 925-928.