Understanding bioequivalence testing

Transplantation Proceedings

Volumn 31, Issue 3 SUPPL. 1, 1999, Pages

  Benet, L Z ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CONFERENCE PAPER; COST EFFECTIVENESS ANALYSIS; DRUG BIOAVAILABILITY; DRUG COST; DRUG FORMULATION; DRUG LABELING; DRUG MARKETING; DRUG MONITORING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL;

DRUGS, GENERIC; HUMANS; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0032914001     PISSN: 00411345     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0041-1345(99)00093-7     Document Type: Conference Paper

References (6)

1. Federal Register: 42:1648, 1977.
2. Approved Drug Products with Therapeutic Equivalence Evaluations. 17th Ed. DHHS/Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD, 1997.
3. Sheiner L.B. Stat Med. 11:1992;1777.
4. Benet L.Z., Goyan J.E. Pharmacotherapy. 15:1995;433.
5. Nightingale S.L., Morrison J.C. J Am Med Assoc. 258:1987;1200.
6. U.S. Department of Health and Human Services, Advisory Committee of the Food and Drug Administration. Final report. Washington, DC, 1991.