Transplantation Proceedings
Volume 31, Issue 3, Supplement 1 , Pages 7S-9S , May 1999

Understanding bioequivalence testing

  • L.Z Benet

      Affiliations

    • Department of Biopharmaceutical Sciences, University of California, San Francisco, California, USA
    • Corresponding Author InformationAddress reprint requests to Leslie Z. Benet, PhD, Department of Biopharmaceutical Sciences, University of California, San Francisco, CA 94143-0446

References 

  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 LB. Stat Med. 1992;11:1777
  4. Benet LZ, Goyan JE. Pharmacotherapy. 1995;15:433
  5. Nightingale SL, Morrison JC. J Am Med Assoc. 1987;258:1200
  6. U.S. Department of Health and Human Services, Advisory Committee of the Food and Drug Administration. Final report. Washington, DC, 1991

PII: S0041-1345(99)00104-9

Transplantation Proceedings
Volume 31, Issue 3, Supplement 1 , Pages 7S-9S , May 1999