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Research Article

COULD PUBLICATION OF BIOINEQUIVALENCE DATA DISCOURAGE FRAUDS ON BIOEQUIVALENCE TRIALS?

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Pages 63-66 | Published online: 06 Oct 2002

REFERENCES

  • Note for Guidance on the Investigation of Bioavailability and Bioequivalence. CPMP/EWP/QWP/1401, December 2000
  • In Vivo Bioequivalence Guidances. General Information. United States Pharmacopoeia XXIII 1998, Suppl. 8: 4382–4426, Food and Drug Administration (FDA)
  • Marzo A. Open Questions on Bioequivalence: Some Problems and Some Solutions. Pharmacol. Res. 1999; 40: 357–368
  • Smith R.J. Scientific Fraud Probed at AAAS Meeting. Science 1985; 228: 1292–1293
  • Weidekamm E., Rüsing G., Caplain H., Sörgel F., Crevoisier C. Lack of Bioequivalence of a Generic Mefloquine Tablet With the Standard Product. Eur. J. Clin. Pharmacol. 1998; 54: 615–619
  • Lam YWF., Ereshefsky L., Toney G., Dugan D., Gonzales C. Bioavailability Comparison of Brand and Generic Clozapine Formulations. Br J Clin Pharmacol. 1051: 269
  • Joshi MV., Gokhale PC., Pohujani SM., Dalvi SS., Karandikar SM., Kshirsagar NA. Bioinequivalence of Marketed Diltiazem Preparations. Eur. J. Clin. Pharmacol. 1990; 39: 189–190
  • Beermann B., Groschinsky-Grind M., Lindstrôm B. Bioavailability of Two Hydrochlorothiazide Preparations. Eur. J. Clin. Pharmacol. 1977; 11: 203–205
  • Locniskar A., Greenblatt DJ., Harmatz JS., Shader RI. Bioinequivalence of a Generic Brand of Diazepam. Biopharm. Drug Dispos. 1989; 10: 597–605
  • Meyer MC., Straughn AB., Jarvi EJ., Wood GC., Pelsor FR., Shah VP. The Bioinequivalence of Carbamazepine Tablets with a History of Clinical Failure. Pharm. Res. 1992; 9: 1612–1616
  • Adams WP., Hasegawa J., Johnson RN., Haring RC. Conjugated Estrogens Bioinequivalence: Comparison of Four Products in Postmenopausal Women. J. Pharm. Sci. 1979; 68: 986–991
  • Lindenbaum J., Mellow MH., Blackstone MO., Butler VP. Variation in Biological Availability of Digoxin From Four Preparations. N. Engl. J. Med. 1971; 24: 1344–1347
  • Rennie D. Editorial: Thyroid Storm. J. Am. Med. Assoc. 1997; 277: 1238–1243
  • Spigelman MK. Bioequivalence of Levothyroxine Preparations for Treatment of Hypothyroidism. J. Am. Med. Assoc. 1997; 277: 1199–1200
  • Dong BJ., Hauck WW., Gambertoglio JG., Gee L., White JR., Bubp JL., Greenspan FS. Bioequivalence of Generic and Brand-name Levothyroxine Products in the Treatment of Hypothyroidism. J. Am. Med. Assoc. 1997; 277: 1205–1213
  • Eckert CH. Bioequivalence of Levothyroxine Preparations: Industry Sponsorship and Academic Freedom. J. Am. Med. Assoc. 1997; 277: 1200–1201
  • Gleiter CH., Gundert-Remy U. Bioinequivalence and Drug Toxicity. How Great is the Problem and What Can Be Done?. Drug Saf. 1994; 11: 1–6

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