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Research Article

Bioequivalence: Stereochemical Considerations

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Pages 1-11 | Published online: 28 Sep 2008

References

  • Bio International 89. TorontoCanada October 1–4, 1989
  • Analytical Method Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies Conference. ArlingtonVA, USA December 3–5, 1990
  • International Harmonization & Consensus Meeting on Bioavailability & Bioequivalence Testing Requirement and Standards. BarcelonaSpain March 18–20, 1991
  • Bio International. FrankfurtGermany May 20–22, 1992
  • From Controversy to Resolution: Bioequivalence of Racemic Drugs. Atlanta, GAUSA October 14–16, 1991
  • Jamali F., Mehvar R., Pasutto F. Enantioselective drug action and disposition: Therapeutic pitfalls. J Phann Sci. 1989; 78: 695–715
  • Caldwell J. The importance of stereochemistry in drug action and disposition. J Clin Pharmacol 1992, In press
  • Ariens E. Stereochemistry, a basis for sophisticated nonsense in pharmacokinetics and clinical pharmacology. Eur J Clin Pharmacol. 1984; 26: 663–668
  • Shah V., Midha K., Dighe S., McGilveray I., Skelly J., Yacobi A., Layloff T., Viswanathan C., Cook C., McDowall R., Pittman K., Spector S. Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies. Pharm Res. 1992; 9: 588–592
  • Good Laboratory Practice Regulations. Department of Health and Human Services, FDA, US Federal Register. 1978, Anonymous
  • Balant L. Is there a need for more precise definitions of bioavailability. Eur J Clin Pharmacol. 1991; 40: 123–126
  • Ariens E. Racemic therapeutics - ethical and regulatory aspects. Eur J Clin Pharmacol. 1991; 41: 89–93
  • Wright M., Jamali F. Methods for the analysis of enantiomers of racemic drugs: Application to pharmacokinetic and pharmacological studies. J Phamol Methods 1992, Submitted to
  • Duddu S., Vakily M., Jamali F., Grant D. Interaction of chiral drugs with chiral excipient: Stereoselective dissolution of propranolol HCl from matrices containing hydroxypropylmethylcellulose. Pharm Res 1992, Submitted to
  • Lee E., Williams K., Day R., Graham G., Champion D. Stereoselective disposition of ibuprofen enantiomers in man. Br J Clin Pharmacol. 1985; 19: 669–674
  • Jamali F., Mehvar R., Russell A., Sattari S., Yakimets W., Koo J. Human pharmacokinetics of ibuprofen enantiomers following different doses and formulations: Intestinal chid inversion. J Pharm Sci. 1992; 81: 221–225
  • Borin M., Cox S., Hageman J., Szpunar G. Serum concentrations of ibuprofen enantiomers following multiple dose administration of sustained release ibuprofen 800 mg tablets. Pharm Res. 1988; 5: 15
  • Walker S., Hardy B. (1991) Alteration in apparent bioequivalency of ibuprofen based on isomer analysis. Presented to the American College of Clinical Pharmacology meeting, Atlanta, GA, October, 14–161991, 7–8
  • Hutt A., Caldwell J. The importance of stereochemistry in the clinical pharmacokinetics of the 2-arylpropionic acid non-steroidal anti-inflammatory drugs. Clin Phamokin. 1984; 9: 371–373
  • Eichelbaum M. Pharmacokinetic and pharmacodynamic consequences of stereoselective drug metabolism in man. Biochem Phannacol. 1988; 37: 93–96
  • Sahajwalla C., Longstreth J., Karim A., Punch E., Cabana B. (1991) Consequences in pooling R-+ S-verapamil in bioequivalence assessment. Presented to the American College of Clinical Pharmacology meeting, Atlanta, GA, October, 14–161991, 14–15
  • Sahajwalla C., Longstreth J., Karim A., El-Shourbagy T., Vetticaden S., Punch E., Malone D., Cabana B. (1991) Bioavailability-bioequivalence of Calan SR, Verapamil SR and Calan IR based on R-, S-, and R,-verapamil. Presented to the American College of Clinical Pharmacology meeting, Atlanta, GA, October, 14–161991, 15–16
  • Singh N., Jamali F., Pasutto F., Coutts R. Stereoselective gas-chromatographic analysis of etodolac enantiomers in human plasma and urine. J Chromatogr. 1986; 312: 331–337
  • Jamali F. Enantioselective aspects of pharmacokinetics: therapeutic implications. Pharmacocinetique: de la recherche a la cliniaue, J. Bres, G. Panis. John Libbey Eurotext. 1992; 11–16
  • Jamali F., Collins D., Berry B., Molder S., Cheung R., McColl K., Cheung H. Comparative bioavailability of two flurbiprofen products: Stereospecific versus conventional approach. Biophann Drug Dispos. 1991; 12: 435–445
  • Jamali F. Stereochemistry and bioequivalence. J Clin Phannacol. 1992, In press
  • Averginos A., Noormohammadi A., Hutt A. Disposition of ibuprofen following administration of a novel controlled release formulation to healthy volunteers. Znt J Phann. 1991; 68: 97–103
  • Donnelly R., Macphee G. Clinical pharmacokinetics and kinetic-dynamic relationships of dilevalol and labetalol. Clin Phannacokin. 1991; 21: 95–109
  • Some views from the Medical Products Agency on the documentation for chid drugs. Registration Division. Medical Product Agency, UppsalaSweden 1991, Anonymous

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