Skip to main content
Log in

Use of Parent Drug and Metabolite Data in Bioavailability Assessment of a Novel Diltiazem HC1 Once-Daily Product

  • Note
  • Published:
Pharmaceutical Research Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

REFERENCES

  1. J. G. Kelly and K. O'Malley. Clinical Pharmacokinetics of calcium antagonists: An update. Clin. Pharmacokinet. 22:416–433 (1992).

    Google Scholar 

  2. P. Herman, S. D. Rodgers, G. Remones, J. P. Thenot, D. R. London, and P. L. Morselli. Pharmacokinetics of diltiazem after intravenous and oral administration. Eur. J. Clin. Pharmacol. 24:349–352 (1983).

    Google Scholar 

  3. Conduct and Analysis of Bioavailability and Bioequivalence Studies. Part B: Oral modified-release formulations used for systemic effects. Health Protection Branch, Health and Welfare Canada, Ottawa, Canada, 1993.

  4. J. P. Skelly, W. H. Barr, L. Z. Benet, J. T. Doluisio, A. H. Goldberg, G. Levy, D. T. Lowenthal, J. R. Robinson, V. P. Shah, R. J. Temple, and A. Yacobi. Report of the workshop on controlled-release dosage forms: Issues and controversies. Pharm. Res. 4:75–77 (1987).

    Google Scholar 

  5. S. V. Dighe and R. N. Patnaik. Need for metabolite analysis in bioequivalence studies. In K. K. Midha and H. H. Blume (eds), Bio-International. Bioavilability, Bioequivalence and Pharmacokinetics, Medpharm, Stuttgart, 1993, pp. 149–161.

    Google Scholar 

  6. V. P. Shah, K. K. Midha, S. Dighe, I. J. McGilveray, J. P. Skelly, A. Yacobi, T. Layloff, C. T. Viswanathan, C. E. Cook, R. D. McDowall, K. A. Pittman, and S. Spector. Conference Report—Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies. Pharm. Res. 9:588–592 (1992).

    Google Scholar 

  7. C. M. Metzler. Statistical Criteria. In P. G. Welling, F. L. S. Tse, and S. V. Dighe (eds), Pharmaceutical Bioequivalence. Marcel Dekker, Inc., New York, 1991, pp 35–65.

    Google Scholar 

  8. L. Endrenyi, S. Fritsch and W. Yan. Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence. Int. J. Clin. Pharmacol. Ther. Toxicol. 29:394–399 (1991).

    Google Scholar 

  9. H.-U. Schulz and V.W. Steinijans. Striving for standards in bioequivalence assessment: a review. Int. J. Clin. Pharmacol. Ther. Toxicol. 29:293–298 (1991).

    Google Scholar 

  10. P. K. F. Yeung, C. Prescott, C. Haddad, T. J. Montague, C. McGregor, M. A. Quilliam, M. Xei, R. Li, P. Farmer, and G. A. Klassen. Pharmacokinetics and metabolism of diltiazem in healthy males and females following a single oral dose. Eur. J. Drug Metab. Pharmacokinet. 18:199–206 (1993).

    Google Scholar 

Download references

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Eradiri, O., Midha, K.K. Use of Parent Drug and Metabolite Data in Bioavailability Assessment of a Novel Diltiazem HC1 Once-Daily Product. Pharm Res 12, 2071–2074 (1995). https://doi.org/10.1023/A:1016241317260

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1023/A:1016241317260

Navigation