89
Views
2
CrossRef citations to date
0
Altmetric
Research Article

Dependence of In Vitro-In Vivo Correlation Analysis Acceptability on Model Selections

Pages 89-96 | Received 05 Jan 1998, Accepted 30 Jun 1998, Published online: 06 Oct 2008

REFERENCES

  • M. Uchiyama, Prospect of drug product quality—regulatory considerations, Proc. Int. Symp. Controlled Release Bioact. Mater., 23, 63–63(1996).
  • Extended Release Solid Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations, Center for Drug Evaluation and Research, Food and Drug Administration, September, 1997.
  • J. G. Wagner, Do you need a pharmacokinetic model, and, if so. which one?, J. Pharmacokin. Biopharm., 3, 457–478(1975).
  • G. S. Rekhi, N. E. Eddington, M. J. Fossler, P. Schwartz, L. J. Lesko, and L. L. Augsburger, Evaluation of in vitro release rate and in vivo absorption characteristics of four metoprolol tartrate immediate-release tablet formulations, Pharm. Dev. Technol., 2, 11–24(1997).
  • J. E. Polli, G. S. Rekhi, L. L. Augsburger, and V. P. Shah, Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets, J. Pharm. Sci. 86, 690–700(1997).
  • United Stares Pharmacopeia, NF 18, , 23rd ed., United States Pharmacopeial Convention, Inc., Rockville, MD, 1994.
  • H. Akaike, An Information Criterion (AIC), Math. Sci., 14, 5–9(1976).
  • J. E. Polli, J. R. Crison, and G. L. Amidon, Novel approach to the analysis of in vitro-in vivo relationships, J. Pharm. Sci., 85, 753–760(1996).
  • J. E. Polli, Analysis of in vitro-in vivo data, in Scientific Foundations for Regulating Drug Product Quality ( G. L. Amidon, J. R. Robinson, and R. L. Williams, eds.), AAPS Press, Alexandria, VA, pp. 335–351(1997).
  • J. E. Polli and M. J. Ginski, Human drug absorption kinetics and comparison to Caco-2 monolayer permeabilities, Pharm. Res., 15, 47–52(1998).
  • R. E. Madsen, U.S. v. Barr Laboratories: a technical perspective, PDA J. Pharm. Sci. Technol., 48, 176–179(1994).
  • D. B. Barr and G. R. Dolecek, Out-of-specification laboratory results in the production of pharmaceuticals, Pharm. Technol., 20, 54–60(1996).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.