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Research Article

A Novel Bending Point Criterion for Dissolution Profile Interpretation

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Pages 885-892 | Published online: 30 Jun 2001

REFERENCES

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  • Food and Drug Administration. FDA Guidance for Industry: Immediate Release Solid Dosage Forms: Scale-up and Post-Approval Changes (SUPAC-IR): Chemistry, Manufacturing and Controls. In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation; FDA November 1995
  • Food and Drug Administration. FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms; FDA August 1997
  • Food and Drug Administration. FDA Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation and Application of In Vitro/In Vivo Correlations; FDA September 1997
  • Food and Drug Administration. FDA Guidance for Industry: Modified Release Oral Dosage Forms: Scale-up and Post-Approval Changes (SUPAC-MR): Chemistry, Manufacturing and Controls. In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation; FDA September 1997
  • Sathe P. M., Tsong Y., Shah V. P. In-Vitro Dissolution Profile Comparison: Statistics and Analysis, Model Dependent Approach. Pharm. Res. 1996; 13(12)1799–1803
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  • De Maesschalck R. Chemometric Characterisation of Pharmaceutical Substances and Products. Ph.D. thesis, Free University of Brussels, Belgium 2000
  • Lindsey J. K. Parametric Statistical Inference. Clarendon Press, OxfordUK 1996

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