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Research Article

Accelerated Temperature Pharmaceutical Product Stability Determinations

Pages 551-569 | Published online: 20 Oct 2008

REFERENCES

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  • “Guideline for Submitting Documentation for the Stability of Human Drugs and Biologicals” Center for Drugs and Biologies; FDA; Department of Health and Human Services. 55 Pp. 2/87
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  • “A New Linear Model for Stability Prediction” by R. Nash Drug Dev & Ind Pharm 13(3),487–499 (1987)
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  • Outliers in Statistical Data” by V. Barnett and T. Lewis 2nd Edition, John Wiley, New York (1984)
  • “Statistical Evaluation of Nonisothermal Prediction of Drug Stability” by S. Yoshioka, Y. Aso and M. Uchiyama J Pharm Sci 76(10),794–798 (1987)
  • “Nonisothermal Methods for Stability Prediction” by L. S. Rosenberg, D. Pelland, G. Black, D. Aunet, C. Hostetler and D. Wagenknecht J Paren Sci & Tech 40(4),164-168 (1986)
  • “Statistical Analysis of Pharmaceutical Stability Data” by T. Norwood Drug Dev & Ind Pharm 12(4) 553–560 (1986)

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