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Research Article

A discussion on room temperature for stability testing

Pages 849-859 | Published online: 20 Oct 2008

References

  • Patel R. M. Stability and the FDA Guidelines – Proposed Guideline for Stability Studies for Human Drugs and Biologicals. 13th Annual Industrial Pharmacy Management Conference, Madison, Wisconsin. October, 1980
  • Haynes J. D. J. Pharm. Sci. 1971; 60: 927
  • Scher M. J. Pharm. Sci. 1980; 69: 325
  • 1978, Report of the PMA Quality Control Section Committee on Stability and Expiration Dating, Second edition, March 13
  • 1980, Report of the PMA Quality Control Section Committee on Stability and Expiration Dating, March
  • Wu-Huang Yang. Theoretical Analysis of the Effect of the Temperature Fluctuation in an Isothermal stability study, Drug Development and Industrial Pharmacy, Submitted

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