Pharmaceutical Research

, Volume 8, Issue 9, pp 1210–1213 | Cite as

Determination of Release Limits: A General Methodology

  • Paul V. Allen
  • Gary R. Dukes
  • Mark E. Gerger
Note
release limits average slope expiration dating batch release covariance analysis Satterthwaite approximation 

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REFERENCES

  1. 1.
    Guidelines for submitting documentation for the stability of human drugs and biologics, Center for Drugs and Biologics, Food and Drug Administration, U.S. Department of Health and Human Services, Washington, DC, February 1987.Google Scholar
  2. 2.
    J. R. Taylor. An Introduction to Error Analysis, University Science Books, Mill Valley, CA, 1982, pp. 40–80.Google Scholar
  3. 3.
    G. W. Snedecor and W. G. Cochran. Statistical Methods, 7th ed., Iowa State Press, Ames, 1980, pp. 97–98.Google Scholar
  4. 4.
    J. T. Carstensen. In J. Swarbick (ed.), Drug Stability, Principles and Practices (Vol. 43 of Drugs and the Pharmaceutical Sciences), Marcel Dekker, New York, 1990, pp. 214–215.Google Scholar

Copyright information

© Plenum Publishing Corporation 1991

Authors and Affiliations

  • Paul V. Allen
    • 1
  • Gary R. Dukes
    • 1
  • Mark E. Gerger
    • 1
  1. 1.Pharmaceutical Control DivisionThe Upjohn CompanyKalamazoo

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