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Original Articles

Uniform matrix stability study designs

Pages 477-494 | Published online: 29 Mar 2007

References

  • Nordbrock , E. 1992 . Statistical comparison of stability study designs . J Biopharm Statist , 2 ( 1 ) : 91 – 113 .
  • Food and Drug Administration . 1987 . Guideline for Submitting Documentation of the Stability of Human Drugs and Biologies , Rockville, MD : Center for Drugs and Biologies Office of Drug Research and Review .
  • International Conference on Harmonization . 1993 . Harmonized Tripartite Guideline Stability Testing of New Drug Substances . Step 4 Draft Endorsement . 1993 .
  • Ruberg , SJ and Stegeman , J. 1991 . Pooling data for stability studies:Testing the equality of batch degradation slopes . Biometrics , 47 ( 3 ) : 1059 – 1069 .
  • Murphy , JR and Weisman , D. . Biopharmaceutical Proceedings . pp. 196 – 200 . Alexandria, VA : American Statistical Association .

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