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Original Articles

Parametric Two-Tier Sequential Quality Assurance Test of Delivery Dose Uniformity of Multiple-Dose Inhaler and Dry Powder Inhaler Drug Products

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Pages 976-984 | Received 27 May 2007, Accepted 23 May 2008, Published online: 10 Sep 2008

REFERENCES

  • Faulkenberry , G. D. , Daley , J. C. ( 1970 ). Sample size for tolerance limits on a normal distribution . Technometrics 12 ( 4 ): 813 – 821 .
  • Huack , W. W. , Shalkh , R. ( 2001 ). Sample size for batch acceptance from single and multitier designs using two-sided normal tolerance interval with specification . J. Biopharm. Stat. 11 : 335 – 346 .
  • Tsong , Y. , Shen , M. , Shah , V. P. ( 2004 ). Three-stage sequential statistical dissolution testing rules . J. Biopharm. Stat. 14 ( 3 ): 1 – 32 .
  • Tsong , Y. , Shen , M. ( 2007 ). Parametric two-tier sequential assurance test of dose content uniformity . J. Biopharm. Stat. 17 : 143 – 157 .
  • U.S. Food and Drug Administration . ( 1998a ). CMC Draft Guidance: Metered Dose Inhaler (MDI) and Dry Power Inhaler (DPI) Drug Products Chemistry, Manufacturing and Controls .
  • U.S. Food and Drug Administration . ( 1998b ). CMC Draft Guidance: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products Chemistry, Manufacturing and Control .

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