PharmPK Discussion - Calculate Sample size for Pivotal study-Canadian Submission

• On 17 Nov 2011 at 17:38:17, narasimha reddy (r.nara.simha.reddy123.-at-.gmail.com) sent the message
  

  
  Dear all,
  
  How to calculate number of subjects for pivotal study for canada BE
  study.
  
  Is it similar to US FDA calculation?
  
  Narasimha Reddy
  
  

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• On 17 Nov 2011 at 21:54:03, "DR.GUNA SAKARAN" (drgunasakaran.-at-.gmail.com) sent the message
  

  
  Dear Mr.Narasimha Reddy,
  
  The formula for calculating sample sizes for Canadian BE study is based
  on Hauschke et al., Sample size determination for bioequivalence
  assessment using a multiplicative model. Journal of Pharmacokinetics and
  Biopharmaceutics, 1992; 20(5): 557-561.
  
  To use the table:
   a) Obtain an estimate of the intrasubject CV from the literature.
   b) Choose table A1-A or A1-B depending on the bioequivalence interval
  required.
   c) Choose the power required (80% or 90%).
   d) Choose an expected true ratio of test over reference means (usually
  100%, but consider potency differences between the test and reference
  products).
   e) Go down the column until you arrive at the rounded CV. The number is
  the sample size.
  
  This sample size algorithm should be provided in the study protocol and
  anticipated CV
  declared.
  
  Regards,
  Dr.S.Gunasakaran, MD
  Head - Clinical Research & Medical Affiars
  
  

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