PharmPK Discussion - Health canada BE guideline-Corrected and uncorrected data BE acceptance

• On 17 Jun 2012 at 16:53:54, "Debbie Mischell" (debbie143.at.rediffmail.com) sent the message
  

  
  Hi,
  
  As per the section 2.1 of finalised Health Canada guidelines titled "Comparative
  Bioavailability Standards: Formulations Used for Systemic Effects (Effective
  Date: 2012/05/22)"
  
  Quote from the guideline:
  
  In exceptional cases where a reference batch with a measured drug content
  differing less than 5% from the test product cannot be found, potency correction
  may be accepted. If potency correction is to be used, this intention should be
  pre-specified in the protocol and justified. The results from the potency assay
  of the test and reference products should be submitted. In such cases, the
  applicable bioequivalence standards should be met on both potency-corrected and
  uncorrected data.
  
  When the potency of test and reference products are differing by more than 10 to
  15% (or even more), is it possible to meet the bioequivalence standards on both
  corrected and uncorrected data?
  
  Regards,
  
  Debbie.
  
  

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