PharmPK Discussion - EU 90% CI acceptance criteria for Tacrolimus

• On 13 Jun 2012 at 19:54:01, narasimha reddy (r.nara.simha.reddy123.-at-.gmail.com) sent the message
  

  
  Hi,
  
  We are planning to conduct bioequivalence study of Tacrolimus for EU market. Since, it is
  a Narrow therapeutic index drug, whether we need to change the 90% CI acceptance criteria
  for Cmax from 80% - 125% to 90% - 111%?
  

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• On 14 Jun 2012 at 07:30:52, David Bourne (bourne5321.-a-.gmail.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  PharmPK wrote:
  We are planning to conduct bioequivalence study of Tacrolimus for EU
  market. [...] whether we need to change the 90% CI acceptance criteria
  for Cmax from 80% - 125% to 90% - 111%?
  
  No - only for AUC. See 'Questions & Answers: Positions on specific questions addressed to
  the Pharmacokinetics Working Party', A#7 (pp15-16, Feb 2012).
  http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002963.pdf
  
  'The EWP recommends that the bioequivalence acceptance criteria for tacrolimus should be
  [90-111%] for AUC and [80-125%] for Cmax.'
  
  Best regards,
  Helmut
  
  -
  Ing. Helmut Schuetz
  BEBAC - Consultancy Services for
  Bioequivalence and Bioavailability Studies
  Neubaugasse 36/11
  1070 Vienna, Austria
  e-mail  helmut.schuetz.aaa.bebac.at
  web     http://bebac.at/
  forum   http://forum.bebac.at/
  

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