PharmPK Discussion - Scaled average bioequivalence

• On 5 Jan 2013 at 11:24:41, "V.G.S.Raghavendra Mamidi" (mamidi.ganesh.-at-.gmail.com) sent the message
  

  
  Dear Prasad,
  
  Different regulatories follow different procedures for Scaled
  Bioequivalence.
  
  And you can have a look for the following link for papers on SCABE:
  
  http://biostatisticsinbe.blogspot.in/2009_01_01_archive.html
  
  --
  Thank You,
  
  Regards,
  Raghavendra
  
  

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• On 13 Jan 2013 at 08:49:31, Laszlo Endrenyi (l.endrenyi.-at-.utoronto.ca) sent the message
  

  
  The following message was posted to: PharmPK
  
  A partial list of references:
  
  L. Tothfalusi, and L. Endrenyi. Limits for the scaled average
  bioequivalence of highly variable drugs and drug products. Pharm. Res.
  20: 382-389 (2003).
  
  V. Karalis, P. Macheras, and M. Symillides. Geometric mean
  ratio-dependent scaled bioequivalence limits with leveling-off
  properties. Eur. J. Pharm. Sci. 26: 54-61.
  
  S.H. Haidar, B. Davit, M.-L. Chen, et al. Bioequivalence approaches for
  highly variable drugs and drug products. Pharm. Res.15: 237-241 (2008).
  
  S.H. Haidar, F. Makhlouf, D.J. Schuirmann, et al. Evaluation of a
  scaling approach for the bioequivalence of highly variable drugs. AAPS
  J. 10: 450-454 (2008).
  
  L. Endrenyi and L. Tothfalusi. Regulatory conditions for the
  determination of bioequivalence of highly variable drugs. J. Pharm.
  Pharm. Sci. 12: 138-149 (2009).
  
  L. Tothfalusi, L. Endrenyi, and A. Garcia Areta. Evaluation of
  bioequivalence for highly variable drugs with scaled average
  bioequivalence. Clin. Pharmacokin. 48: 725-743 (2009).
  
  L. Tothfalusi and L. Endrenyi. Sample sizes for designing bioequivalence
  studies for highly variable drugs. J. Pharm. Pharm. Sci. 15: 73-84
  (2011).
  
  V. Karalis, M. Symillides, and P. Macheras. On the leveling-off
  properties of the new bioequivalence limits for highly variable drugs of
  the EMA guideline. Eur. J. Pharm. Sci. 44: 497-505 (2011).
  
  B.M. Davit, M.-L. Chen, D. Conner, et al. Implementation of a
  reference-scaled average bioequivalence approach for highly variable
  generic drug products by the US Food and Drug Administration. AAPS J.
  14: 914-924 (2012).
  
  Laszlo Endrenyi
  University of Toronto
  
  

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