PharmPK Discussion - Similarity evaluation in Dissolution

• On 20 Feb 2007 at 14:32:03, "Tata, Prasad N" (Prasad.Tata.aaa.TycoHealthcare.com) sent the message
  

  
  I am comparing some dissolution profiles in various media.  I am
  wondering if any of you have any excel spread sheet or some program
  in which I can compute similarity factor between various formulations
  (test/ref and one strength Vs others) using Model dependent (power
  model, Bootstrap etc) or Model independent methods.
  Appreciate if you can share that information.
  
  Regards,
  Prasad
  Prasad NV Tata, Ph.D., FCP
  Manager-Pharmacokinetics
  Mallinckrodt, Inc.
  675 McDonnell Blvd.
  Saint Louis, MO 63134
  Tel: (314) 654-5325
  Fax: (314) 654-9325
  e-mail: prasad.tata.at.tycohealthcare.com
  
  

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• On 21 Feb 2007 at 11:38:10, "Ma Guangli" (guanglima.aaa.gmail.com) sent the message
  

  
  Dear Dr. Prasad,
       FDA accepts variation factor and similarity factor for
  dissolution profiles comparation.
  Variation Factor:
  F=(sigma(abs(R-T))/sigma(R))*100%
  Similarity Factor:
  F=50*log10((1+1/n*sigma(w*(R-T)^2))^-0.5 *100)
  R, ref; T, test; w, weight.
  
  Best regards,
  Guagnli Ma
  
  

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• On 21 Feb 2007 at 12:25:24, =?WINDOWS-1252?Q?M=E1ria_Duri=9Aov=E1?= (exfamadu.at.savba.sk) sent the message
  

  
  Dear Prasad NV Tata, Ph.D,
  
  a new approach to testing similarity of dissolution processes we
  described
  and exemplified in our study:
  DEDIK, L., DURISOVA, M.:  System-approach methods for modeling and
  testing  similarity of  in vitro dissolutions of  drug dosage
  formulations. Computer Methods and Programs in Biomedicine,  69,
  2002, 49-55.
  In the study we compared  outcomes, pros and cons of this approach
  with those of the common f_2 approach.
  A version of the CTDB software used in this study is available at our
  rather old, but still working, www site:
  http://www.uef.sav.sk/advanced.htm
  Using this software you can find a PowerPoint presentation of the use
  of this approach (Help, Lectures, Drug dissolution).
  
  With best regards
  Maria Durisova
  www.uef.sav.sk/durisova.htm
  
  

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