PharmPK Discussion - Transdermal delivery

• On 18 Jul 2013 at 08:42:30, Benedicte SHEVCHENKO sent the message
  

  
  Dear All
  
  Could someone help me?
  
  For a dermal absorption studies, the SCCS opinion indicated  the following decision  (agreed during
  the 7th Plenary Meeting of 22 June 2010): “for a reliable dermal absorption study, 8 skin samples
  from at least four donors should be used. "
  
  This sentence leads to controversial discussions: For some it means that at least 2 skin samples/
  donor should be used. With 4 donors, that would result in 8 samples in total per condition.
  While for others it meansn that  8 skin explants should be used from each one of the 4 donors (8
  samples/donor). This would result in 32 samples in total per condition
  
  Which option is the correct one?
  
  Thank you in advance
  
  Kind regards
  
  Benedicte SHEVCHENKO
  
  

  Back to the Top

• On 18 Jul 2013 at 09:30:06, Katie Chan sent the message
  

  
  Based on the sentence structure, my opinion:
  
  8 skin samples is the primary requirement.
  Based on this primary requirement, the following condition must be followed: from at least four
  donors
  
  Acceptable option #1: Donor 1, 2, 3, 4 (2 samples each)
  Acceptable option #2: Donor 1, 2, 3, 4, 5 (1 sample each) + Donor 6 (3 samples)
  Acceptable option #3: Donor 1, 2, 3, 4, 5, 6, 7, 8 (1 sample each)
   Un-acceptable option #1: Donor 1 (3 samples) + Donor 2 (4 samples) + Donor 3 (1 sample)
  Un-acceptable option #2: Donor 1 (4 samples) + Donor 2 (4 samples)
  
  Regards,
  Katie
  
  

  Back to the Top

• On 18 Jul 2013 at 10:06:42, Jean PACHOT sent the message
  

  
  I fully agree with Katie. You should use at least 4 different donors, whatever the number of samples
  per donor is (the number of samples per donor is equal or superior to 1 sample). The total number of
  samples should be equal or greater than 8 these samples are derived from at least 4 donors.
  Regards
  Jean
  
  Jean PACHOT, President & CSO
  Oroxcell SAS
  www.oroxcell.com
  Parc technologique Biocitech
  102, Avenue Gaston Roussel
  F-93230, Romainville
  jean.pachot.at.oroxcell.com
  
  

  Back to the Top

• On 20 Jul 2013 at 14:48:27, Jos Bessems sent the message
  

  
  Dear Benedicte,
  
  Option 1 is the correct option. See SCCS opinion, page 12, 4th paragraph of conclusions
  
  http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_002.pdf
  
  The phrase 'at least' is not mentioned in the 4th paragraph so 8 samples in total is sufficient.
  
  Regards,
  
  Jos
  
  

  Back to the Top

Copyright 1995-2014 David W. A. Bourne (david@boomer.org)