PharmPK Discussion - Placebo in Pharmacodynamic Bioequivalence study

• On 6 Dec 2011 at 18:46:18, narasimha reddy (r.nara.simha.reddy123.at.gmail.com) sent the message
  

  
  Hi PharmPK members,
  
  Whether Placebo is permitted in Pharmacodynamic Equivalence studies?
  
  Narasimha Reddy
  
  

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• On 7 Dec 2011 at 06:47:36, "Prof. Dr. Zafar Iqbal" (zafar_iqbal.at.upesh.edu.pk) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear Narasimha,
  In Bioequivalence studies the response is compared with the reference
  drug that is not possible with the reference drug. therefore, the
  reference drug is used for comparison.
  
  Dr Zafar
  
  

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• On 7 Dec 2011 at 03:20:33, (rajamohameds.-a-.orchidpharma.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Since there is no drug, Placebo can not be considered for pharmacodynamic analysis
  

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• On 7 Dec 2011 at 04:34:59, (rajamohameds.at.orchidpharma.com) sent the message
  

  
  Dear Narashmha,
  
  In bio equivalence testing two products are compared for pharmacokinetic and
  pharmacokinetic analysis.
  
  Placebo is used in clinical trials of NDA or NCE studies.
  
  But in some exceptional cases for example nasal products and transdermal patches, placebo
  is given to test the dynamic efficacy - however others can comment on this
  
  Regards
  Dr. Raja Mohamed
  Orchid Healthcare
  

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• On 7 Dec 2011 at 10:06:50, (sundaramurugesan.aaa.lupinpharma.com) sent the message
  

  
  Dear Mr. Reddy
  
  As per my knowledge, Placebo in Pharmacodynamic Bioequivalence study can be done, for
  further details refer Mesalamine Suppository BE recommendations.
  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm081327.htm
  
  Thanks and Regards,
  
  Sundar
  
  

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• On 7 Dec 2011 at 21:29:59, "DR.GUNA SAKARAN" (drgunasakaran.-at-.gmail.com) sent the message
  

  
  Dear Mr.Narasimha,
  
  YES. Placebo is allowed in Pharmacodynamic Bioequivalence study.
  
  In instances where an important placebo effect can occur, comparison
  between
  pharmaceutical products can only be made by a prior consideration of the
  placebo
  effect in the study design. This may be achieved by adding a third phase
  with
  placebo treatment in the design of the Pharmacodynamic Bioequivalence
  study.
  
  Reference: Bioequivalence Requirements Guidelines, Kingdom of Saudi
  Arabia
  Saudi Food and Drug Authority, Drug Sector, May 2005. Page 24. Point no
  - 6.
  
  Regards,
  Dr.S.Gunasakaran, MD
  Head - Clinical Research & Medical Affairs
  
  

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