PharmPK Discussion - Biowaiver for solution

• On 13 May 2009 at 09:57:46, "Mulla Hussain - Paediatric Medicines Research" (hussain.mulla.-at-.uhl-tr.nhs.uk) sent the message
  

  
  Dear All
  
  Please accept my apology in advance for asking a simple question, but
  I am not clear on this issue and am certainly not an expert in this
  field.
  
  If I am developing a new IR solution formulation for a drug which is
  BCS Class 1 or 3, and which has previously only been marketed as an IR
  solid oral dosage form, is it acceptable to apply for a biowaiver? All
  the regulatory documents I have looked at only talk about solid oral
  dosage forms.
  
  thanks
  
  Hussain Mulla
  
  

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• On 14 May 2009 at 10:22:00, Manoj Kumar Paruthi (ManojP.-at-.Hikma.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear Hussian,
  
  Solutions are waived for BE study requirements as they are deemed
  bioequivalent. The reason is that there are no formulation variables
  to play any role
  
  Manoj K. Paruthi, Ph.D.
  Head of R&D
  Hikma Pharmaceuticals PLC
  
  

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• On 15 May 2009 at 05:00:02, "Zafar Iqbal , Prof Dept of Pharmacy UOP Iqbal" (zafar_iqbal.-at-.upesh.edu.pk) sent the message
  

  
  Dear Hussain,
  If drug is stable in solution then I think it is acceptable as
  biowaiver.
  
  DR Zafar
  
  

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