2006D-0344
  

  
 Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Dr. Stephanie Hueber
  

  
Date & Time: 
  

  
09/26/2006 01:09:37
  



  

  
Organization : 
  

  
french health products safety agency
  



  

  
Category : 
  

  
Other Government
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I work on the assessment of drug-drug interaction and received last week the draft guidance  on  'Drug drug interaction studies' established by the Department of Health and Human Services. This Guidance for Industry is very interesting and also useful for Health Authorities. However, I would like to contact a  person who contributed to this work  in order to submitt him by queries regarding in vitro induction studies. Actually, I will be interested by references which lead to the conclusion drawn in the draft that the lack of CYP3A in vitro induction allows to conclude to the lack of other CYPs induction.  

Thanks very much for your help.

Best regards,

 

Stephanie Hueber