2004N-0432 - Radioactive Drugs for Certain Research Uses; Public Meeting
  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  

  



  

  
Submitter : 
  

  
Dr. Bradley Christian
  

  
Date & Time: 
  

  
12/15/2004 01:12:46
  



  

  
Organization : 
  

  
Kettering Medical Center
  



  

  
Academia
  


  

  
Category : 
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Re: RDRC Membership Issue #1



I do not feel the RDRC would benefit by requiring the membership of a pharmacologist or toxicologist.  Given that radiotracer doses, by definition, do not cause a clinically detectable effect, the expertise of such an individual would be useless.  From a logistical standpoint, pharmocologists and toxicologists  are typically not active in the development of radiopharmaceuticals.  As a result, most academic research centers do not have access to such individuals and the prospect of finding a willing pharmacologist / toxicologist with experience in radiotracer development is unlikely.



A better option would be to set a lower injected mass limit, as discussed at the public forum.