PharmPK Discussion - IT-only drug development

• On 16 Nov 2011 at 14:24:57, Paul Hutson (prhutson.-a-.pharmacy.wisc.edu) sent the message
  

  
  The following message was posted to: PharmPK
  
  An investigator here at UW
  has a drug candidate that he would like to try to develop further.  It
  is only an intrathecally-administered drug, and there is no similar drug
  with systemic administration to point to for animal tox/efficacy.  I
  note IT cytarabine and IT baclofen, as well as opioids and others (MTX,
  cortisone), but they already had systemic track records.
  
  I cannot find any guidances on the fda.gov site for developing IT drugs
  to advise him.  A CRO makes sense to help guide him, but does anyone
  have any suggestions on background reading or guidances for developing
  an IT-only drug that I can peruse and share with  him?
  Thank you
  Paul
  
  --
  Paul R. Hutson, Pharm.D.
  Associate Professor
  UW School of Pharmacy
  777 Highland Avenue
  Madison WI 53705-2222
  
  

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• On 16 Nov 2011 at 18:48:56, "Peggins, James (NIH/NCI) [E]" (pegginsj.-at-.mail.nih.gov) sent the message
  

  
  The following message was posted to: PharmPK
  
  Hi Paul,
  The NIH has a couple of programs designed to provide the kind of support your friend
  needs.  For cancer therapeutics the NCI has the NExT program.  Information can be found
  at:
  http://next.cancer.gov/
  
  For non-cancer indications the TRND program,
  http://nctt.nih.gov/TRND
  offers the same support.
  
  Regards,
  
  Jim Peggins
  
  --
  James O. Peggins, Ph.D.
  Toxicology & Pharmacology Branch
  NIH\NCI\DCTD\DTP
  6130 Executive Blvd
  

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