PharmPK Discussion - Phase I or phase 1

• On 10 Mar 2011 at 15:58:13, Toufigh Gordi (tgordi.aaa.yahoo.com) sent the message
  

  
  Hi,
  
  I have seen different naming conventions for clinical studies. Which one  is the "correct" one? Or are they interchangeable?
  
  Toufigh
  
  Toufigh Gordi, PhD
  President, PK/PD and Clinical Pharmacology Services
  Rosa & Co. LLC (www.rosaandco.com)
  E-mail: tgordi.at.rosaandco.com
  
  [Phase one - db]
  
  

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• On 11 Mar 2011 at 12:07:31, Frank Bales (frankbales.aaa.msn.com) sent the message
  

  
  Toufigh,
   An FDA Guidance for "Phase 1" is
   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation /guidances/ucm070273.pdf
   Similarly there is a Guidance for "Phase 2 and Phase 3":
   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation /Guidances/ucm070567.pdf
   However the other naming convention does appear in literature cited by  the FDA.
   So I guess, either will work, but "Phase 1" is preferred.
  
  Regards,  Frank Bales, Ph.D.
  
  

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