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Research Services for Drug Development

 

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Case studies (Full Presentation, 1063Kb)

   

 

 

 

 Case I - a new class of anti-HIV drug

This human microdosing study took less than six months from inception to completion and examined the pharmacokinetics (PK) of the HIV inhibiting molecule in healthy subjects, following dosing with sub-pharmacological, microgram quantities of drug candidate.

                  

Results:

  • Study showed compound to be 100% bioavailable
  • Less expensive route than traditional IND;
  • Less than 6 months from start to report;
  • Highlights the pitfalls of extrapolation from animal studies;
  • Compound has been advanced to Phase 2 efficacy trials.