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A Proof of Concept study is a trial to demonstrate clinical efficacy with a small number of strictly selected patients.

The objectives of the Proof of Concept Study:

  • Validation of the relevance of novel therapeutic targets and in vivo preclinical models to man. 
  • Define potential biological markets for clinical efficacy or toxicity. 
  • Provide earlier evidence of the potential to show clinical efficacy. 
  • Rapidly eliminate potential failures from the pipeline. 
  • Provide an assessment of the commercial potential of NCE development candidates.

It is essential to have well defined criteria for decision-making at all stages of the R&D process. This is particularly true for those that will result in a NO GO decision.

Potential GO/NO GO Decision criteria:

  • Safety 
  • Tolerability 
  • Bioavailability/Pharmacokinetics (PK) 
  • Biopharmaceutics 
  • Pharmacodynamics (PD) 
  •     Duration of action 
  •     Relationship between Dose and PD 
  • Efficacy 
  • Patient acceptability 
  • Commercial viability in the indication at potential time of launch

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