Login     Register  
    Home  |   Your Profile  |   Search  |   About Us  |   Disclaimer  |   Pricing  |   Participating on CanBiotech
Can Biotech - BioPharma Portal and B2B Marketplace SMi’s 21st annual European Pharmaceutical Pricing & Reimbursement conference will address these latest developments and provide the ideal platform for payers and other decision makers from both public and private organisations, to benchmark with peers internationally and provide pharma companies with an invaluable insight into the decision making processes and approaches of these vital stakeholders. The two-day conference programme will help further your understanding and enable you to develop best practice approaches to such vital and common challenges, with the ultimate goal of encouraging innovation and improving patient access to novel and powerful medications.
Site Search:
    Home Innovation Community Patient Engagement CanBiotech™ Innovations Innovation Training Directory Events News Careers

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

Using the Site Privacy & Security Statement Advertise with us Directory Guide & Access Policy Event Postings CanBiotech Newsletters

© 2000-2015 CanBiotech™ Inc.