1.

What Are The Reasons For Failure Of Different Phases Of Trials?

Answer»

Reasons for failure of Phase I trials:

  1. Pre-clinical ANIMAL models not equal to behavior in humans
  2. Inadequate pre-clinical data
  3. CHANGE in drug formulation from pre-clinical testing to clinical testing
  4. PK/PD relationship
  5. POORLY designed clinical studies
  6. Drug too toxic in humans

Reasons for failure in phase II and Phase III trials:

  1. Infrequent ADR s
  2. Drug-drug interaction
  3. Drug-disease interaction 
  4. GENETIC
  5. Effectiveness insufficient
  6. Economic

Reasons for failure of Phase I trials:

Reasons for failure in phase II and Phase III trials:


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