Clinical protocol and design with PIP

dynakinclinicalprotocol_pip

 

 

Problem: Avoid long term efficacy / safety trials in children in hard to recruit situation

DK solution:

  • Propose model base bridging.
  • Design and write the protocol for adults and extension to PIP.
  • Use simple pilot trials, literature and modeling & simulation to leverage all mechanism of action related knowledge.

Result: High savings.