logo linkedin

CIPA Ini­tia­tive

logo CIPA

The envi­ron­ment of Safety Phar­ma­col­ogy is mov­ing on these last few years with the emer­gence of the new par­a­digm called CiPA Ini­tia­tive (Com­pre­hen­sive in-​vitro Proar­rhyth­mia Assay) in order to replace the cur­rent ICH S7B and ICH E14 guide­lines. This new strat­egy is pro­posed by expert work­ing groups from FDA (Food and Drug Admin­is­tra­tion), HESI (Health and Envi­ron­men­tal Sci­ences Insti­tute) and CSRC (Car­diac Safety Research Institute).

The CiPA path­way is com­posed of in-​vitro and in-​silico tech­nolo­gies to improve risk assessment.

The 3 main ele­ments of the CiPA initiative:

  • Assess­ment of drug effects on the main crit­i­cal human ven­tric­u­lar ion chan­nel cur­rents respon­si­ble of both the depo­lar­iza­tion and repo­lar­iza­tion process of the car­diac action potential.
  • The datasets obtained are used for in-​silico inte­gra­tion of the ion chan­nel effects to deter­mine the net effects on the car­diac action potential.
  • The last part is to check the out­come of in-​silico mod­el­ing results in a fully inte­grated bio­log­i­cal sys­tem like Human Induced Pluripo­tent Stem Cell Derived Ven­tric­u­lar Car­diomy­ocytes.

For more details, visit the CiPA web­site here

schma CIPA 2