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Overview

CRO expert in car­diac safety pharmacology

Safety Phar­ma­col­ogy defined in guide­line ICH S7A aims to assess poten­tial adverse effects of a test sub­stance on vital func­tions (car­dio­vas­cu­lar, res­pi­ra­tory and cen­tral ner­vous sys­tem are con­sid­ered as the vital organ sys­tems that should be stud­ied in the core bat­tery). The sub­se­quent ICH S7B focused on the assess­ment of the effects of phar­ma­ceu­ti­cals on ven­tric­u­lar repo­lar­iza­tion and proar­rhyth­mic risk.

Want to derisk your com­pound at an early stage?
Need help when select­ing your com­pounds at a pre­clin­i­cal satge?
Need to deter­mine early com­pounds able to induce QT prolongation?


Phys­ioS­tim has the rel­e­vant exper­tise to help you

Since 2000, Phys­ioS­tim – one of the European’s most reli­able CRO (Con­tract Research Organ­i­sa­tion) – has never ceased to improve its exper­tise in car­diac safety phar­ma­col­ogy. Indeed, PhysioStim’s experts offer elec­tro­phys­i­o­log­i­cal stud­ies, pre­clin­i­cal resources as well as their ded­i­cated exper­tise in answer­ing ICH S7A and S7B guide­lines in accor­dance with GLPs (Good Lab­o­ra­tory Prac­tices). Phys­ioS­tim there­fore offers a wide range of ser­vices and con­se­quently improves the qual­ity of work.

Safety Stud­ies Basics :

  • Sci­en­tif­i­cally valid meth­ods to be used
  • Safety phar­ma­co­log­i­cal stud­ies to be per­formed by a spe­cial­ized unit work­ing under GLP conditions