GLP HERG Testing

According to the ICH S7A and ICH S7B guidelines all compounds under consideration for Investigational New Drug (IND) applications need to be tested for HERG interaction in compliance with GLP principles. B'SYS offers complete GLP IC₅₀ determination with at least 4 test concentrations (n=3). Please contact B'SYS to initiate HERG GLP study project:

Phase 1:	Agreement for HERG GLP study accomplishment Characterization of test item by sponsor with B'SYS datasheet Completion of draft GLP Study Plan for review by sponsor Following sponsors consent Study Plan is reviewed by B'SYS QAU Shipment of test item and activation of Study Plan
Phase 2:	Experimental Study start Study specific inspection of laboratory work by B'SYS's QAU Experimental Study completion Collection of raw data and analysis Review of results by Study Director Draft Study Report for sponsor‘s review
Phase 3:	QAU review of Study Report Finalization of Study Report by Study Director Study Report shipment to sponsor: Original or Copy Archiving of GLP Study records and final report

Test item quantity: Approximately 30mg are sufficient for small molecules

Study schedule: Results reported 1 week after experimental starting date

GLP HERG test system	Test concentrations	Vehicle treatment	Positive control
CHO HERG	typ. 3, 10, 30, 100µM	DMSO, WFI, PBS,	E-4031
HEK HERG	or depending on solubility	EtOH,...	E-4031