Conventional manual patch clamp measurements of the concentration-response relationship in ion channels stably expressed in mammalian cells provide IC50 values for IND-enabling, cardiac risk evaluation.
Concentration verification via chemical analysis of dosing formulations strengthens the accuracy and thoroughness of nonclinical cardiac safety studies. DFA is a requirement for GLP studies submitted in an IND dossier.
GLP hERG (IKr)
Required for IND submissions
Quantitative assessment of inhibitory potency
Physiological temperature standard
Additional GLP ion channel assays include Cav1.2 (ICa,L), Nav1.5 (INa), Kv1.5 (IKur), Kv4.3 (ITO), KvLQT1/minK (IKs).
Dose Formulation Analysis (DFA)
Same-day DFA and hERG analysis
HPLC with UV detection