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. Dose formulation analysis (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
- Same-day DFA and hERG analysis
- HPLC with UV detection