Overview

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