CiPA LAB

Recommended Cardiac Ion Channel Protocols Under CiPA by FDA (www.cipaproject.org)

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As it is anticipated that nonclinical ion channel data will play an important role for regulatory decision-making in drug development programs, standardized protocols are recommended. This document contains detailed protocol recommendations for hERG, CaV1.2, and NaV1.5 channel studies. These recommendations are based on current knowledge, hence are expected to evolve over time. The document is time-stamped. We encourage you to verify with the Agency prior to initiating the studies to ensure that the document you have is up-to-date and to clarify questions including which protocol(s) to test for a specific drug. Access the protocols at: https://www.fda.gov/media/131157/download