Safety pharmacology methods and models in an evolving regulatory environment

Area of Science:

• Pharmacology
• Toxicology
• Drug Safety Assessment

Background:

• This editorial introduces the themed issue on safety pharmacology (SP) methods.
• Content is derived from the 2016 joint meeting of the Safety Pharmacology Society (SPS), Canadian Society of Pharmacology and Therapeutics (CSPT), and Japanese Safety Pharmacology Society (JSPS).

Discussion:

• The issue summarizes articles presented at the joint meeting relevant to SP.
• The field of SP is evolving with regulatory changes, including revisions to ICH-S7B guidance and the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative.
• There is a dynamic progression in SP with the characterization and implementation of alternative non-clinical safety models.

Key Insights:

• Novel method development and refinement are central to the current progress in SP.
• The integration of new safety models reflects the dynamic nature of the field.
• Regulatory shifts are driving innovation in SP methodologies.

Outlook:

• Continued evolution of regulatory guidance for non-clinical safety assessment.
• Implementation of new assays like CiPA for proarrhythmia risk assessment.
• Advancements in alternative non-clinical safety models will shape future SP practices.