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The goal of cardiovascular safety pharmacology is to evaluate the effects of test substances on the most relevant parts of the cardiovascular system, to detect potentially undesirable effects, before engaging in clinical trials.
ICH guidelines provide information regarding best practices when designing and executing preclinical safety pharmacology studies. The in vivo QTc assay is used by the pharmaceutical industry to characterize the potential for delayed ventricular repolarization and is a core safety assay mentioned in ICH S7B guideline.
This webinar will focus on the specific components in the ICH guidelines and how to incorporate them into an IND-enabling cardiovascular telemetry study design. Key topics in this presentation include:
- How cardiovascular safety pharmacology study models are validated and verified
- How cardiovascular safety pharmacology studies are designed and executed
- Exposure-response analysis and understand how and why this might be incorporated into a preclinical study model
- Power analysis and understand why this is an important measurement when assessing the strength of a model to detect potential changes
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