Cardiovascular Safety Pharmacology: Best Practice Considerations for…

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Register for this webinar to understand how the in vivo QTc assay fits within the ICH guidelines, and how CV safety pharmacology study models are validated and verified.

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.

The first segment of 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. In the second segment of this webinar, they will discuss exposure-response (ER) analysis, or pharmacokinetic/pharmacodynamic (PK/PD) analysis of cardiovascular telemetry data. Concentration QTc (C-QTc) analysis has been proposed as a valid alternative to the conventional approach which combines PK exposure and PD response data. The speakers will also discuss power analysis (detection sensitivity) and its role in assessing study quality.

Register for this webinar to understand how the in vivo QTc assay fits within the ICH guidelines, and how CV safety pharmacology study models are validated and verified.

Join Ty Speece, BS, Safety Pharmacology, Inotiv; and Joel Baublits, MS, Director of Operations, Cardiovascular Analytics, for the live webinar on Monday, December 13, 2021 at 1pm EST.

For more information, or to register for this event, visit Cardiovascular Safety Pharmacology: Best Practice Considerations for the In Vivo QTc Core Assay.

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