The Safety Pharmacology Society is pleased to invite you to a webinar presentation on Thursday, April 25, 2019 at 11:00 ET, 16:00 GMT/ 17:00 CET.
Title: Concordance of Respiratory Safety Pharmacology Findings and Translation to Clinical Adverse Effects
Presenter: Sabina Paglialunga, PhD, Celerion, and Greg Friedrichs, PhD, Novartis
Abstract: The ICH S7A guidelines which include respiratory safety pharmacology studies as part of core battery testing for most new molecular entities have been in place for nearly two decades. During this period, several questions have risen regarding the effectiveness of these in vivo respiratory assessments to identify a potential clinical concern. Specifically, are safety pharmacology respiratory endpoints sufficient to detect drug liability? How well do preclinical studies predict human risk? To address these questions, the following presentation will briefly review preclinical models and assessments to evaluate a drug’s effect on the respiratory system; describe the statistical analyses to examine preclinical-clinical concordance; and summarize results from published concordance studies.
Moderator: Simon Authier, DVM, MBA, PhD, DSP, Director Safety Pharmacology, Citoxlab
We look forward to your participation.
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