Toronto, Canada (PRWEB) October 03, 2012
The single most frequent reason for safety-related drug withdrawal is organ toxicity. Although drug-induced liver injury (DILI) tops the list of potential causes, kidney and other organ toxicities are also of major concern for drug developers, particularly because they can have significant and serious impact when discovered in the post-marketing phase.
But what are the best ways to incorporate and monitor these types of safety parameters in your clinical trial?
Join our panel from ACM Global Central Laboratory, featuring Mark Engelhart, Chief Commercial Officer, Andrew Botham, PhD, Research & Development Manager, and Maria-Magdalena Patru, MD, PhD, Scientific Affairs Medical Liaison, as they examine the operational and analytical considerations for early detection of potential organ toxicity, including:
- Operational considerations and best practice standard operating procedures for specimen collection, handling, and shipping to ensure sample and ultimately test result integrity.
- Development of improved strategies that can identify early signs of potential drug-induced organ toxicity (DIOT) and understanding the rules that can help predict severe organ injury.
- Development of patient assessment indicators to identify underlying factors and etiologies that may impact or cause observed patterns of test results apart from drug induced toxicity.
- Integrating organ toxicity surveillance into clinical trial design and protocol development.
- Developing flexible safety biomarker panels in collaboration with your central lab, in which available biomarkers testing, best suited for the study, will be offered.
When considering the latest regulatory guidance on organ toxicity, and the increased availability of effective biomarkers, drug developers have the opportunity to adopt a more proactive strategy for assessing a drug’s adverse effect on vital organs.
This webinar is part of ACM Global’s “Navigating Global Clinical Trials with your Central Lab” series of informative and interactive events. For more information or to register go to http://xtks.in/xto-529
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