Investigational - PowerPoint PPT Presentation

Learn about the diagnosis, screening needs, and indications for liver transplant evaluation in patients with cirrhosis. No financial relationships or discussion of off-label medication use or investigational drugs.

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Explore Zilebesiran, an investigational RNA interference therapeutic targeting hepatic AGT synthesis for hypertension. Primary findings from Phase 2 trial KARDIA-1 reveal sustained blood pressure reduction. Addressing the unmet need for innovative antihypertensive treatments.

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The content provides an overview of the IRB review process for research studies, including what necessitates IRB review, the levels of IRB review (exempt, expedited, full board), examples of full board research, and criteria for an Investigational New Drug.

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Providing guidance on types of Expanded Access for drugs, biologics, and devices, this content explains the concept of Expanded Access and the criteria that must be met. It covers different types of Expanded Access for drugs and devices, emphasizing the importance of patient safety and benefit. The

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The Food and Drug Administration (FDA) plays a crucial role in regulating research, manufacturing, marketing, and distribution of medical devices. Medical devices are classified based on risk and intended use, with three main categories determining regulatory pathways. The classification system help

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Drug regulation involves controlling drug use through international agreement authorities like the FDA, EMA, and PMDA. The FDA plays a crucial role in drug evaluation and research, biologic evaluation, devices, and food safety. There are various types of applications for drug approval, along with a

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An Investigational New Drug Application (INDA) is a crucial submission to the FDA for permission to conduct clinical studies on new drug products. It plays a pivotal role in assessing the safety and efficacy of new drugs before they can be marketed and distributed for human use. This article covers

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Investigational products play a crucial role in clinical trials, encompassing drugs, devices, biologics, and more. The FDA defines investigational new drugs as substances seeking approval, even if previously in use, with potential changes. Similarly, investigational devices are those under investiga

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Explore Epic tools for clinical research developed by Shara Power, a skilled application developer specializing in EPIC Beacon Oncology at UIHC Healthcare Information Systems. Learn about managing research study records, investigational study medication orders, and the process for creating and using

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Master protocols, seamless trials, and adaptive designs are revolutionizing oncology drug development. These innovative approaches involve multiple substudies with different objectives, evaluating investigational drugs across disease subtypes. Basket trials and umbrella trials offer flexibility in s

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This content discusses the access to investigational drugs outside of clinical trials, highlighting Treatment Use Criteria and Emergency Use situations. It covers Subpart E regulations, including the definition of life-threatening and severely-debilitating illnesses. The importance of safeguards lik

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Explore the event highlights at the Quebec City Convention Center from November 20-24, 2024, featuring insightful sessions, important disclosures, and engaging speakers. Uncover financial relationships, investigational uses, and more through captivating visuals.

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Investigational products play a crucial role in clinical trials, encompassing drugs, devices, and biologics that undergo testing to ensure compliance with protocols and participant safety. This comprehensive guide covers the definitions, regulations, and accountability of investigational products in

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