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June 26, 2020

Impact Story: Preclinical Research to Achieve Safer Prescribing of Psychoactive Therapeutics for Patients Who Use Opioids

The risk of death from opioid use can be greatly increased when patients are taking other, non-opioid psychoactive therapeutics with sedative properties. To support safer labeling […]
June 26, 2020

Impact Story: Capturing Patient Experience Through Deep Learning

CDER researchers are developing methods based on deep learning, a kind of artificial intelligence (AI), to capture patient experience of medical products in a way that […]
June 26, 2020

Impact Story: A Flexible Clinical Trial Design Suitable for Emerging Disease Outbreaks

A New Trial Design for a Medical Emergency CDER statisticians and their collaborators at NIH and in West Africa faced the challenge of designing a trial […]
June 26, 2020

Impact Story: Evaluating the Potential of Microengineered Human Cellular Systems to Predict Drug Effects in the Clinic

CDER researchers are developing systems that allow for replication of human physiology and better prediction of drug effects before the initiation of clinical trials. These systems […]
June 26, 2020

Impact Story: Transitioning a Powerful Analytical Tool into Manufacturing to Improve the Quality of Complex Therapeutics

CDER researchers are evaluating an approach that would harness the potential of mass spectrometry to ensure the quality of complex protein therapeutics to treat cancer and […]
June 26, 2020

Impact Story: Supporting Drug Development Through Physiologically Based Pharmacokinetic Modeling

CDER clinical pharmacologists are helping the drug development community use computational models to achieve safe and effective dosing recommendations for patients who are taking more than […]
June 26, 2020

Impact Story: Determining the Clinical Benefit of Treatment Beyond Progression with Immune Checkpoint Inhibitors

CDER researchers are evaluating whether it is clinically beneficial to treat cancer patients with checkpoint inhibitors if their tumors do not immediately shrink in response to […]
June 26, 2020

Impact Story: Using innovative statistical approaches to provide the most reliable treatment outcomes information to patients and clinicians

Using Bayesian hierarchical models, CDER statisticians are improving our understanding of how drugs affect different groups of patients. When evaluating drug treatments, determining how and to […]
June 26, 2020

Curativa Bay Corporation – 608406 – 06/25/2020

Product: Drugs Recipient: Recipient Name William J. Maher Curativa Bay Corporation 4707 140th Avenue N, Suite 210Clearwater, FL 33762United States [email protected] This is to advise you […]
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