Publications by authors named "Mitra Ahadpour"
Background: The use of patient health and treatment information captured in structured and unstructured formats in computerized electronic health record (EHR) repositories could potentially augment the detection of safety signals for drug products regulated by the US Food and Drug Administration (FDA). Natural language processing and other artificial intelligence (AI) techniques provide novel methodologies that could be leveraged to extract clinically useful information from EHR resources.
Objective: Our aim is to develop a novel AI-enabled software prototype to identify adverse drug event (ADE) safety signals from free-text discharge summaries in EHRs to enhance opioid drug safety and research activities at the FDA.
Article Synopsis
- - The study aims to improve evidence-based guidelines for prescribing opioid analgesics in treating acute non-cancer pain, focusing on the experiences of 1550 opioid-naïve participants from various clinical settings.
- - Participants will be monitored for 6 months through a health data platform that collects information from multiple sources, including surveys, healthcare records, and activity trackers, to analyze pain management and opioid usage patterns.
- - Ethical approval has been granted for the study, and findings will be shared with participants, researchers, and the public to enhance understanding of pain treatment outcomes and guidelines.
In the regulatory setting, clinical pharmacology focuses on the impact of intrinsic and extrinsic factors on inter-patient and intra-subject variability in drug exposure and response. This translational science contributes to the understanding of the benefit-risk profile in individual patients and the development of relevant therapeutic monitoring and management strategies. Clinical pharmacology also plays a major role in the development and qualification of drug development tools.
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