Artificial Intelligence-Enabled Software Prototype to Inform Opioid Pharmacovigilance From Electronic Health Records: Development and Usability Study.

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.

Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine: Current Status and Emerging Trends.

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.

Mitochondrial oxidative stress and dysfunction induced by isoniazid: study on isolated rat liver and brain mitochondria.

Isoniazid (INH or isonicotinic hydrazide) is used for the treatment and prophylaxis of tuberculosis. Liver and brain are two important target organs in INH toxicity. However, the exact mechanisms behind the INH hepatotoxicity or neurotoxicity have not yet been completely understood.

Toxicity of valproic acid in isolated rat liver mitochondria.

Valproic acid (VPA), an anticonvulsant and mood-stabilizing drug, is widely used for the treatment of different types of seizures and myoclonic epilepsy. Several mechanisms have been suggested for VPA hepatotoxicity, and most of them are associated with oxidative stress. It seems that oxidative stress by VPA treatment has been associated with mitochondrial dysfunction.

Attention deficits disorder and drug abuse.

Recent research studies have attempted to explore various aspects of attention deficit disorder and substance abuser subtypes. The purpose of the present study is to evaluate the effect of drug abuse on MMPI scale score profiles of alcoholics with or without attention deficit disorder symptoms. For the alcoholic group with ADDRT versus the alcoholic group with ADDRT and drug abuse there were no significant differences between the groups.

Attention deficit disorder, alcoholism, and drug abuse: MMPI correlates.

Earlier research had demonstrated that alcoholics with attention deficit disorder residual type (ADDRT) differ from other alcoholics on the Minnesota Multiphasic Personality Inventory (MMPI). The purpose of this study was to explore the influence of drug abuse on the relationship of ADDRT and alcoholism as reflected on the MMPI. Groups of 48 male alcoholics, 28 ADDRT alcoholics, 25 ADDRT alcohol and drug abusers and 18 alcohol and drug abusers were all administered the MMPI.