Results 111 to 120 of about 3,641 (145)
Venous Thromboembolism Risk Associated With Relugolix-estradiol-norethisterone Acetate Combination Therapy. [PDF]
J Endocr SocDouxfils J +6 more
europepmc +1 more source
Application of Language Models for the Analysis of Adverse Drug Events in Pharmaceutical Research and Development: Scoping Review. [PDF]
JMIR AISchreier O +6 more
europepmc +1 more source
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Active Surveillance of Postmarket Medical Product Safety in the Federal Partners' Collaboration
Medical Care, 2012After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they ...
Melissa A, Robb +5 more
openaire +2 more sources
Evaluation of the Relative Abuse of an OROS Extended-release Hydromorphone HCI Product
The Clinical Journal of Pain, 2018Objective: Formulating prescription opioids to limit abuse remains a priority. OROS extended-release (ER) hydromorphone HCl (EXALGO) may have lower abuse potential than many other opioid products. Three postmarketing studies of the relative abuse liability of OROS hydromorphone ER were conducted.
Butler, Stephen F. +3 more
openaire +3 more sources
Canadian Journal of Physiology and Pharmacology, 2007
Postmarket surveillance, particularly adverse reactions (ARs), forms an integral part of the ongoing safety evaluation for natural health products (NHPs). ARs can be related to many factors, including inherent toxicity, misuse, hypersensitivity, NHP–drug interactions, or product quality.
openaire +1 more source
Postmarket surveillance, particularly adverse reactions (ARs), forms an integral part of the ongoing safety evaluation for natural health products (NHPs). ARs can be related to many factors, including inherent toxicity, misuse, hypersensitivity, NHP–drug interactions, or product quality.
openaire +1 more source
Canadian journal of physiology and pharmacology, 2008
Postmarket surveillance, particularly adverse reactions (ARs), forms an integral part of the ongoing safety evaluation for natural health products (NHPs). ARs can be related to many factors, including inherent toxicity, misuse, hypersensitivity, NHP-drug interactions, or product quality. High consumer use and limited safety and efficacy data from human
openaire +1 more source
Postmarket surveillance, particularly adverse reactions (ARs), forms an integral part of the ongoing safety evaluation for natural health products (NHPs). ARs can be related to many factors, including inherent toxicity, misuse, hypersensitivity, NHP-drug interactions, or product quality. High consumer use and limited safety and efficacy data from human
openaire +1 more source
Postmarket sequential database surveillance of medical products
2013This dissertation focuses on the capabilities of a novel public health data system - the Sentinel System - to supplement existing postmarket surveillance systems of the U.S. Food and Drug Administration (FDA). The Sentinel System is designed to identify and assess safety risks associated with drugs, therapeutic biologics, vaccines, and medical devices ...
openaire +1 more source
Postmarket surveillance and returned product analysis: Success but not transparency
Heart Rhythm, 2013Jonathan P, Piccini, Robert M, Califf
openaire +2 more sources