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The Potential to Leverage Real-World Data for Pediatric Clinical Trials: A Proof-of-Concept Study.
J Med Internet ResDeclerck J +12 more
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IL‐17 Inhibitors and Inflammatory Bowel Diseases: A Postmarketing Study in Vigibase
Clinical pharmacology and therapy, 2021Several gastrointestinal symptoms and chronic inflammatory bowel diseases (IBDs) have been reported after therapy with IL‐17 inhibitors. To date, however, no study has shown a clear association between these drugs and IBD onset.
N. Petitpain +6 more
semanticscholar +1 more source
Pharmaceutical regulations in Iraq: from medicine approval to postmarketing.
Eastern Mediterranean health journal = La revue de sante de la Mediterranee orientale = al-Majallah al-sihhiyah li-sharq al-mutawassit, 2021Background Recent information on regulation of the pharmaceutical sector in Iraq is scarce. Aims This report summarizes the regulations governing pharmaceutical products in Iraq, assesses the challenges faced and makes recommendations to tackle these ...
A. A. Al-Jumaili +4 more
semanticscholar +1 more source
Postmarketing Drug Surveillance
JAMA: The Journal of the American Medical Association, 1984To the Editor.— We concur with Rossi et al 1 that alert physicians and others spontaneously reporting their suspicions of adverse drug reactions is critical to the discovery of rare effects of marketed drugs. Spontaneous reporting is an essential element of the multicomponent postmarketing surveillance systems established by pharmaceutical ...
Jacqueline S. Gardner +3 more
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JAMA: The Journal of the American Medical Association, 1979
THERE is a general but strongly held view that, after drugs are marketed, additional epidemiologic information is needed on their clinical effects, particularly adverse effects. This notion is based soundly on the limited size and scope of the clinical experience with a drug before marketing.
Hershel Jick +2 more
openaire +3 more sources
THERE is a general but strongly held view that, after drugs are marketed, additional epidemiologic information is needed on their clinical effects, particularly adverse effects. This notion is based soundly on the limited size and scope of the clinical experience with a drug before marketing.
Hershel Jick +2 more
openaire +3 more sources
Review of Transporter‐Related Postmarketing Requirement or Postmarketing Commitment Studies
The Journal of Clinical Pharmacology, 2016AbstractThe objectives of this report are to summarize the content and status of transporter‐related postmarketing requirement (PMR)/postmarketing commitment (PMC) studies in new drug applications (NDAs) approved by the U.S. Food and Drug Administration (FDA) and to discuss the reasons for requesting such studies and the impact of PMR/PMC study results
Sheetal Agarwal +5 more
openaire +3 more sources
Annals of Internal Medicine, 2019
Background Use of sodium-glucose cotransporter-2 (SGLT2) inhibitors has been associated with Fournier gangrene (FG), a rare urologic emergency characterized by necrotizing infection of the external genitalia, perineum, and perianal region. Objective To
S. Bersoff-Matcha +4 more
semanticscholar +1 more source
Background Use of sodium-glucose cotransporter-2 (SGLT2) inhibitors has been associated with Fournier gangrene (FG), a rare urologic emergency characterized by necrotizing infection of the external genitalia, perineum, and perianal region. Objective To
S. Bersoff-Matcha +4 more
semanticscholar +1 more source
2011
Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time. Such surveillance is much more likely to detect previously unrecognized positive or negative effects that may be associated with ...
Vera, Vlahović-Palčevski +1 more
openaire +2 more sources
Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time. Such surveillance is much more likely to detect previously unrecognized positive or negative effects that may be associated with ...
Vera, Vlahović-Palčevski +1 more
openaire +2 more sources
An evaluation of statistical approaches to postmarketing surveillance
Statistics in Medicine, 2020Safety of medical products presents a serious concern worldwide. Surveillance systems of postmarket medical products have been established for continual monitoring of adverse events (AEs) in many countries, and the proliferation of electronic health ...
Yuxin Ding, M. Markatou, R. Ball
semanticscholar +1 more source