Results 131 to 140 of about 6,606,497 (285)
Post-Marketing Surveillance [PDF]
Journal of the Royal Society of Medicine, 1979 openaire +1 more source
Digital Transformation of Medicines Regulation in Africa—Perspectives from a Stakeholder Convening
Clinical Pharmacology &Therapeutics, EarlyView.Regulatory authorities worldwide are developing strategies to integrate artificial intelligence (AI) into the lifecycle of health products, technologies, and medicines. While regulators share goals of improving efficiency, strengthening decision‐making, and protecting public health, their approaches differ according to institutional structures ...
Christelna Reyneke +12 more
wiley +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.When setting the price of cell and gene therapies in Japan, the factors considered include the manufacturing and operating costs of the new drug or a comparator, leading to discrepancies between price and values, in particular those specific to cell and gene therapies.
Akina Takami, Ataru Igarashi
wiley +1 more source
Long‐Acting Therapeutics in Pediatric Health: Bridging Innovation and Access
Clinical Pharmacology &Therapeutics, EarlyView.Children have distinct therapeutic needs arising from age‐dependent physiology, disease epidemiology, formulation requirements, dosing considerations, and safety vulnerabilities. Despite substantial reductions in childhood mortality over the past three decades, nearly 5 million children under five died in 2023, with infectious diseases continuing to ...
Prajith Venkatasubramanian +5 more
wiley +1 more source
"Living in the File": Kinship & Political Surveillance in Post-Civil War Greece
, 2017 Little attention has been paid to the ways in which political surveillance practices have historically intersected with a cultural logic of kinship or actual kin relationships, despite the fact that intergenerational effects of state surveillance have ...
Pendakis, Katherine
core +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.Accurate identification of medicines used in adverse event reports is crucial for effective postmarketing safety surveillance. The US Food and Drug Administration's (FDA) four‐letter suffix naming convention was designed to facilitate accurate biological product identification, but the extent to which these suffixes have been incorporated into ...
Danijela Stojanovic +3 more
wiley +1 more source
Post‐marketing surveillance in the UK (1984). [PDF]
British Journal of Clinical Pharmacology, 1986 openaire +2 more sources
Clinical Pharmacology &Therapeutics, EarlyView.Although sodium‐glucose cotransporter‐2 inhibitors (SGLT2i) are recommended for patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD), concerns regarding urogenital infections persist. Therefore, we evaluated the risk of urinary tract infection (UTI) and genital tract infection (GTI) after SGLT2i initiation in this population ...
Young‐Mi Ah +4 more
wiley +1 more source
Considerations for the Integration of Clinical Trials and Real‐World Data
Clinical Pharmacology &Therapeutics, EarlyView.As clinical decision‐making increasingly moves toward individualized and context‐specific treatment recommendations, reliance on any single evidence source, randomized or observational, may be insufficient. Principled integration of randomized controlled trials and real‐world data, grounded in explicit causal frameworks, offers a path toward evidence ...
Sky Qiu +19 more
wiley +1 more source
Multilayered surveillance in Israel/Palestine: Dialectics of inclusive exclusion
, 2017 The paper examines the surveillance apparatuses in Israel/Palestine as mechanisms aiming to secure support for the Israeli regime, and to preserve its domination over the entire territory in dispute. We analyze three layers of surveillance: "exclusionary
Dayan, Hilla, Handel, Ariel
core +1 more source