Results 41 to 50 of about 2,472,934 (277)

Strategy for communicating benefit-risk decisions: A comparison of regulatory agencies’ publicly available documents

Frontiers in Pharmacology, 2014
The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia’s Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation ...
James eLeong Wai Yeen, Sam eSalek, Sam eSalek, Stuart eWalker, Stuart eWalker   +4 more
doaj   +1 more source

Impact of Engineered Nanomaterials on Health: Considerations for Benefit-Risk Assessment [PDF]

, 2011
Nanotechnology encompasses the design, characterisation, production and application of materials and systems by controlling shape and size at the nanoscale (nanometres).
Aebi, Ueli, Anklam, Elke, Baun, Anders, Donaldson, Ken, Fadeel, Bengt, Fears, Robin, Gehr, Peter, Kreyling, Wolfgang, Krug, Harald, Kuhlbusch, Thomas A. J., Monard, Denis, Riediker, Michael, Stamm, Hermann   +12 more
core   +1 more source

Lifestyle Behaviors and Cardiotoxic Treatment Risks in Adult Childhood Cancer Survivors

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Higher doses of anthracyclines and heart‐relevant radiotherapy increase cardiovascular disease (CVD) risk. This study assessed CVD and CVD risk factors among adult childhood cancer survivors (CCSs) across cardiotoxic treatment risk groups and examined associations between lifestyle behaviors and treatment risks.
Ruijie Li, Raquel Revuelta Iniesta, Alan R. Barker, Dimitris Vlachopoulos, Tomáš Sláma, Christina Schindera, Fabiën N. Belle   +6 more
wiley   +1 more source

PFAS in first-time mothers from Sweden: temporal trends and the impact from fish/seafood consumption and drinking water exposure

Environment International
Per- and polyfluoroalkyl substance (PFAS)-contaminated drinking water has been a significant source of human exposure to PFAS in Uppsala, Sweden. Herein, we investigated temporal trends of PFAS in serum samples collected three weeks after delivery from ...
Irina Gyllenhammar, Jonathan P. Benskin, Merle Plassmann, Martin Kruså, Philip McCleaf, Pernilla Hedvall Kallerman, Erik Lampa, Anders Glynn   +7 more
doaj   +1 more source

Structured benefit–risk evaluation for medicinal products: review of quantitative benefit–risk assessment findings in the literature

Therapeutic Advances in Drug Safety, 2020
A favorable benefit–risk profile remains an essential requirement for marketing authorization of medicinal drugs and devices. Furthermore, prior subjective, implicit and inconsistent ad hoc benefit–risk assessment methods have rightly evolved towards ...
Marie-Laure Kürzinger, Ludivine Douarin, Ievgeniia Uzun, Chantal El-Haddad, William Hurst, Juhaeri Juhaeri, Stéphanie Tcherny-Lessenot   +6 more
doaj   +1 more source

Benefit-risk assessment of vitamin D supplementation [PDF]

, 2018
Summary: Current intake recommendations of 200 to 600IU vitamin D per day may be insufficient for important disease outcomes reduced by vitamin D. Introduction: This study assessed the benefit of higher-dose and higher achieved 25-hydroxyvitamin D levels
Bischoff-Ferrari, H., Dawson-Hughes, B., Giovannucci, E., Hathcock, J., Shao, A., Willett, W.   +5 more
core  

The IUCN Red List of Ecosystems: motivations, challenges, and applications [PDF]

, 2015
In response to growing demand for ecosystem-level risk assessment in biodiversity conservation, and rapid proliferation of locally tailored protocols, the IUCN recently endorsed new Red List criteria as a global standard for ecosystem risk assessment ...
Adler, Akçakaya, Alvarez-Filip, Austin, Boitani, Brooks, Burgman, Burns, Butchart, Cardinale, Carwardine, Costanza, Council of the European Communities, Dallimer, Einstein, Estes, Faber-Langendoen, Folke, Gaston, Gorrod, Green, Hobbs, Hobday, Hooper, IUCN, Jennings, Jerde, Keith, Keith, Keith, Keith, Keith, Knapp, Kontula, Kuczera, Lester, Levins, Lindenmayer, Lindgaard, Mace, Mackey, Mant, Margules, Marshall, Martin, May, Micklin, Nicholson, Nicholson, Noss, Pisanu, Plagányi, Preston, Ramirez-Llodra, Regan, Republic of South Africa, Riecken, Rodrigues, Rodriguez, Rodriguez, Rodrıguez, Sabo, Schmitz, Scott, Sutherland, Tozer, Weston, Wiens, Williams, Wunder   +69 more
core   +2 more sources

Cerebrospinal Fluid Liquid Biopsy Enables Targeted Therapy Without Tissue Diagnosis in Pediatric Low‐Grade Gliomas With BRAF V600E Mutation

Pediatric Blood &Cancer, EarlyView.
ABSTRACT We present two pediatric cases of pediatric low‐grade gliomas (PLGG) with BRAF V600E mutations diagnosed and monitored using cerebrospinal fluid (CSF) liquid biopsy analyzed via digital droplet PCR (ddPCR), without tissue biopsy. Both patients were treated with dabrafenib and trametinib and monitored through clinical assessments, magnetic ...
Hannah Sultan, Damien Faury, Alexander G. Weil, Harrison J. Westwick, Nada Jabado, Sébastien Perreault   +5 more
wiley   +1 more source

Qualitative methods of benefit / risk assessment

Безопасность и риск фармакотерапии, 2022
In this article authors describe some existing methods of benefit / risk assessment.
A. P. Pereverzev, A. N. Mironov, N. D. Bunyatyan, V. K. Lepakhin, B. K. Romanov   +4 more
doaj  

Diagnostic assessment for mathematics in a distance learning context [PDF]

, 2008
The idea of a diagnostic process to identify students likely to benefit from additional support originated from two separate investigations relating to the performance of entry-level mathematics students at the University of South Africa (UNISA).
Bohlmann, Carol A, Fletcher, Lizelle
core