Results 31 to 40 of about 2,472,934 (283)

Evaluating integration in collaborative cross-disciplinary FDA new drug reviews using an input-process-output model

Journal of Clinical and Translational Science, 2021
Background/Objectives: The US Food and Drug Administration (FDA) is responsible for assessing safety (risks) and effectiveness (benefits) of new drug products using the data provided in a Sponsor’s new drug product marketing application before they can ...
Kevin Bugin, Gaetano R. Lotrecchiano, Michael O’Rourke, Joan Butler   +3 more
doaj   +1 more source

Retrospective on U.S. Health Risk Assessment: How Others Can Benefit [PDF]

, 1995
Dr. Paustenbach reviews the scientific underpinnings of about twenty years of health risk assessment practice and their implications for environmental policy.
Paustenbach, Dennis J.
core   +1 more source

Psychosocial Outcomes in Patients With Endocrine Tumor Syndromes: A Systematic Review

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Introduction The combination of disease manifestations, the familial burden, and varying penetrance of endocrine tumor syndromes (ETSs) is unique. This review aimed to portray and summarize available data on psychosocial outcomes in patients with ETSs and explore gaps and opportunities for future research and care.
Daniël Zwerus, Floortje Strobbe, Annemarie A. Verrijn Stuart, Hanneke M. van Santen, Gerlof D. Valk, Sasja A. Schepers, Rachel S. van Leeuwaarde   +6 more
wiley   +1 more source

How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action

Frontiers in Pharmacology, 2023
Objective: Patients have unique insights and are (in-)directly affected by each decision taken throughout the life cycle of medicinal products. Patient preference studies (PPS) assess what matters most to patients, how much, and what trade-offs patients ...
Rosanne Janssens, Liese Barbier, Mireille Muller, Irina Cleemput, Isabelle Stoeckert, Chiara Whichello, Bennett Levitan, Tarek A. Hammad, Charis Girvalaki, Juan-Jose Ventura, Karin Schölin Bywall, Karin Schölin Bywall, Cathy Anne Pinto, Elise Schoefs, Eva G. Katz, Ulrik Kihlbom, Isabelle Huys   +16 more
doaj   +1 more source

Nutritional and Behavioral Intervention for Long‐Term Childhood Acute Leukemia Survivors With Metabolic Syndrome

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Purpose Metabolic syndrome (MetS) is a common complication in survivors of childhood acute lymphoblastic and myeloid leukemia (AL), and a major risk factor for premature cardiovascular disease, type‐2‐diabetes, and metabolic dysfunction‐associated steatotic liver disease (MASLD).
Visentin Sandrine, Béliard Sophie, Renard Cécile, Caussy Cyrielle, Hamidou Zeinab, Romano David, Gacem Mélanie, Petit Arnaud, Saultier Paul, Borentain Patrick, Michel Gérard   +10 more
wiley   +1 more source

Fetal exposure to perfluoroalkyl substances (PFAS) in drinking water and congenital malformations: A nation-wide register-based study on PFAS in drinking water

Environment International
Background: Teratogenic properties of perfluoroalkyl substances (PFAS) have been assessed in a few studies, however, epidemiological evidence for an association is inconclusive.
Melle Säve-Söderbergh, Irina Gyllenhammar, Tessa Schillemans, Emelie Lindfeldt, Carolina Vogs, Carolina Donat-Vargas, Emma Halldin Ankarberg, Anders Glynn, Lutz Ahrens, Emilie Helte, Agneta Åkesson   +10 more
doaj   +1 more source

Survival for Children Diagnosed With Wilms Tumour (2012–2022) Registered in the UK and Ireland Improving Population Outcomes for Renal Tumours of Childhood (IMPORT) Study

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background The Improving Population Outcomes for Renal Tumours of childhood (IMPORT) is a prospective clinical observational study capturing detailed demographic and outcome data on children and young people diagnosed with renal tumours in the United Kingdom and the Republic of Ireland.
Naomi Ssenyonga, Angela Lopez‐Cortes, Reem Al‐Saadi, Suzanne Tugnait, Kristina Dzhuma, Catriona Duncan, Gordan Vujanic, Tanzina Chowdhury, Claudia Allemani, Michel P. Coleman, Kathy Pritchard‐Jones, the Children's Cancer and Leukaemia Group (CCLG) Renal Tumour Special Interest Group, Hugh Bishop, Anthony McCarthy, Pamela Kearns, Helen Rees, Amos Burke, Meriel Jenney, Jane Pears, Hamish Wallace, Milind Ronghe, Tanzina Chowdhury, Susan Picton, Emma Ross, Lisa Howell, Bernadette Brennan, Gail Halliday, Richard Grundy, Shaun Wilson, Sucheta Vaidya, Daniel Yeomanson, Jessica Bate, Vesna Pavasovic, Jessica Bate, Sabine Irtan, Jesper Brok, Minou Oostveen, Kristina Dzhuma, Mark Weeks, Richard Williams, Mark Powis, Max Pachl, Bruce Okoye, Naima Smeulders, Gordan Vujanic, Oystein Olsen, Tom Watson, Susan Shelmerdine, Dan Saunders, Angela Lopez-Cortes, Taryn Treger, Tom Jackson, Suzanne Tugnait, Lisa Howell, Tanzina Chowdhury, Sam Behjati, Angela Polanco   +56 more
wiley   +1 more source

Fostering unsustainability? An analysis of 4-year-olds' dietary impacts in Sweden

Current Research in Environmental Sustainability
The dietary impacts of 746 young Swedish children were assessed across ten indicators: carbon footprint, cropland use, new nitrogen and phosphorus inputs, blue water use, ammonia emissions, pesticide use, biodiversity loss, antibiotic use, and animal ...
Maria Jacobsen, Lotta Moraeus, Emma Patterson, Anna Karin Lindroos, Mattias Eriksson, Elin Röös   +5 more
doaj   +1 more source

Please get me out of here: The difficult decision making in fit-to-fly assessments for international fixed-wing air ambulance operations

Travel Medicine and Infectious Disease, 2023
Introduction: With international travel for leisure and business almost back to pre-pandemic levels, demand for repatriation due to illness and injury abroad is increasing [1,2].
Alex Veldman, Michael Diefenbach, Laurent Taymans, Bettina Vadera, Joseph Lelo, Yann Rouaud   +5 more
doaj   +1 more source

Truth disclosure on prognosis: Is it ethical not to communicate personalised risk of death? [PDF]

, 2018
Predicting risk of death based on personalised and objective clinical indicators is an improvement over intuition and clinical judgement. Risk assessment can benefit clinicians by improving prognostic certainty, and truth disclosure helps patients and ...
Brabrand, Mikkel, Cardona, Magnolia, Kellett, John, Lewis, Ebony, Ní Chróinín, Danielle   +4 more
core   +1 more source