Results 1 to 10 of about 578,139 (333)

Molecular assays for antimalarial drug resistance surveillance: A target product profile. [PDF]

PLoS ONE, 2018
Antimalarial drug resistance is a major constraint for malaria control and elimination efforts. Artemisinin-based combination therapy is now the mainstay for malaria treatment.
Christian Nsanzabana, Frederic Ariey, Hans-Peter Beck, Xavier C Ding, Edwin Kamau, Sanjeev Krishna, Eric Legrand, Naomi Lucchi, Olivo Miotto, Sidsel Nag, Harald Noedl, Cally Roper, Philip J Rosenthal, Henk D F H Schallig, Steve M Taylor, Sarah K Volkman, Iveth J Gonzalez   +16 more
doaj   +3 more sources

Decision support environment for medical product safety surveillance

Journal of Biomedical Informatics, 2016
We have developed a Decision Support Environment (DSE) for medical experts at the US Food and Drug Administration (FDA). The DSE contains two integrated systems: The Event-based Text-mining of Health Electronic Records (ETHER) and the Pattern-based and Advanced Network Analyzer for Clinical Evaluation and Assessment (PANACEA).
Taxiarchis, Botsis, Christopher, Jankosky, Deepa, Arya, Kory, Kreimeyer, Matthew, Foster, Abhishek, Pandey, Wei, Wang, Guangfan, Zhang, Richard, Forshee, Ravi, Goud, David, Menschik, Mark, Walderhaug, Emily Jane, Woo, John, Scott   +13 more
openaire   +4 more sources

Target Product Profile for Salmonella Environmental Surveillance 

, 2023
This Target Product Profile is meant to spur development of a product or set of products that fulfill the needs for typhoid surveillance using environmental samples. It was developed by BMGF in consultation with experts in the fields of epidemiology, environmental surveillance, and microbiology.
Bill Melinda Gates Foundation
openaire   +2 more sources

Discrepancies in regulations in post-marketing safety surveillance of drug-device combination products in the EU and US: a review. [PDF]

Front Drug Saf Regul
D'souza J, Nandave M, Blöchlinger R.
europepmc   +3 more sources

Real-World Use of Generic Meropenem: Results of an Observational Study

Antibiotics, 2021
Background: To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response.
Santiago Garnica-Velandia, Luz Adriana Aristizábal-Ruiz, Carlos Arturo Alvarez-Moreno   +2 more
doaj   +1 more source

Analysis of Relationship between Levofloxacin and Corrected QT Prolongation Using a Clinical Data Warehouse [PDF]

Healthcare Informatics Research, 2011
ObjectiveThe aim of this study was to examine whether or not levofloxacin has any relationship with QT prolongation in a real clinical setting by analyzing a clinical data warehouse of data collected from different hospital information systems ...
Man Young Park, Eun Yeob Kim, Young Ho Lee, Woojae Kim, Ku Sang Kim, Seung Soo Sheen, Hong Seok Lim, Rae Woong Park   +7 more
doaj   +1 more source

Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26–52, including a treatment switch from reference ADL to PF-06410293

RMD Open, 2021
Objective To investigate the efficacy, safety, immunogenicity and pharmacokinetics of biosimilar adalimumab (ADL) PF-06410293 (ADL-PF; adalimumab-afzb) versus EU-sourced reference ADL (ADL-EU) in patients with active rheumatoid arthritis (RA) on longer ...
Rieke Alten, Carol Cronenberger, Daniel F Alvarez, Amy E Bock, Ivana Vranic, Wuyan Zhang   +5 more
doaj   +1 more source

Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework

Frontiers in Reproductive Health, 2023
Urinary incontinence (UI) or involuntary loss of urine is a common chronic medical condition among women. It is estimated that 5%−70% of the population experiences incontinence with most studies suggesting 25%−45% of the population.
Edburga L. Krause, Anne M. Hattersley, Joan M. Abbinante-Nissen, Denise Gutshall, Kara E. Woeller   +4 more
doaj   +1 more source

Influence of SARS-CoV-2 surveillance outputs produced by the UK health security agency (UKHSA) outbreak surveillance team on decision-making by local stakeholders

BMC Public Health, 2023
Background The UK Health Security Agency (UKHSA) COVID-19 Outbreak Surveillance Team (OST) was established in June 2020 to provide Local Authorities (LAs) in England with surveillance intelligence to aid their response to the SARS-CoV-2 epidemic. Reports
Katriina Willgert, Jo Hardstaff, Stephanie Shadwell, Alex Bhattacharya, Paula Blomquist, Roberto Vivancos, Ian Simms   +6 more
doaj   +1 more source

Post-marketing surveillance for the safety of the 9-valent human papillomavirus vaccine: a retrospective real-world study in China

Expert Review of Vaccines, 2023
Background The 9-valent human papillomavirus (9vHPV) vaccine was introduced in China in 2018. This study was conducted to monitor the occurrence of new-onset autoimmune diseases (AIs) in Chinese women vaccinated with the 9vHPV vaccine and adverse ...
Ruogu Meng, Rui Ma, Jianmei Wang, Peipei Liu, Zuoxiang Liu, Bingjie He, Zhike Liu, Yu Yang, Siyan Zhan   +8 more
doaj   +1 more source