Results 51 to 60 of about 7,752,988 (327)

To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016

BMJ Open, 2019
Objective To compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both agencies in the time period 2014–2016.Design Using publicly available information from FDA and ...
Thomas Christian Kühler, Magda Bujar, Neil McAuslane, Lawrence Liberti   +3 more
doaj   +1 more source

Eliciting trade-offs between water charges and service benefits in Scotland. ESRI Working Paper No. 655 March 2020 [PDF]

, 2020
If it is the responsibility of a regulatory body to decide where to prioritise future investment, then it is important to understand the priorities of the citizenry it represents. This paper, in collaboration with the OECD and the Scottish water industry,
Belton, Cameron A., Lavina, Ciarán, Lunna, Peter D.   +2 more
core  

A structured approach for the engineering of biochemical network models, illustrated for signalling pathways [PDF]

, 2008
http://dx.doi.org/10.1093/bib/bbn026Quantitative models of biochemical networks (signal transduction cascades, metabolic pathways, gene regulatory circuits) are a central component of modern systems biology.
Alves, Breitling, Brown, D. Gilbert, Fisher, Huang, Hucka, Kholodenko, Kholodenko, Kolch, Levchenko, M. Heiner, Mendes, Orton, R. Breitling, R. Orton, Schoeberl, Wiley   +17 more
core   +4 more sources

Safety assessment of membrane-associated protoporphyrinogen IX oxidase from Enterobacter cloacae expressed in genetically modified crops

GM Crops & Food
Crops tolerant to protoporphyrinogen IX oxidase (PPO)-inhibiting herbicides were developed by expressing an herbicide insensitive PPO, a membrane-associated protein from Enterobacter cloacae. E.
Cunxi Wang, Wenze Li, Matias S. Attene-Ramos, Colton Kessenich, Jennifer Calcaterra, Rong Wang, Bosong Xiang, Sergio Couoh-Cardel, Kimberly Hodge-Bell, Scott A. Saracco   +9 more
doaj   +1 more source

Characterization of the spectrum of insecticidal activity of Cry1B.3, Cry1Da_7, and Vip3Cb1 proteins produced by lepidopteran-protected MON 89151 cotton

Scientific Reports
The spectrum of insecticidal activity of the Cry1B.3, Cry1Da_7, and Vip3Cb1 proteins targeting lepidopteran insect pests produced by MON 89151 cotton was characterized with microbially-produced protein-incorporated diet bioassays against selected insect ...
Carlos J. Esquivel, Frankie Stubbins, Harit K. Bal, Jianguo Tan, Brent Werner, Steven Michael Reyna, Jennifer Fridley, Geoffrey Mueller, Yu Liu-Gontarek, Bingyao Li, Chen Meng, Christopher R. Brown, Tianbo Xu, Steven L. Levine, Yong Yin, Chitvan Khajuria   +15 more
doaj   +1 more source

Harmonizing health: a global analysis of pharmaceutical regulatory activities by international regulatory organizations

Frontiers in Medicine
IntroductionThis study demonstrates the role of six international organizations ICH, WHO, PIC/S, IPRP, ICMRA and IMDRF in shaping global health policies and advancing pharmaceutical progress.
Agnes Dangy-Caye, Alice Mousset, Adem Kermad, Louise Bouché-Bazerolle, Magda Bujar, Maria-Lucia De Lucia, Neil McAuslane, Rebecca Lumsden, Rebecca Lumsden   +8 more
doaj   +1 more source

Smart EV Charging: A Global Review of Promising Practices

World Electric Vehicle Journal, 2019
The electrification of transport in Europe is in the early stages of a market transformation that has the potential to significantly cut emissions in both the transportation and energy sectors, while generating wider benefits for society.
Julia Hildermeier, Christos Kolokathis, Jan Rosenow, Michael Hogan, Catharina Wiese, Andreas Jahn   +5 more
doaj   +1 more source

Clinical Insights Into Hypercalcemia of Malignancy in Childhood

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Hypercalcemia of malignancy (HCM) is a rare but life‐threatening metabolic emergency in children that occurs in less than 1% of pediatric cancer cases, with a reported incidence ranging from 0.4% to 1.0% across different studies. While it is observed in 10%–20% of adult malignancies, pediatric HCM remains relatively uncommon.
Hüseyin Anıl Korkmaz
wiley   +1 more source

Risk assessment of homologous variants of biotech trait proteins using a bridging approach

GM Crops & Food
A transgenic protein is frequently expressed as different homologous variants in genetically modified crops due to differential processing of targeting peptides or optimization of activity and specificity.
Cunxi Wang, Jennifer Calcaterra, Beverly Anderson, Timothy Rydel, Rong Wang, Lieselot Bertho, Scott A. Saracco, Kimberly Hodge-Bell, Luis Burzio, Tommi White, Bin Li   +10 more
doaj   +1 more source

Procedural Choices in Regulatory Science [PDF]

, 1993
This paper compares four approaches to using science in regulatory decision making - one very similar to the Science Court proposal. Professor Jasanoff argues generally that that proposal would be less useful than procedures more sensitive to the ...
Jasanoff, Sheila
core   +2 more sources