Results 31 to 40 of about 29,276,589 (300)

Pharmacists and Regulatory Science

YAKUGAKU ZASSHI, 2017
For providing appropriate pharmacotherapy, "Doing the right things, and doing things right" are necessary. Additionally, vigilance is required for the appropriate use of pharmaceuticals. Evidence-based medicine has been a common approach to healthcare, and many guidelines have been published. In addition, risk management plans (RMPs) are developed upon
openaire   +3 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

Regulatory Science Transparency: Assessment Of Environmental Protection Agency’s Proposed Rule on Strengthening Transparency in Regulatory Science

, 2019
In its proposed rule, Strengthening Transparency in Regulatory Science, the Environmental Protection Agency (EPA) requires transparency in certain areas of regulatory science.
Sohail, Saher, Sohail, Soha, Pan, Tianze, Alsharif, Mansour, Shadid, Hadeel, Moghissi, A. Alan, Ginigeme, Anita, Debrah, Henry, Calderone, Richard A., Ephraim, Natalie, Trippe, Lauren, Alessa, Yousef, Ogletree, Camden, Real, Lismary, Garrison, Destini, Lamoureux, Bralen, Li, Yanzhuo, Persaud, Misti, Jaeger, Lisa M., Lin, Yuhan, Oh, Joohye   +20 more
core   +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

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

Evidence‐Informed Multidisciplinary Consensus Guidance for the Psychosocial Care of Adolescents With High‐Risk Cancer: Recommendations From the Italian Association of Pediatric Hematology and Oncology

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Adolescents with high‐risk cancer face complex developmental, psychosocial, and ethical challenges that extend beyond disease‐directed treatment. Although international recommendations exist for communication, psychosocial care, pediatric palliative care, survivorship, and shared decision‐making, these have largely evolved within ...
Johanna M. C. Blom, Dorella Scarponi, Giulia Zucchetti, Teresa Perillo, Maria Montanaro, Elisa Marconi, Chiara Rutigliano, Paolo Colavero, Paola Quarello, Marina Bertolotti, Monica Cellini, Carlo Clerici, Maurizio Mascarin, Francesca Bomben, Andrea Ferrari, the expert workgroup   +15 more
wiley   +1 more source

Communicating to and engaging with the public in regulatory science[Link] [PDF]

EFSA Journal, 2019
This paper presents selected highlights from the 'Engaging with society' session of EFSA's third Scientific Conference 'Science, Food and Society' (Parma, Italy, 18-21 September 2018). The social dimension for scientific advisory bodies largely concerns science communication and public engagement.
Smith, Anthony, Parrino, Lucia, Vrbos, Domagoj, Nicolini, Giulia, Bucchi, Massimiano, Carr, Melanie, Chen, Junshi, Dendler, Leonie, Krishnaswamy, Kannan, Lecchini, Davide, Löfstedt, Ragnar, Patel, Michelle, Reisch, Lucia, Verloo, Didier, Vos, Ellen, Zollo, Fabiana, Gallani, Barbara   +16 more
openaire   +5 more sources

Standardization and the Role of Regulatory Science

, 2014
Advancing the science of creating tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products, a working definition for Regulatory Science by the Food and Drug Administration (FDA), aligns closely ...
Herrman, Tim
core   +1 more source

Regulatory Sciences

Pharmacy Education, 2020
Accepted abstracts under the theme: REGULATORY SCIENCES (n=10)
openaire   +2 more sources