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guidance on the renewal of the authorisation of feed additives

EFSA JOURNAL 2021年第1期19卷 e06340页

作者： Bampidis, Vasileios Azimonti, Giovanna Bastos, Maria de Lourdes Christensen, Henrik Dusemund, Birgit Durjava, Mojca Fasmon Kouba, Maryline Lopez-Alonso, Marta Puente, Secundino Lopez Marcon, Francesca Mayo, Baltasar Pechova, Alena Petkova, Mariana Ramos, Fernando Sanz, Yolanda Villa, Roberto Edoardo Woutersen, Ruud Anguita, Montserrat Galobart, Jaume Guajardo, Irene Munoz Innocenti, Matteo Lorenzo EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the renewal of the authorisation of additives for use in animal nutrition. (c) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

关键词： guidance renewal feed additives characterisation safety efficacy

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Lexicon for guidance terminology in pediatric hematology/oncology: A White Paper

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PEDIATRIC BLOOD & CANCER 2020年第4期67卷 e28170-e28170页

作者： Dupuis, L. Lee Robinson, Paula D. van de Wetering, Marianne D. Tissing, Wim Seelisch, Jennifer Digout, Carol Sung, Lillian Phillips, Robert Bajwa, Rajinder Bauters, Tiene Groll, Andreas H. Gunter, Danielle Howard, Scott Kremer, Leontien Loeffen, Erik A. H. Orsey, Andrea Portwine, Carol Univ Toronto Hosp Sick Children Leslie Dan Fac Pharm Res Inst Toronto ON Canada Univ Toronto Hosp Sick Children Leslie Dan Fac Pharm Dept Pharm Toronto ON Canada Pediat Oncol Grp Ontario Toronto ON Canada Princess Maxima Ctr Pediat Oncol Utrecht Netherlands Univ Groningen Univ Med Ctr Groningen Dept Pediat Oncol Groningen Netherlands Western Univ Childrens Hosp London Hlth Sci Ctr Div Hematol Oncol London ON Canada Atlantic Provinces Hematol Oncol Network Halifax NS Canada Hosp Sick Children Res Inst 555 Univ Ave Toronto ON M5G 1X8 Canada Hosp Sick Children Dept Paediat Div Haematol Oncol Toronto ON Canada Leeds Teaching Hosp NHS Trust Leeds Childrens Hosp Leeds W Yorkshire England Univ York Ctr Reviews & Disseminat York N Yorkshire England

Terms used to label types of clinical recommendations and guidance are applied inconsistently and do not reflect the methods used to create each type. Here, the international Pediatric Oncology Supportive Care Guideline Network proposes a lexicon for types of recommendations and guidance documents. A lexicon describing three types of recommendations (clinical practice guideline-derived, good practice statement, and expert opinion statement) and two types of guidance documents (clinical practice guideline and expert opinion) is presented. Consistent use of this lexicon will allow pediatric oncology clinicians to readily appreciate the methods used to create clinical guidance.

关键词： clinical practice guideline guidance recommendation

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Resumption of laser/IPL skin services post COVID-19 lockdown-British Medical Laser Association (BMLA) guidance document

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LASERS IN MEDICAL SCIENCE 2020年第9期35卷 2069-2073页

作者： Madan, Vishal Salford Royal NHS Fdn Trust Stott Lane Salford M6 8HD Lancs England British Med Laser Assoc Manchester Lancs England

The COVID-19 pandemic has had a significant negative impact on the global health economies. As health care resources have been prioritised to cater for patients affected by COVID-19, routine health care services have remained suspended. In an effort to slow the spread of SARS-CoV-2 virus, the UK introduced a country-wide lockdown which came into effect on the 23rd March 2020. Since then, clinics offering laser and intense pulsed light services have remained closed for business. As the rate of COVID-19 infection slows, the UK government has issued guidance for lifting of the lockdown in a cautious and phased manner. With this in view and to facilitate safe resumption of laser and intense pulsed light services, the British Medical Laser Services has issued this guidance document, based on best available and current scientific evidence.

关键词： Aerosol Coronavirus COVID 19 guidance Laser Pandemic Plume SARS-CoV-2 virus

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Invasive species watch lists: guidance for development, communication, and application

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BIOLOGICAL INVASIONS 2020年第1期22卷 47-51页

作者： Reaser, Jamie K. Frey, Mark Meyers, N. Marshall Ctr Large Landscape Conservat 303 W Mendenhall St 4 Bozeman MT 59715 USA Natl Pk Serv 100 Alabama St SW Atlanta GA 30306 USA PLLC 1620 L St NWSte 610 Washington DC 20036 USA

A watch list is a list of invasive species to be prioritized for surveillance, reporting, and other possible responses in order to reduce the risk of impact to valued assets. Watch lists are basic, yet multi-functional tools for the early detection of and rapid response to invasive species. There is, however, a need to substantially improve watch list standardization, accessibility, and associated communication strategies. We provide guidance to achieve these aims, including an overview of guiding principles and a list of questions to consider when one develops, communicates, and applies invasive species watch lists. Our guidance is intended to support invasive species watch lists development and application globally.

关键词： Invasive species Watch list Detection Survey Early detection and rapid response (EDRR) guidance

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guidance on the preparation and submission of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 (Revision 1)

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EFSA JOURNAL 2021年第3期19卷 e06557页

作者： Turck, Dominique Bresson, Jean-Louis Burlingame, Barbara Dean, Tara Fairweather-Tait, Susan Heinonen, Marina Hirsch-Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J. Naska, Androniki Neuhaeuser-Berthold, Monika Nowicka, Grazyna Pentieva, Kristina Sanz, Yolanda Siani, Alfonso Sjoedin, Anders Stern, Martin Tome, Daniel Vinceti, Marco Willatts, Peter Engel, Karl-Heinz Marchelli, Rosangela Poeting, Annette Poulsen, Morten Schlatter, Josef Gelbmann, Wolfgang de Sesmaisons-Lecarre, Agnes Verhagen, Hans van Loveren, Hendrik EFSA Panel on Dietetic Products Nutrition and Allergies (NDA)

Following the adoption of Regulation (EU) 2015/2283 on Novel Foods, the European Commission requested EFSA to develop a scientific and technical guidance for the preparation and submission of notifications for traditional foods from third countries. This guidance presents a common format for the organisation of the information to be presented by applicant for the preparation of a well-structured dossier. The safety of a traditional food should be substantiated by reliable data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. This guidance is also intended to support applicants in providing the type and quality of information EU Member States and EFSA need for the assessments of traditional foods from third countries. The applicant should integrate the information on the composition and the experience of continued use and provide a concise overall consideration on how this substantiates the history of safe use of the traditional food and how this relates to the proposed conditions of use for the EU. Where potential health hazards have been identified on the basis of the composition and/or data from the experience of continued use, they should be discussed. On the basis of the information provided, EFSA will assess the safety related to the consumption of the traditional food under the proposed conditions of use. This guidance was originally adopted by the NDA Panel in 2016. It has been revised in 2020 to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. It is applicable to all notifications and applications submitted as of 27 March 2021. The 2016 version remains applicable to notifications and applications submitted before 27 March 2021. (C) 2021 European Food Safety Authority. EFSA Journal published by John

关键词： guidance novel foods traditional foods third country primary production safety

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COVID-19 of dialysis patients in Japan: Current status and guidance on preventive measures

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THERAPEUTIC APHERESIS AND DIALYSIS 2020年第4期24卷 361-365页

作者： Kikuchi, Kan Nangaku, Masaomi Ryuzaki, Munekazu Yamakawa, Tomoyuki Hanafusa, Norio Sakai, Ken Kanno, Yoshihiko Ando, Ryoichi Shinoda, Toshio Nakamoto, Hidetomo Akizawa, Tadao Shimoochiai Clin Div Nephrol Tokyo Japan Univ Tokyo Div Nephrol & Endocrinol Grad Sch Med Tokyo Japan Tokyo Saiseikai Cent Hosp Dept Nephrol Tokyo Japan Shirasagi Hosp Kidney Ctr Osaka Japan Tokyo Womens Med Univ Dept Blood Purificat Tokyo Japan Toho Univ Dept Nephrol Fac Med Tokyo Japan Tokyo Med Univ Dept Nephrol Tokyo Japan Seishokai Mem Hosp Dept Nephrol Tokyo Japan Tsukuba Int Univ Fac Med & Hlth Sci Tsuchiura Ibaraki Japan Saitama Med Univ Dept Gen Internal Med Saitama Japan Showa Univ Dept Med Div Nephrol Sch Med Tokyo Japan

In Japan, the first case of COVID-19 in dialysis patients was reported on March 1, 2020. A total of 31 cases were reported by April 10, and it increased to 95 by May 15. Thereafter, with the rapid increase in the number of COVID-19 cases in the general population since late March, there was a not surprising increase in the number of COVID-19 cases in dialysis patients. The mortality rate is 16.2% (16/99 cases) in dialysis patients, which is higher than 5.3% (874/16 532 cases) in the general population. This higher mortality rate in dialysis patients with COVID-19 might be related to their age;the majority of COVID-19 cases are aged between 70 and 90 years old in dialysis patients, compared with between 20 and 60 years old in the general population. As COVID-19 presents with severe symptoms and is associated with a high mortality rate in dialysis patients, dialysis patients who have contracted severe acute respiratory syndrome coronavirus 2 infection confirmed by polymerase chain reaction testing are required to be hospitalized under Japanese government policy. In cases of COVID-19 hospitalizations, it is essential to prevent nosocomial infection. Therefore, patients must be sufficiently instructed in infection prevention and robust measures to prevent contraction and spread of the infection must be taken at dialysis facilities.

关键词： COVID-19 dialysis guidance infection control severe acute respiratory syndrome coronavirus 2 infection

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guidance command generation and nonlinear dynamic inversion control for reusable launch vehicles

Guidance command generation and nonlinear dynamic inversion ...

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69th International Astronautical Congress (IAC)

作者： Acquatella, Paul B. Briese, Lale Evrim Schnepper, Klaus German Aerosp Ctr DLR Inst Syst Dynam & Control D-82234 Oberpfaffenhofen Germany

Future launch vehicle concepts and technologies for expendable and reusable launch vehicles are currently investigated by the DLR research projects AKIRA and X-TRAS. In particular, the winged Liquid Fly-back Booster concept LFBB based on an LOX/LH2 propellant combination for vertical takeoff and vertical landing (VTVL), as well as the delta-winged horizontal takeoff and horizontal landing (HTHL) concept AURORA based on an LOX/Kerosene propellant combination are considered in these projects. Because of the complexity and risks involved in on-line trajectory optimization, off-line reference trajectories are still considered important for tracking purposes. In that sense, the goal of this paper is to investigate an off-line and general-purpose guidance and control (G&C) architecture for preliminary studies of reusable launch vehicles. This is done by using trajectory optimization combined with MODELICA models for the generation of optimal guidance commands, and then trajectory tracking is performed by means of inner-loop feedback controls in terms of nonlinear dynamic inversion with prescribed desired dynamics. We showcase the advantages of this baseline G&C architecture in terms of early stability and controllability aspects during the preliminary design studies of an example configuration of a reusable launch vehicle investigated in the context of the research projects above mentioned.

关键词： Trajectory optimization guidance Nonlinear control Dynamic inversion Reusable space launchers

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In-hospital management of persons with haemophilia and COVID-19: Practical guidance

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HAEMOPHILIA 2020年第5期26卷 768-772页

作者： Hermans, Cedric Lambert, Catherine Sogorb, Amaury Wittebole, Xavier Belkhir, Leila Yombi, Jean Cyr Catholic Univ Louvain Clin Univ St Luc Div Haematol Haemostasis & Thrombosis Unit Brussels Belgium Catholic Univ Louvain Clin Univ St Luc Div Intens Care Brussels Belgium Catholic Univ Louvain Clin Univ St Luc Dept Internal Med Div Infect Dis Brussels Belgium

A new disease (COVID-19) caused by a coronavirus (SARS-CoV-2) that appeared in China at the end of 2019 is currently spreading globally. This emerging virus is mainly responsible for respiratory tract infections and potentially fatal pneumonia, mainly in more frail patients. Persons with haemophilia of variable severity and from all parts of the world will likely be infected and develop COVID-19. We here propose practical guidance for the in-hospital specific management of haemophilia persons with COVID-19 including their possible transfer to the intensive care unit. Rapid identification of the haemophilia status, undelayed and regular liaison with the haemophilia team, proper therapy with factor concentrates or alternative treatments appear instrumental to prevent haemophilia-related complications in this setting. Information of patients and their families about COVID-19, psychological support and good appreciation of the impact of haemophilia on therapeutic decisions including end-of-life directives are also addressed.

关键词： COVID-19 guidance haemophilia SARS-CoV-2

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Comparison of Ultrasound and Electrical Stimulation guidance for Botulinum Neurotoxin Injections: A Randomized Cross-Over Study

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TOXICON 2022年第Sup1期214卷 S49-S49页

作者： Simpson, David Nmashie, Alexandra George, Mary Catherine Shin, Susan Karp, Barbara Tse, Winona Frucht, Steven Wu, Tianxia Koo, Vivian Alter, Katharine Considine, Elaine Norato, G. Hallett, Mark Lungu, Codrin Icahn Sch Med Mt Sinai New York NY 10029 USA NYU Sch Med New York NY USA NINDS Clin Trials Unit NIH Bethesda MD USA

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guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1)

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EFSA JOURNAL 2021年第3期19卷 e06555页

作者： Turck, Dominique Bresson, Jean-Louis Burlingame, Barbara Dean, Tara Fairweather-Tait, Susan Heinonen, Marina Hirsch-Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J. Naska, Androniki Neuhauser-Berthold, Monika Nowicka, Grazyna Pentieva, Kristina Sanz, Yolanda Siani, Alfonso Sjodin, Anders Stern, Martin Tome, Daniel Vinceti, Marco Willatts, Peter Engel, Karl-Heinz Marchelli, Rosangela Poting, Annette Poulsen, Morten Salminen, Seppo Schlatter, Josef Arcella, Davide Gelbmann, Wolfgang de Sesmaisons-Lecarre, Agnes Verhagen, Hans van Loveren, Hendrik

Following the adoption of Regulation (EU) 2015/2283 on novel foods, the European Commission requested EFSA develop scientific and technical guidance for the preparation and submission of applications for authorisation of novel foods. This guidance presents a common format for the organisation of the information to be presented by the applicant when preparing a well-structured application to demonstrate the safety of the novel food. It outlines the data needed for the safety assessments of novel foods. Requirements relate to the description of the novel food, production process, compositional data, specification, proposed uses and use levels, and anticipated intake of the novel food. Further sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity should be considered by the applicant by default. If not covered in the application, this should be justified. The applicant should integrate the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they should be discussed in relation to the anticipated intakes of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use. This guidance was originally adopted in 2016. It has been revised to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. This revised guidance applies to all dossiers submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021. (C) 2021 European Food Safety Author

关键词： guidance novel foods traditional foods authorisation safety toxicity

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