Protecting emergency responders: guidance documents.

2004 ◽  
2019 ◽  
Vol 20 (10) ◽  
pp. 835-844 ◽  
Author(s):  
Francis Micheal ◽  
Mohanlal Sayana ◽  
Balamurali Musuvathi Motial

Background: The concept of evaluating bioequivalence has changed over a period of time. Currently, the Average Bioequivalence approach (ABE) is the gold standard tool for the evaluation of generics. Of late, many debates had arisen about employing ABE approach for the appraisal of all drug categories. This review aims to examine the limitations of ABE approach and the significances of Population Bioequivalence (PBE) and Individual Bioequivalence (IBE) approach, current regulatory thinking for assessing different categories of the drug, whether they are adequately assessed, and the evaluation is in the right direction. Methods: We carried out an organized search of bibliographic databases for peer-reviewed research literatures, regulatory recommendations, guidance documents using a focused review question and eligibility criteria. The standard tools were used to appraise the quality of retrieved documents and to make sure the authenticity of the data. Results: In total 73 references were used in the review, the majority of the references (guidance documents) were from the different regulatory agencies and product-specific guidance. There were 29 product-specific guidance from USFDA and EMA. The limitations of the ABE approach were discussed in detail along with the significances of Population Bioequivalence (PBE) approach and Individual Bioequivalence (IBE) approaches. Conclusion: It is apparent from the review that IBE approach is a precise method for evaluating the drugs as it answers drug interchangeability (prescribability and switchability). IBE approach is followed by PBE approach and ABE approach for the evaluation of different categories of drugs in terms of precision.


Author(s):  
James Turner ◽  
Terri Rebmann ◽  
Travis Loux ◽  
Donghua Tao ◽  
Alexander Garza

AbstractEmergency planners and first responders often access web-based information resources during disasters; however, these tools require an active Internet connection, which may be unavailable during a disaster. The National Library of Medicine (NLM) provides several free non-web-based disaster response tools. This study assessed intention to use web-based and non-web-based informational and response tools during disasters among emergency responders and librarians. Educational workshops were held in four Missouri cities in spring, 2016. The NLM tools were presented and attendees practiced using the tools during disaster scenarios. Pre- and post-intervention data about NLM tool awareness and intention to use these tools versus other web-based resources was collected. McNemar tests assessed a pre/post change in intention to use each resource. Four workshops were held, with a total of 74 attendees. Intention to use the NLM tools was low prior to the workshops (range: 20.3–39.2%), but increased significantly immediately afterwards (p < .001 for all pre/post comparisons). The workshops resulted in increased NLM tool awareness and increased intention to use the tools during future disasters. This provides evidence of attendees’ perceptions of the usefulness of the non-web-based NLM tools in place of other web-based tools in situations without Internet access.


2020 ◽  
Vol 5 (Suppl 1) ◽  
pp. e002060
Author(s):  
Samira Aboubaker ◽  
Egmond Samir Evers ◽  
Loulou Kobeissi ◽  
Lauren Francis ◽  
Robinah Najjemba ◽  
...  

BackgroundSignificant global gains in sexual, reproductive, maternal, newborn, child and adolescent health and nutrition (SRMNCAH&N) will be difficult unless conflict settings are adequately addressed. We aimed to determine the amount, scope and quality of publically available guidance documents, to characterise the process by which agencies develop their guidance and to identify gaps in guidance on SRMNCAH&N promotion in conflicts.MethodsWe identified guidance documents published between 2008 and 2018 through English-language Internet sites of humanitarian response organisations, reviewed them for their scope and assessed their quality with the AGREE II (Appraisal of Guidelines for REsearch and Evaluation II) tool. Additionally, we interviewed 22 key informants on guidance development, dissemination processes, perceived guidance gaps and applicability.FindingsWe identified 105 conflict-relevant guidance documents from 75 organisations. Of these, nine were specific to conflicts, others were applicable also to other humanitarian settings. Fifteen documents were technical normative guidelines, others were operational guides (67), descriptive documents (21) or advice on legal, human rights or ethics questions (2). Nutrition was the most addressed health topic, followed by communicable diseases and violence. The documents rated high quality in their ‘scope and purpose’ and ‘clarity of presentation’ and low for ‘rigour of development’ and ‘editorial independence’. Key informants reported end user need as the primary driver for guideline development and WHO technical guidelines as their main evidence base. Insufficient local contextualisation, lack of inter-agency coordination and lack of systematic implementation were considered problems in guideline development. Several guidance gaps were noted, including abortion care, newborn care, early child development, mental health, adolescent health beyond sexual and reproductive health and non-communicable diseases.InterpretationOrganisations are motivated and actively producing guidance for SRMNCAH&N promotion in humanitarian settings, but few documents address conflicts specifically and there are important guidance gaps. Improved inter-organisation collaboration for guidance on SRMNCAH&N promotion in conflicts and other humanitarian settings is needed.


2021 ◽  
Vol 13 (9) ◽  
pp. 5107
Author(s):  
Cristina S. Polo López ◽  
Floriana Troia ◽  
Francesco Nocera

This paper proposes to identify an approach methodology for the incorporation of building-integrated photovoltaic systems (BIPV) in existing architectural heritage, considering regulatory, conservation and energy aspects. The main objective is to provide information about guidance criteria related to the integration of BIPV in historical buildings and about intervention methods. That will be followed by the development of useful data to reorient and update the guidelines and guidance documents, both for the design approach and for the evaluation of potential future interventions. The research methodology includes a categorization and analysis of European and Swiss case studies, taking into account the state of preservation of the building before the intervention, the data of the applied photovoltaic technology and the aesthetic and energy contribution of the intervention. The result, in the form of graphic schedules, provides complete information for a real evaluation of the analyzed case studies and of the BIPV technological system used in historical contexts. This research promotes a conscious BIPV as a real opportunity to use technology and a contemporary architectural language capable of dialoguing with pre-existing buildings to significantly improve energy efficiency and determine a new value system for the historical building and its environment.


Author(s):  
Rieke Hansen ◽  
Martina van Lierop ◽  
Werner Rolf ◽  
Damjana Gantar ◽  
Ina Šuklje Erjavec ◽  
...  

AbstractConcepts such as green infrastructure, nature-based solutions, and ecosystem services gained popularity in recent discourses on urban planning. Despite their recognition as innovative concepts, all of them share a degree of ambiguity. Fuzziness can be a weakness but also an opportunity to shape novel concepts together with the stakeholders that are supposed to implement them in the planning practice. The paper traces concept development processes of green infrastructure through transdisciplinary knowledge exchange in three different projects, a European and a national research project and a local city-regional project as part of an EU regional cooperation project. In all projects, the green infrastructure concept evolved in different stages. Stakeholder involvement during these stages span from consultation to co-creation. The cases reveal two different approaches: concepts that are developed “for planning practice” might be based on a plethora of insight via consultation, while those “with planning practice” foster co-creation and might result in high acceptance among the involved stakeholders. Depending on the purpose of the novel concept, each approach can be beneficial and result in practice-related and operational products, such as guidance documents or planning strategies. However, the cases also show that in any new context an exchange about fuzzy concepts is not only needed but also a chance to stimulate cooperation and joint understanding about urban challenges and how to address them.


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