Handling unstable analytes: literature review and expert panel survey by Japan Bioanalysis Forum Discussion Group

Bioanalysis ◽  
2021 ◽  
Author(s):  
Makoto Niwa ◽  
Ayaka Kondo ◽  
Emi Shibutani ◽  
Atsushi Tsuruta ◽  
Eiichi Shimada ◽  
...  

Analyzing unstable small molecule drugs and metabolites in blood continues to be challenging for bioanalysis. Although scientific countermeasures such as immediate cooling, immediate freezing, addition of enzyme inhibitors, pH adjustment, dried blood spot or derivatization have been developed, selecting the best practices has become an issue in the pharmaceutical industry as the number of drugs with such problems is increasing, even for generic drugs. In this study, we conducted a comprehensive literature review and a questionnaire survey to determine a suitable practice for evaluating instability and implementing countermeasures. Three areas of focus, matrix selection, effect of hemolysis and selection of esterase inhibitors, are discussed.

2011 ◽  
Vol 4 (12) ◽  
pp. 37 ◽  
Author(s):  
Steven H. Appelbaum ◽  
Anis Samaha

The objective of this article is to study the effectiveness of the company-partner relationship when outsourcing business processes in a large aerospace company. The intent is to supplement existing anecdotal evidence with data collected through a structured methodology in an effort to highlight process inefficiencies that may lead to hidden costs. Recommendations are provided to management as a means of addressing the process gaps to improve productivity. A literature review was conducted and a selection of findings from relevant papers and studies were retained as best practices for a successful outsourcing venture. These findings were then used to generate questions as part of a survey. The latter was distributed to 90 employees and managers from both the company and the vendor with the purpose of identifying gaps with the literature. A mismatch between the survey results and the literature would signal an improvement opportunity requiring management of attention. Although the overall health of the outsourcing process is satisfactory, several aspects of the working relationship were found to be deficient and the cause of inefficiencies (i.e. loss time, frustration, increased cost ). In particular, employees from both sides found a lack in upfront planning, communication of expectations, and information sharing. Furthermore, both employees and managers expressed concern about the need for training to better deal with cultural differences and motivation.


Author(s):  
H. І. Demydas ◽  
S. P. Poltoretskyi ◽  
L. М. Burko ◽  
S. S. Veiler

In the article analytical literature review of Ukrainian and world best practices on common vetch growing in binary sowings was conducted. Scientific publications of domestic and foreign scientists on the significance of binary crops in fodder production, selection of crops for joint cultivation were analyzed. The generalization and systematization of the studied material was carried out. Purpose of the research was to conduct an analytical literature review of Ukrainian and world best practices on common vetch growing in binary crops. General scientific methods, in particular, the following: hypothesis, observation, analysis, synthesis, induction and deduction, abstraction and generalization were used during the research. Own observations and literature sources from the chosen field of research were the uased in the material. Scientific publications of domestic and foreign scientists on the significancy of binary crops in fodder production, selection of crops for joint growing were analyzed to achieve this purpose. Generalization and systematization of the studied in tha research material was carried out. Conclusions. It was found that common vetch is mainly cultivated in mixtures with spring cereals. This crop can be grown for both spring and summer sowing in topping and post-harvest sowings with oats, barley, Sudan grass and other spring cereal crops; for hay and seeds — in arid conditions with a continental climate. However, seed yields in such regions are very low and vary considerably depending on the amount and distribution of spring rains. Providing of livestock production with high-quality fodders due to legume-and-cereal mixtures of annual crops makes it possible to expand the range of fodders in the diets of ruminants in the stall period.


2020 ◽  
pp. JCO.20.02510
Author(s):  
Neelima Denduluri ◽  
Mark R. Somerfield ◽  
Mariana Chavez-MacGregor ◽  
Amy H. Comander ◽  
Zoneddy Dayao ◽  
...  

PURPOSE The aim of this work is to update key recommendations of the ASCO guideline adaptation of the Cancer Care Ontario guideline on the selection of optimal adjuvant chemotherapy regimens for early breast cancer and adjuvant targeted therapy for breast cancer. METHODS An Expert Panel conducted a targeted systematic literature review guided by a signals approach to identify new, potentially practice-changing data that might translate into revised guideline recommendations. RESULTS The Expert Panel reviewed abstracts from the literature review and identified one article for inclusion that reported results of the phase III, open-label KATHERINE trial. In the KATHERINE trial, patients with stage I to III human epidermal growth factor receptor 2 (HER2)–positive breast cancer with residual invasive disease in the breast or axilla after completing neoadjuvant chemotherapy and HER2-targeted therapy were allocated to adjuvant trastuzumab emtansine (T-DM1; n = 743) or to trastuzumab (n = 743). Invasive disease–free survival was significantly higher in the T-DM1 group than in the trastuzumab arm (hazard ratio, 0.50; 95% CI, 0.39 to 0.64; P < .001), and risk of distant recurrence was lower in patients who received T-DM1 than in patients who received trastuzumab (hazard ratio, 0.60; 95% CI, 0.45 to 0.79). Grade 3 or higher adverse events occurred in 190 patients (25.7%) who received T-DM1 and in 111 patients (15.4%) who received trastuzumab. RECOMMENDATIONS Patients with HER2-positive breast cancer with pathologic invasive residual disease at surgery after standard preoperative chemotherapy and HER2-targeted therapy should be offered 14 cycles of adjuvant T-DM1, unless there is disease recurrence or unmanageable toxicity. Clinicians may offer any of the available and approved formulations of trastuzumab, including trastuzumab, trastuzumab and hyaluronidase-oysk, and available biosimilars. Additional information can be found at www.asco.org/breast-cancer-guidelines


2015 ◽  
Vol 4 (3) ◽  
Author(s):  
Eileen Ng ◽  
Pierpaolo De Colombani

Evidence-based public health has commonly relied on findings from empirical studies, or research-based evidence. However, this paper advocates that practice-based evidence derived from programmes implemented in real-life settings is likely to be a more suitable source of evidence for inspiring and guiding public health programmes. Selection of best practices from the array of implemented programmes is one way of generating such practice-based evidence. Yet the lack of consensus on the definition and criteria for practice-based evidence and best practices has limited their application in public health so far. To address the gap in literature on practice-based evidence, this paper hence proposes measures of success for public health interventions by developing an evaluation framework for selection of best practices. The proposed framework was synthesised from a systematic literature review of peer-reviewed and grey literature on existing evaluation frameworks for public health programmes as well as processes employed by health-related organisations when selecting best practices. A best practice is firstly defined as an intervention that has shown evidence of effectiveness in a particular setting and is likely to be replicable to other situations. Regardless of the area of public health, interventions should be evaluated by their context, process and outcomes. A best practice should hence meet most, if not all, of eight identified evaluation criteria: relevance, community participation, stakeholder collaboration, ethical soundness, replicability, effectiveness, efficiency and sustainability. Ultimately, a standardised framework for selection of best practices will improve the usefulness and credibility of practice-based evidence in informing evidence-based public health interventions.


2016 ◽  
Vol 04 (01) ◽  
pp. 4-10

AbstractImmunosuppression permits graft survival after transplantation and consequently a longer and better life. On the other hand, it increases the risk of infection, for instance with cytomegalovirus (CMV). However, the various available immunosuppressive therapies differ in this regard. One of the first clinical trials using de novo everolimus after kidney transplantation [1] already revealed a considerably lower incidence of CMV infection in the everolimus arms than in the mycophenolate mofetil (MMF) arm. This result was repeatedly confirmed in later studies [2–4]. Everolimus is now considered a substance with antiviral properties. This article is based on the expert meeting “Posttransplant CMV infection and the role of immunosuppression”. The expert panel called for a paradigm shift: In a CMV prevention strategy the targeted selection of the immunosuppressive therapy is also a key element. For patients with elevated risk of CMV, mTOR inhibitor-based immunosuppression is advantageous as it is associated with a significantly lower incidence of CMV events.


2018 ◽  
Author(s):  
Srijesa Khasnabish ◽  
Zoe Burns ◽  
Madeline Couch ◽  
Mary Mullin ◽  
Randall Newmark ◽  
...  

BACKGROUND Data visualization experts have identified core principles to follow when creating visual displays of data that facilitate comprehension. Such principles can be applied to creating effective reports for clinicians that display compliance with quality improvement protocols. A basic tenet of implementation science is continuous monitoring and feedback. Applying best practices for data visualization to reports for clinicians can catalyze implementation and sustainment of new protocols. OBJECTIVE To apply best practices for data visualization to create reports that clinicians find clear and useful. METHODS First, we conducted a systematic literature review to identify best practices for data visualization. We applied these findings and feedback collected via a questionnaire to improve the Fall TIPS Monthly Report (FTMR), which shows compliance with an evidence-based fall prevention program, Fall TIPS (Tailoring Interventions for Patient Safety). This questionnaire was based on the requirements for effective data display suggested by expert Stephen Few. We then evaluated usability of the FTMR using a 15-item Health Information Technology Usability Evaluation Scale (Health-ITUES). Items were rated on a 5-point Likert scale from strongly disagree (1) to strongly agree (5). RESULTS The results of the systematic literature review emphasized that the ideal data display maximizes the information communicated while minimizing the cognitive efforts involved with data interpretation. Factors to consider include selecting the correct type of display (e.g. line vs bar graph) and creating simplistic reports. The qualitative and quantitative evaluations of the original and final FTMR revealed improved perceptions of the visual display of the reports and their usability. Themes that emerged from the staff interviews emphasized the value of simplified reports, meaningful data, and usefulness to clinicians. The mean (SD) rating on the Health-ITUES scale when evaluating the original FTMR was 3.86 (0.19) and increased to 4.29 (0.11) when evaluating the revised FTMR (Mann Whitney U Test, z=-12.25, P<0.001). CONCLUSIONS Best practices identified through a systematic review can be applied to create effective reports for clinician use. The lessons learned from evaluating FTMR perceptions and measuring usability can be applied to creating effective reports for clinician use in the context of other implementation science projects.


Author(s):  
Smita Salunke ◽  
David Clapham ◽  
Anjali Agrawal ◽  
Kevin Hughes ◽  
Tony Nunn
Keyword(s):  

2021 ◽  
Vol 13 (2) ◽  
pp. 737
Author(s):  
Indre Siksnelyte-Butkiene ◽  
Dalia Streimikiene ◽  
Tomas Balezentis ◽  
Virgilijus Skulskis

The European Commission has recently adopted the Renovation Wave Strategy, aiming at the improvement of the energy performance of buildings. The strategy aims to at least double renovation rates in the next ten years and make sure that renovations lead to higher energy and resource efficiency. The choice of appropriate thermal insulation materials is one of the simplest and, at the same time, the most popular strategies that effectively reduce the energy demand of buildings. Today, the spectrum of insulation materials is quite wide, and each material has its own specific characteristics. It is recognized that the selection of materials is one of the most challenging and difficult steps of a building project. This paper aims to give an in-depth view of existing multi-criteria decision-making (MCDM) applications for the selection of insulation materials and to provide major insights in order to simplify the process of methods and criteria selection for future research. A systematic literature review is performed based on the Search, Appraisal, Synthesis and Analysis (SALSA) framework and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. In order to determine which MCDM method is the most appropriate for different questions, the main advantages and disadvantages of different methods are provided.


2014 ◽  
Vol 138 (12) ◽  
pp. 1564-1577 ◽  
Author(s):  
Fan Lin ◽  
Zongming Chen

Context Immunohistochemistry has become an indispensable ancillary technique in anatomic pathology laboratories. Standardization of every step in preanalytic, analytic, and postanalytic phases is crucial to achieve reproducible and reliable immunohistochemistry test results. Objective To standardize immunohistochemistry tests from preanalytic, analytic, to postanalytic phases. Data Sources Literature review and Geisinger (Geisinger Medical Center, Danville, Pennsylvania) experience. Conclusions This review article delineates some critical points in preanalytic, analytic, and postanalytic phases; reiterates some important questions, which may or may not have a consensus at this time; and updates the newly proposed guidelines on antibody validation from the College of American Pathologists Pathology and Laboratory Quality Center. Additionally, the article intends to share Geisinger's experience with (1) testing/optimizing a new antibody and troubleshooting; (2) interpreting and reporting immunohistochemistry assay results; (3) improving and implementing a total immunohistochemistry quality management program; and (4) developing best practices in immunohistochemistry.


2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Mariia A. Slepukhina ◽  
Dmitriy V. Ivashchenko ◽  
Maria A. Sheina ◽  
Andranik Alexandrovich Muradian ◽  
Dmitriy Alexeevich Blagovestnov ◽  
...  

AbstractPain is a significant problem in medicine. The use of PGx markers to personalize postoperative analgesia can increase its effectiveness and avoid undesirable reactions. This article describes the mechanisms of nociception and antinociception and shows the pathophysiological mechanisms of pain in the human body. The main subject of this article is pharmacogenetic approach to the selection of anesthetics. Current review presents data for local and general anesthetics, opioids, and non-steroidal anti-inflammatory drugs. None of the anesthetics currently has clinical guidelines for pharmacogenetic testing. This literature review summarizes the results of original research available, to date, and draws attention to this area.


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