scholarly journals Use of Severity Grades to Characterize Histopathologic Changes

2018 ◽  
Vol 46 (3) ◽  
pp. 256-265 ◽  
Author(s):  
Kenneth A. Schafer ◽  
John Eighmy ◽  
James D. Fikes ◽  
Wendy G. Halpern ◽  
Renee R. Hukkanen ◽  
...  
Keyword(s):  
Working Group ◽  
Pathology Report ◽  
Morphologic Change ◽  
Severity Grade ◽  
Hazard Characterization ◽  
Histopathologic Diagnosis ◽  
Regulatory Submissions ◽  
Dose Levels ◽  
Grading Scales ◽  
Selection Of

The severity grade is an important component of a histopathologic diagnosis in a nonclinical toxicity study that helps distinguish treatment-related effects from background findings and aids in determining adverse dose levels during hazard characterization. Severity grades should be assigned based only on the extent (i.e., amount and complexity) of the morphologic change in the examined tissue section(s) and be clearly defined in the pathology report for critical lesions impacting study interpretation. However, the level of detail provided and criteria by which severity grades are assigned can vary, which can lead to inappropriate comparisons and confusion when evaluating pathology results. To help address this issue, a Working Group of the Society of Toxicologic Pathology’s Scientific and Regulatory Policy Committee was formed to provide a “points to consider” article on the assignment and application of pathology severity grades. Overall, the Working Group supports greater transparency and consistency in the reporting of grading scales and provides recommendations to improve selection of diagnoses requiring more detailed severity criteria. This information should enhance the overall understanding by toxicologic pathologists, toxicologists, and regulatory reviewers of pathology findings and thereby improve effective communication in regulatory submissions.

scholarly journals Consensus for the General Use of Equine Water Treadmills for Healthy Horses

Animals ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 305
Author(s):  
Kathryn Nankervis ◽  
Carolyne Tranquille ◽  
Persephone McCrae ◽  
Jessica York ◽  
Morgan Lashley ◽  
...  
Keyword(s):  
Working Group ◽  
Best Practice ◽  
Treadmill Exercise ◽  
Good Practice ◽  
Belt Speed ◽  
Research Programmes ◽  
Potential Benefits ◽  
Water Treadmill ◽  
Selection Of

Water treadmill exercise has become popular in recent years for the training and rehabilitation of equine athletes. In 2019, an equine hydrotherapy working group was formed to establish what was commonly considered to be best practice in the use of the modality. This article describes the process by which general guidelines for the application of water treadmill exercise in training and rehabilitation programmes were produced by the working group. The guidelines describe the consensus reached to date on (1) the potential benefits of water treadmill exercise, (2) general good practice in water treadmill exercise, (3) introduction of horses to the exercise, (4) factors influencing selection of belt speed, water depth and duration of exercise, and (5) monitoring movement on the water treadmill. The long-term goal is to reach a consensus on the optimal use of the modality within a training or rehabilitation programme. Collaboration between clinicians, researchers and experienced users is needed to develop research programmes and further guidelines regarding the most appropriate application of the modality for specific veterinary conditions.

The Role of Microscopy in Preclinical Safety Assessment

2000 ◽  
Vol 6 (S2) ◽  
pp. 998-999
Author(s):  
Barbara J. Dovey-Hartman
Keyword(s):  
Electron Microscopy ◽  
Vital Role ◽  
Pathology Report ◽  
Clinical Phase ◽  
Transmission Electron ◽  
New Chemical Entities ◽  
Regulatory Submissions ◽  
Hematoxylin And Eosin ◽  
Preclinical Safety

Microscopy plays a vital role in assessing the safety of New Chemical Entities (NCE) in the pre-clinical phase of drug development. Light microscopy (LM), transmission electron microscopy (TEM) and scanning electron microscopy (SEM) are used at the Schering-Plough Research Institute (SPRI) for evaluation of NCE. To support regulatory submissions, NCE are routinely tested in rodents in short-term studies such as one-month toxicity studies, and in longterm studies such as oncogenicity studies that may last 24 months. At the completion of a study, the animals are necropsied and the required tissues collected and stored in fixative. The tissues for LM are processed to slides and stained with Hematoxylin and Eosin (H&E). The information derived from the examination of these tissues by LM becomes an essential part of the pathology report. The LM examination of these tissues usually yields the information needed to either progress a NCE or otherwise deter or halt development.

scholarly journals Management of Localized Muscle-Invasive Bladder Cancer from a Multidisciplinary Perspective: Current Position of the Spanish Oncology Genitourinary (SOGUG) Working Group

2021 ◽  
Vol 28 (6) ◽  
pp. 5084-5100
Author(s):  
Antonio Gómez Caamaño ◽  
Ana M. García Vicente ◽  
Pablo Maroto ◽  
Alfredo Rodríguez Antolín ◽  
Julián Sanz ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Working Group ◽  
Checkpoint Inhibitors ◽  
Imaging Techniques ◽  
Clinical Staging ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive ◽  
Selection Of Patients ◽  
Selection Of

This review presents challenges and recommendations on different aspects related to the management of patients with localized muscle-invasive bladder cancer (MIBC), which were discussed by a group of experts of a Spanish Oncology Genitourinary (SOGUG) Working Group within the framework of the Genitourinary Alliance project (12GU). It is necessary to clearly define which patients are candidates for radical cystectomy and which are candidates for undergoing bladder-sparing procedures. In older patients, it is necessary to include a geriatric assessment and evaluation of comorbidities. The pathological report should include a classification of the histopathological variant of MIBC, particularly the identification of subtypes with prognostic, molecular and therapeutic implications. Improvement of clinical staging, better definition of prognostic groups based on molecular subtypes, and identification of biomarkers potentially associated with maximum benefit from neoadjuvant chemotherapy are areas for further research. A current challenge in the management of MIBC is improving the selection of patients likely to be candidates for immunotherapy with checkpoint inhibitors in the neoadjuvant setting. Optimization of FDG-PET/CT reliability in staging of MIBC and the selection of patients is necessary, as well as the design of prospective studies aimed to compare the value of different imaging techniques in parallel.

Selecting and Removing Arbitrators in International Investment Arbitration

2018 ◽  
Vol 2 (4) ◽  
pp. 1-93
Author(s):  
Chiara Giorgetti
Keyword(s):  
European Commission ◽  
Dispute Resolution ◽  
Working Group ◽  
International Investment ◽  
Critical Assessment ◽  
Reform Process ◽  
Policy Issues ◽  
Investment Arbitration ◽  
Selection And Appointment ◽  
Selection Of

AbstractThis book explores and assesses two essential features in investor state dispute resolution (ISDS): the selection and the removal of arbitrators. Both topics have received increasing scrutiny and criticism, that have in turn generated calls for reforms. In its first part, this book explains the selection of arbitrators procedurally and comparatively under the most-often used arbitration rules. It then reviews critically the necessary and desirable qualities for arbitrators’ selection and appointment, and addresses some important and related policy issues, such diversity and repeat appointments. Finally, it discusses the recent calls to review the methodologies used to appoint arbitrators, and specifically the proposal by the European Commission to create a permanent tribunal to resolve international investment disputes, the UNCITRAL Working Group III Reform Process and the rules amendment proposal undertaken by the Secretariat of the International Center for Settlement of Investment Disputes (ICSID Secretariat). In its second part, the book addresses the companion and similarly important issue of challenging and removing arbitrators. It does so by reviewing first the provisions that are appplied under a variety of arbitration rules to remove arbitrators who fail to possess the necessary qualities to sit in arbitral proceedings. It then evaluates the reasons for challenge and discusses some important cases that addressed challenges. The book assesses appointments and removals in a multifaceted and comprehensive way, and includes a critical assessment of the reasons and calls for reform of the ISDS system.

scholarly journals Aerosols of synthetic amorphous silica do not induce fibrosis in lungs after inhalation: Pathology working group review of histopathological specimens from a subchronic 13-week inhalation toxicity study in rats

2018 ◽  
Vol 2 ◽  
pp. 239784731880527
Author(s):  
Klaus Weber ◽  
Axel Bosch ◽  
Mario Bühler ◽  
Chirukandath Gopinath ◽  
Jerry F Hardisty ◽  
...  
Keyword(s):  
Amorphous Silica ◽  
Working Group ◽  
Recovery Period ◽  
Toxicity Study ◽  
Inhalation Toxicity ◽  
Synthetic Amorphous Silica ◽  
Comparative Group ◽  
Quartz Dust ◽  
High Level ◽  
Dose Levels

In a subchronic (13-week) inhalation toxicity study with a terminal sacrifice (after 13 weeks inhalation) and several recovery period sacrifices (13, 26, 39, and 52 weeks), the effects of AEROSIL® 200 (pyrogenic synthetic amorphous silica (SAS)), AEROSIL® R 974 (surface-treated pyrogenic SAS), and SIPERNAT® 22 S (precipitated SAS) were tested in rats at multiple dose levels. The aforementioned materials are all SAS products. A comparative group of animals was exposed to quartz dust. This study attempts to reexamine the lung tissues originally evaluated in a study published by Reuzel et al. using the current standards. To reach a high level of credibility, the results of the reevaluation were subsequently examined by a pathology working group (PWG). In particular, the reevaluating pathologist and the PWG concluded that, even though quartz (crystalline silica) persisted, induced alterations in the lungs following 13 weeks of exposure to amorphous silicas were reversible following 52 weeks of recovery. A long-term adversity has not been established with SAS products. However, quartz dust damages lungs significantly by causing pulmonary fibrosis.

scholarly journals Good practice recommendations for the use of time-lapse technology†

2020 ◽  
Vol 2020 (2) ◽  
Author(s):  
Susanna Apter ◽  
Thomas Ebner ◽  
Thomas Freour ◽  
Yves Guns ◽  
Borut Kovacic ◽  
...  
Keyword(s):  
Clinical Judgment ◽  
Working Group ◽  
Scientific Evidence ◽  
Good Practice ◽  
Time Lapse ◽  
Steering Committee ◽  
Success Rates ◽  
Practice Recommendations ◽  
Use Of Time ◽  
Selection Of

Abstract STUDY QUESTION What recommendations can be provided on the approach to and use of time-lapse technology (TLT) in an IVF laboratory? SUMMARY ANSWER The present ESHRE document provides 11 recommendations on how to introduce TLT in the IVF laboratory. WHAT IS KNOWN ALREADY Studies have been published on the use of TLT in clinical embryology. However, a systematic assessment of how to approach and introduce this technology is currently missing. STUDY DESIGN, SIZE, DURATION A working group of members of the Steering Committee of the ESHRE Special Interest Group in Embryology and selected ESHRE members was formed in order to write recommendations on the practical aspects of TLT for the IVF laboratory. PARTICIPANTS/MATERIALS, SETTING, METHODS The working group included 11 members of different nationalities with internationally recognized experience in clinical embryology and basic science embryology, in addition to TLT. This document is developed according to the manual for development of ESHRE recommendations for good practice. Where possible, the statements are supported by studies retrieved from a PUBMED literature search on ‘time-lapse’ and ART. MAIN RESULTS AND THE ROLE OF CHANCE A clear clinical benefit of the use of TLT, i.e. an increase in IVF success rates, remains to be proven. Meanwhile, TLT systems are being introduced in IVF laboratories. The working group listed 11 recommendations on what to do before introducing TLT in the lab. These statements include an assessment of the pros and cons of acquiring a TLT system, selection of relevant morphokinetic parameters, selection of an appropriate TLT system with technical and customer support, development of an internal checklist and education of staff. All these aspects are explained further here, based on the current literature and expert opinion. LIMITATIONS, REASONS FOR CAUTION Owing to the limited evidence available, recommendations are mostly based on clinical and technical expertise. The paper provides technical advice, but leaves any decision on whether or not to use TLT to the individual centres. WIDER IMPLICATIONS OF THE FINDINGS This document is expected to have a significant impact on future developments of clinical embryology, considering the increasing role and impact of TLT. STUDY FUNDING/COMPETING INTEREST(S) The meetings of the working group were funded by ESHRE. S.A. declares participation in the Nordic Embryology Academic Team with meetings sponsored by Gedeon Richter. T.E. declares to have organized workshops for Esco and receiving consulting fees from Ferring and Gynemed and speakers’ fees from Esco and honorarium from Merck and MSD. T.F. received consulting fees from Vitrolife and Laboratoires Genévrier, speakers’ fees from Merck Serono, Gedeon Richter, MSD and Ferring and research grants from Gedeon Richter and MSD. M.M. received sponsorship from Merck. M.M.E. received speakers’ fees from Merck, Ferring and MSD. R.S. received a research grant from ESHRE. G.C. received speakers’ fees from IBSA and Excemed. The other authors declare that they have no conflict of interest. TRIAL REGISTRATION NUMBER N/A. DISCLAIMER This Good Practice Recommendations (GPR) document represents the views of ESHRE, which are the result of consensus between the relevant ESHRE stakeholders and are based on the scientific evidence available at the time of preparation. ESHRE’s GPRs should be used for information and educational purposes. They should not be interpreted as setting a standard of care or be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results. They do not replace the need for application of clinical judgment to each individual presentation, nor variations based on locality and facility type. Furthermore, ESHRE GPRs do not constitute or imply the endorsement, or favouring of any of the included technologies by ESHRE. †ESHRE Pages content is not externally peer reviewed. The manuscript has been approved by the Executive Committee of ESHRE.

Remission in Rheumatoid Arthritis: Working Toward Incorporation of the Patient Perspective at OMERACT 12

2015 ◽  
Vol 43 (1) ◽  
pp. 203-207 ◽  
Author(s):  
Lilian H. van Tuyl ◽  
Martina Sadlonova ◽  
Bev Davis ◽  
Caroline Flurey ◽  
Niti Goel ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Qualitative Research ◽  
Health Professionals ◽  
Working Group ◽  
Research Agenda ◽  
Patient Perspective ◽  
Disease Flare ◽  
Methodological Challenges ◽  
Disease Questionnaire ◽  
Selection Of

Objective.The treatment of rheumatoid arthritis (RA) should target patient-relevant outcomes, making patient perspective on remission essential. In 2010, patients, physicians, health professionals, and researchers at the Outcome Measures in Rheumatology (OMERACT) conference developed an ambitious research agenda to study the concept of remission. Qualitative research has since helped us understand the concept of remission from the patient perspective.Methods.During OMERACT 12, the OMERACT working group on patient perspective on remission in RA elaborated on data generated to date and discussed the methodological challenges ahead. Challenges included (1) selection of domains, (2) choice of a patient remission definition or a single domain to add to the current remission definition, and (3) the importance of pain in defining remission from a patient perspective.Results.Focus in the coming years will be on increasing our understanding by identifying the most important domains from the patient perspective regarding remission and investigating how these domains can be measured. Investigation into the Rheumatoid Arthritis Impact of Disease questionnaire, disease flare, as well as the concordance of domains from our ongoing remission survey is appropriate. More data and further discussions are needed to decide on the next steps.Conclusion.Progress summarized over 4 years highlights the main methodological challenges discussed within the working group on patient perspective on remission in RA during OMERACT 12.

scholarly journals Using indicators for evaluating, comparing, and communicating the ecological status of exploited marine ecosystems. 2. Setting the scene

2010 ◽  
Vol 67 (4) ◽  
pp. 692-716 ◽  
Author(s):  
Yunne-Jai Shin ◽  
Lynne J. Shannon ◽  
Alida Bundy ◽  
Marta Coll ◽  
Kerim Aydin ◽  
...  
Keyword(s):  
Working Group ◽  
Marine Ecosystem ◽  
Ecological Status ◽  
Ecological Indicators ◽  
Ecosystem Approach ◽  
Marine Ecosystems ◽  
Comparative Approach ◽  
Insufficient Data ◽  
Ecosystem Drivers ◽  
Selection Of

Abstract Shin, Y-J., Shannon, L. J., Bundy, A., Coll, M., Aydin, K., Bez, N., Blanchard, J. L., Borges, M. F., Diallo, I., Diaz, E., Heymans, J. J., Hill, L., Johannesen, E., Jouffre, D., Kifani, S., Labrosse, P., Link, J. S., Mackinson, S., Masski, H., Möllmann, C., Neira, S., Ojaveer, H., ould Mohammed Abdallahi, K., Perry, I., Thiao, D., Yemane, D., and Cury, P. M. 2010. Using indicators for evaluating, comparing, and communicating the ecological status of exploited marine ecosystems. 2. Setting the scene. – ICES Journal of Marine Science, 67: 692–716. Background is provided to the selection of ecological indicators by the IndiSeas Working Group, and the methodology adopted for analysis and comparison of indicators across exploited marine ecosystems is documented. The selected indicators are presented, how they are calculated is explained, and the philosophy behind the comparative approach is given. The combination of selected indicators is intended to reflect different dynamics, tracking processes that display differential responses to fishing, and is meant to provide a complementary means of assessing marine ecosystem trends and states. IndiSeas relied on inputs and insights provided by the local experts from participating ecosystems, helping to understand state and trend indicators and to disentangle the effect of other potential ecosystem drivers, such as climate variability. This project showed that the use of simple and available indicators under an ecosystem approach can achieve a real, wide-reaching evaluation of marine ecosystem status caused by fishing. This is important because the socio-economics of areas where fishing activities develop differs significantly around the globe, and in many countries, insufficient data are available for complex and exhaustive analyses.

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