World health organisation inter-laboratory comparison study in 12 countries on quality performance of nuclear medicine imaging devices

1985 ◽  
Vol 10-10 (5-6) ◽  
Author(s):  
V. Volodin ◽  
G. Souchkevitch ◽  
N. Racoveanu ◽  
H. Bergmann ◽  
E. Busemann-Sokole ◽  
...  
Keyword(s):  
Nuclear Medicine ◽  
World Health Organisation ◽  
World Health ◽  
Comparison Study ◽  
Nuclear Medicine Imaging ◽  
Quality Performance

scholarly journals Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Almir Badnjević ◽  
Lejla Gurbeta Pokvić ◽  
Zijad Džemić ◽  
Fahir Bečić
Keyword(s):  
World Health Organisation ◽  
High Rate ◽  
World Health ◽  
Risk Level ◽  
Mechanical Ventilators ◽  
Quality Performance ◽  
Native Languages ◽  
Medical Products ◽  
Regulatory Bodies ◽  
National Regulatory Agency

Abstract Background The world is facing an unprecedented outbreak affecting all aspects of human lives which is caused by the COVID-19 pandemic. Due to the virus novelty, healthcare systems are challenged by a high rate of patients and the shortage of medical products. To address an increased need for essential medical products, national authorities, worldwide, made various legislative concessions. This has led to essential medical products being produced by automotive, textile and other companies from various industries and approved under the emergency use authorizations or legal concessions of national regulatory bodies. This paper presents a narrative commentary of the available documentation on emergency use authorizations and legal concessions for medical products during COVID-19 pandemic. Methodology The basis for narrative commentary includes scientific articles published in Web of Science, Scopus, PubMed and Embase databases, official publications of international organizations: Food and Drug Agency (FDA), World Health Organisation (WHO), World Bank and United Nations (UN), and national regulatory agency reports in native languages (English, German, Bosnian, and Croatian) published from November 1, 2019 to May 1, 2020. This paper focuses on three types of essential medical products: mechanical ventilators, personal protective equipment (PPE) and diagnostic tests. Evidence-informed commentary of available data and potential identified risks of emergency use authorizations and legal concessions is presented. Discussion It is recognized that now more than ever, raising global awareness and knowledge about the importance of respecting the essential requirements is needed to guarantee the appropriate quality, performance and safety of medical products, especially during outbreak situation, such as the COVID-19 pandemic. Emergency use authorizations for production, import and approval of medical products should be strictly specified and clearly targeted from case to case and should not be general or universal for all medical products, because all of them are associated with different risk level. Conclusion Presented considerations and experiences should be taken as a guide for all possible future outbreak situations to prevent improvised reactions of national regulatory bodies.

Patients with fever of unknown origin (FUO): diagnosis by nuclear medicine imaging

2001 ◽  
Vol 40 (03) ◽  
pp. 59-70 ◽  
Author(s):  
W. Becker ◽  
J. Meiler
Keyword(s):  
Nuclear Medicine ◽  
Fever Of Unknown Origin ◽  
Tumor Imaging ◽  
White Blood Cells ◽  
Unknown Origin ◽  
Final Diagnosis ◽  
Recurrent Fever ◽  
Nuclear Medicine Imaging

SummaryFever of unknown origin (FUO) in immunocompetent and non neutropenic patients is defined as recurrent fever of 38,3° C or greater, lasting 2-3 weeks or longer, and undiagnosed after 1 week of appropriate evaluation. The underlying diseases of FUO are numerous and infection accounts for only 20-40% of them. The majority of FUO-patients have autoimmunity and collagen vascular disease and neoplasm, which are responsible for about 50-60% of all cases. In this respect FOU in its classical definition is clearly separated from postoperative and neutropenic fever where inflammation and infection are more common. Although methods that use in-vitro or in-vivo labeled white blood cells (WBCs) have a high diagnostic accuracy in the detection and exclusion of granulocytic pathology, they are only of limited value in FUO-patients in establishing the final diagnosis due to the low prevalence of purulent processes in this collective. WBCs are more suited in evaluation of the focus in occult sepsis. Ga-67 citrate is the only commercially available gamma emitter which images acute, chronic, granulomatous and autoimmune inflammation and also various malignant diseases. Therefore Ga-67 citrate is currently considered to be the tracer of choice in the diagnostic work-up of FUO. The number of Ga-67-scans contributing to the final diagnosis was found to be higher outside Germany than it has been reported for labeled WBCs. F-l 8-2’-deoxy-2-fluoro-D-glucose (FDG) has been used extensively for tumor imaging with PET. Inflammatory processes accumulate the tracer by similar mechanisms. First results of FDG imaging demonstrated, that FDG may be superior to other nuclear medicine imaging modalities which may be explained by the preferable tracer kinetics of the small F-l 8-FDG molecule and by a better spatial resolution of coincidence imaging in comparison to a conventional gamma camera.

A Collaborative Study to Establish the Second International Standard for Streptokinase

1990 ◽  
Vol 64 (02) ◽  
pp. 267-269 ◽  
Author(s):  
A B Heath ◽  
P J Gaffney
Keyword(s):  
High Purity ◽  
Collaborative Study ◽  
World Health Organisation ◽  
World Health ◽  
Clot Lysis ◽  
Current Standard ◽  
International Standard ◽  
Accelerated Degradation ◽  
The World ◽  
International Collaborative Study

SummaryAn International Standard for Streptokinase - Streptodomase (62/7) has been used to calibrate high purity clinical batches of SK since 1965. An international collaborative study, involving six laboratories, was undertaken to replace this standard with a high purity standard for SK. Two candidate preparations (88/826 and 88/824) were compared by a clot lysis assay with the current standard (62/7). Potencies of 671 i.u. and 461 i.u. were established for preparations A (88/826) and B (88/824), respectively.Either preparation appeared suitable to serve as a standard for SK. However, each ampoule of preparation A (88/826) contains a more appropriate amount of SK activity for potency testing, and is therefore preferred. Accelerated degradation tests indicate that preparation A (88/826) is very stable.The high purity streptokinase preparation, coded 88/826, has been established by the World Health Organisation as the 2nd International Standard for Streptokinase, with an assigned potency of 700 i.u. per ampoule.

A Collaborative Study to Establish an International Standard for Alpha-Thrombin

1992 ◽  
Vol 67 (04) ◽  
pp. 424-427 ◽  
Author(s):  
P J Gaffney ◽  
A B Heath ◽  
J W Fenton II
Keyword(s):  
Elevated Temperatures ◽  
Collaborative Study ◽  
World Health Organisation ◽  
Significant Loss ◽  
Thrombin Inhibitors ◽  
World Health ◽  
Expert Committee ◽  
International Standard ◽  
Assay Procedure ◽  
And Control

SummarySince 1975 an International Standard for Thrombin of low purity has been used. While this standard was stable and of value for calibrating thrombins of unknown potency the need for a pure a-thrombin standard arose both for accurate calibration and for precise measurement of thrombin inhibitors, notably hirudin. An international collaborative study was undertaken to establish the potency and stability of an ampouled pure a-thrombin preparation. A potency of 97.5 international units (95% confidence limits 86.5-98.5) was established for the new a-thrombin standard (89/ 588) using a clotting-assay procedure. Stability data at various elevated temperatures indicated that the standard could be transported and stored with no significant loss of potency.Ampoules of lyophilised a-thrombin (coded 89/588) have been recommended as an International Standard for a-thrombin with an assigned potency of 100 international units per ampoule by the International Society for Thrombosis and Haemostasis (Thrombin and its Inhibitors Sub-Committee) in Barcelona, Spain in July 1990 while the Expert Committee on Biological Standardisation and Control of the World Health Organisation will consider its status at its next meeting in Geneva in 1991.

ANTARA SUNNAH DAN TRADISI (Khitan Muallaf Perempuan Baligh di Jayapura, Papua)

1970 ◽  
Vol 9 (2) ◽  
pp. 271-284
Author(s):  
Hendra Yulia Rahman
Keyword(s):  
World Health Organisation ◽  
World Health

Masyarakat Indonesia pada umumnya khususnya yang bergama Islam, memiliki kebiasaan mengkhitankan anak perempuannya dan memandang ini sebagai sunnah, hal ini juga dilakukan masyarakat di negara-negara lain yang memiliki penduduk pemeluk agama Islam. Pada umumnya masyarakat megkhitankan anak perempuannya, ketika masih bayi dan meyakininya sebagai bentuk kewajiban dari perintah agama. Badan kesehatan dunia World Health Organisation (WHO) melakukan pelarangan segala bentuk khitan pada perempuan, karena dianggap sebagai bentuk kekerasan pada perempuan dengan menyakiti dan merusak alat reproduksi perempuan. Khitan perempuan dianggap sebagai tradisi yang sudah lama ada tengah-tengah masyarakat baik yang muslim maupun yang non muslim, yang dalam pelaksanaannya lebih dimaksudkan sebagai upaya pengontrolan seksualitas perempuan. Muallaf perempuan baligh khususnya di wilayah kota Jayapura, Papua rata-rata melakukan khitan, yang menurut mereka merupakan bagian dari perintah agama. Bahwasanya khitan muallaf perempuan baligh di kota Jayapaura merupakan sebuah tradisi yang terus berlangsung, dan tradisi tersebut sejalan dengan sunnah.

Comparative docking of SARS-CoV-2 receptors antagonists from repurposing drugs

2020 ◽  
Author(s):  
Micael Davi Lima de Oliveira ◽  
Kelson Mota Teixeira de Oliveira
Keyword(s):  
World Health Organisation ◽  
World Health ◽  
Lung Cells ◽  
The Novel ◽  
High Modulation ◽  
Main Protease ◽  
The World ◽  
Novel Coronavirus ◽  
Viral Receptors ◽  
Theoretical Results

According to the World Health Organisation, until 16 June, 2020, the number of confirmed and notified cases of COVID-19 has already exceeded 7.9 million with approximately 434 thousand deaths worldwide. This research aimed to find repurposing antagonists, that may inhibit the activity of the main protease (Mpro) of the SARS-CoV-2 virus, as well as partially modulate the ACE2 receptors largely found in lung cells, and reduce viral replication by inhibiting Nsp12 RNA polymerase. Docking molecular simulations were performed among a total of 60 structures, most of all, published in the literature against the novel coronavirus. The theoretical results indicated that, in comparative terms, paritaprevir, ivermectin, ledipasvir, and simeprevir, are among the most theoretical promising drugs in remission of symptoms from the disease. Furthermore, also corroborate indinavir to the high modulation in viral receptors. The second group of promising drugs includes remdesivir and azithromycin. The repurposing drugs HCQ and chloroquine were not effective in comparative terms to other drugs, as monotherapies, against SARS-CoV-2 infection.

Osseointegrated Implants: A Comprehensive Review

2021 ◽  
Vol 2 (1) ◽  
pp. 24-30
Author(s):  
Matheus Marquez Cruvinel Santos ◽  
◽  
Flávio Barros da Silva ◽  
Idiberto José Zotarelli-Filho ◽  
Elias Naim Kassis ◽  
...  
Keyword(s):  
Dental Implants ◽  
Pharmacological Action ◽  
World Health Organisation ◽  
World Health ◽  
Density Level ◽  
Mineral Density ◽  
Osseointegrated Implants ◽  
Bone Mineral Density Level ◽  
The Mean ◽  
Normal Women

The most common bone disorder found by implant dentists is osteoporosis, which is a systemic skeletal disorder associated with aging, which is characterized by loss of bone mass, making bones fragile and more susceptible to fractures. The World Health Organisation has defined osteoporosis as a bone mineral density level greater than 2.5 standard deviations below the mean of young normal women. After 60 years of age, a third of the population have this disorder, it occurs twice as often in women than in men. It is estimated that 1.3 million fractures and 133,000 all hip fractures occur every year as a result of osteoporosis. This study aimed to discuss aspects of the pharmacological action of Bisphosphonates (BP) and their influence on the bone tissue when associated with treatment with dental implants. There are several types of treatments that prevent or prevent the progression of osteoporosis. So, BP, such as alendronate, are inhibitors of bone resorption. Act as controlling the development of osteoporosis by increasing the process of bone density and decrease its reabsorption, often acting as supporting the process of osseointegration of dental implants.

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