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1.
Arch Pathol Lab Med ; 144(10): 1199-1203, 2020 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-33002152

RESUMO

CONTEXT.­: The burden of chronic kidney disease in Indigenous Australians is 7.3 times higher than that of non-Indigenous Australians. If chronic kidney disease is detected early and managed, deterioration in kidney function can be reduced. Urine albumin to creatinine ratio is a key marker of early renal damage. OBJECTIVE.­: To report on 16 years of analytic quality of urine albumin to creatinine ratio testing on Siemens DCA devices enrolled in the national Quality Assurance for Aboriginal and Torres Strait Islander Medical Services point-of-care testing program. DESIGN.­: Quality Assurance for Aboriginal and Torres Strait Islander Medical Services participants are required to test 2 quality assurance samples each month across two 6-monthly testing cycles per year. Participants also test 2 quality control samples monthly. RESULTS.­: The percentage of urine albumin, creatinine, and albumin to creatinine ratio results for quality assurance point-of-care testing that were within assigned allowable limits of performance averaged 96.9%, 95.9%, and 97.5%, respectively. The percentage acceptable quality control results for urine albumin and creatinine averaged 93.5% and 86.8%. The median imprecision for urine albumin, creatinine, and albumin to creatinine ratio quality assurance testing averaged 5.5%, 4.1%, and 3.3%, respectively, and the median within-site imprecision for quality control testing averaged 5.4%, 4.3%, and 5.7%, respectively, for the low sample and 4.0%, 4.1%, and 4.5%, respectively, for the high sample. CONCLUSIONS.­: For 16 years the DCA system has proven to be reliable and robust and operators at Aboriginal medical services have demonstrated they are able to conduct point-of-care testing for urine albumin to creatinine ratio that consistently meets analytic performance standards.


Assuntos
Albuminúria/urina , Creatinina/urina , Testes Imediatos , Insuficiência Renal Crônica/diagnóstico , Austrália , Humanos , Grupo com Ancestrais Oceânicos , Garantia da Qualidade dos Cuidados de Saúde , Controle de Qualidade , Insuficiência Renal Crônica/urina , Urinálise
2.
J Med Libr Assoc ; 108(4): 656-662, 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-33013228

RESUMO

Since January 30, 2020, when the World Health Organization declared the SARS CoV-2 disease (COVID-19) to be a public health emergency of international concern, the National Library of Medicine's (NLM's) Web Collecting and Archiving Working Group has been collecting a broad range of web-based content about the emerging pandemic for preservation in an Internet archive. Like NLM's other Global Health Events web collections, this content will have enduring value as a multifaceted historical record for future study and understanding of this event. This article describes the scope of the COVID-19 project; some of the content captured from websites, blogs, and social media; collecting criteria and methods; and related COVID-19 collecting efforts by other groups. The growing collection-2,500 items as of June 30, 2020-chronicles the many facets of the pandemic: epidemiology; vaccine and drug research; disease control measures and resistance to them; effects of the pandemic on health care institutions and workers, education, commerce, and many aspects of social life; effects for especially vulnerable groups; role of health disparities in infection and mortality; and recognition of racism as a public health emergency.


Assuntos
Arquivos , Infecções por Coronavirus/epidemiologia , Curadoria de Dados , National Library of Medicine (U.S.) , Pneumonia Viral/epidemiologia , Betacoronavirus , Coleta de Dados , Saúde Global , Humanos , Pandemias , Controle de Qualidade , Estados Unidos
4.
Medicina (Kaunas) ; 56(9)2020 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-32867260

RESUMO

The positive impact of probiotic strains on human health has become more evident than ever before. Often delivered through food, dietary products, supplements, and drugs, different legislations for safety and efficacy issues have been prepared. Furthermore, regulatory agencies have addressed various approaches toward these products, whether they authorize claims mentioning a disease's diagnosis, prevention, or treatment. Due to the diversity of bacteria and yeast strains, strict approaches have been designed to assess for side effects and post-market surveillance. One of the most essential delivery systems of probiotics is within food, due to the great beneficial health effects of this system compared to pharmaceutical products and also due to the increasing importance of food and nutrition. Modern lifestyle or various diseases lead to an imbalance of the intestinal flora. Nonetheless, as the amount of probiotic use needs accurate calculations, different factors should also be taken into consideration. One of the novelties of this review is the presentation of the beneficial effects of the administration of probiotics as a potential adjuvant therapy in COVID-19. Thus, this paper provides an integrative overview of different aspects of probiotics, from human health care applications to safety, quality, and control.


Assuntos
Infecções por Coronavirus/prevenção & controle , Suplementos Nutricionais/normas , Gastroenteropatias/terapia , Hepatopatias/terapia , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Probióticos/uso terapêutico , Betacoronavirus , Doença Celíaca/terapia , Infecções por Clostridium/terapia , Constipação Intestinal/terapia , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/terapia , Transtorno Depressivo/terapia , Doenças Diverticulares/terapia , Disenteria/terapia , Enterocolite Necrosante/terapia , Alimentos e Bebidas Fermentados , Hipersensibilidade Alimentar/terapia , Infecções por Helicobacter/terapia , Encefalopatia Hepática/terapia , Humanos , Doenças Inflamatórias Intestinais/terapia , Hepatopatia Gordurosa não Alcoólica/terapia , Pneumonia Viral/terapia , Probióticos/efeitos adversos , Probióticos/normas , Controle de Qualidade
5.
Georgian Med News ; (304-305): 163-169, 2020.
Artigo em Russo | MEDLINE | ID: mdl-32965269

RESUMO

The purpose of the study - scientific justification, development and implementation of an automated information system for assessing the results of the examination of quality and technology of medical care in hospitals at the regional level.; Based on the developed unified expert map for assessing the quality and technology of medical care, a mathematical model is built and the quantification method is used to form a unified regional system for automated monitoring of the quality of medical care in hospitals. The use of this system of monitoring the quality of medical care allows using the statistical methods to manage the quality of care ; to form homogeneous groups of patients according to specific parameters (nozology, gender, age, severity of condition, etc.) and evaluate the quality of the Health Care provided to them; monitor and conduct a comparative analysis of the quality health care in the work of individual doctors, structural divisions, and for institution as a whole, create a database of results carried out according to a unified.; The quality of the diagnostic and treatment process is characterized by many quantitative indicators. The formation of seven groups of process indicators from the number of questions included in the developed formalized expert map concentrates the attention of experts on the main logical stages of medical activity, optimizes decision-making on eliminating identified defects and objectifies collegial management of the level of professional activity of a medical institution.; Using a mathematical model and a quantification method to create an automated information-analytical system for monitoring the quality of medical care allows us to evaluate the qualitative features in quantitative terms. The unified technology for conducting examinations allows you to coordinate expert work at the intra-departmental and extra-departmental levels, carry out cross-expertise and determine the reliability of the examination.; The introduction of formalization in the work on examination of hospital quality and the use of an automated system for monitoring the quality of medical care, allows using statistical methods to generate specific ones. parameters (nozology, gender, age, severity of condition, etc.) are homogeneous groups of patients and assess the quality of care provided to them to monitor and conduct a comparative analysis of the work of individual doctors, structural divisions, the institution as a whole create a database of the results of the examinations carried out by a single technology in all medical institutions at the regional level.; A dynamic analysis of the quality of medical care in hospitals revealed the presence of a significant reserve for its further improvement. The greatest number of defects in the organization and technology of medical care is noted in two blocks: the quality of medical records and diagnostic measures.


Assuntos
Infecções por Coronavirus , Hospitais , Pandemias , Pneumonia Viral , Betacoronavirus , República da Geórgia/epidemiologia , Humanos , Controle de Qualidade , Reprodutibilidade dos Testes
7.
Vaccine ; 38(44): 6882-6888, 2020 10 14.
Artigo em Inglês | MEDLINE | ID: mdl-32912643

RESUMO

INTRODUCTION: The Changchun Changsheng Vaccine Incident (CCVI) occurred mid-2018 and involved irregularities in the manufacture and quality control of diphtheria-tetanus-acellular-pertussis and rabies vaccines. This study investigates vaccine confidence amongst Chinese caregivers and vaccination-service providers (VSPs) six months after the CCVI. METHODS: Quantitative surveys were conducted in January 2019 with 2124 caregivers of children and 555 VSPs in three areas in China. The proportions of respondents who agreed to the four statements from the Vaccine Confidence Index™ were used to measure vaccine confidence. Descriptive and univariate analyses were performed to study the level of vaccine confidence. Semi-structured interviews were conducted with 48 caregivers, 43 VSPs and 9 immunization program managers. Interviews were analyzed thematically using a combination of deductive and inductive coding. Media surveillance was conducted to monitor public responses to the CCVI. RESULTS: Media surveillance indicated that public attention to vaccine-related issues increased sharply immediately post-CCVI but declined rapidly thereafter. Six months post-CCVI, 96.0% of caregivers and the same proportion of VSPs reported that vaccination was important and compatible with their religious beliefs. 82.7% and 88.2% of caregivers agreed that vaccines were safe and effective. 92.8% and 94.6% of VSPs agreed that vaccines were safe and effective. Both caregivers and VSPs reported an immediate decline in vaccine confidence post-CCVI. In most cases this trust was regained over time following government and public health responses, however some people remained hesitant about vaccinating their children. Many VSPs were overwhelmed by consultations, workload and psychological pressure after the CCVI. CONCLUSION: After an initial decline, vaccine confidence recovered to pre-incident levels six months after the CCVI. However, some caregivers moved from the higher to the lower end of the vaccine confidence spectrum, pointing to the need to promote the acceptance of vaccination especially given the need for new vaccines to control the coronavirus epidemic.


Assuntos
Cuidadores/psicologia , Corpo Clínico/psicologia , Controle de Qualidade , Retirada de Medicamento Baseada em Segurança , Confiança/psicologia , Adulto , China , Estudos Transversais , Vacinas contra Difteria, Tétano e Coqueluche Acelular/efeitos adversos , Feminino , Humanos , Programas de Imunização , Masculino , Pessoa de Meia-Idade , Vacinas Antirrábicas/efeitos adversos , Inquéritos e Questionários , Vacinação/estatística & dados numéricos , Recusa de Vacinação/psicologia
8.
Western Pac Surveill Response J ; 11(1): 41-46, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32963890

RESUMO

Problem: Emerging bacterial antimicrobial (antibiotic) resistance (AMR) is a global threat to human health. However, most lower income countries do not have microbiological diagnostic testing for prompt, reliable confirmation of bloodstream infection and identification of AMR. Context: Clinicians in Pacific island nations are increasingly challenged by patients who have infection due to antimicrobial-resistant bacteria. Treatment of infection remains empirical because of a lack of diagnostic testing capacity and may follow guidelines that were formulated without reference to local measures of AMR prevalence. There is limited understanding among clinicians of microbiology testing and test interpretation. Action: Examine the lessons learnt from pilot laboratory development programmes in two Pacific island nations that focused on establishing standard procedures for micrological diagnostics and antimicrobial susceptibility testing (AST) and on improving the training of clinicians to increase their use of laboratory services. Outcome: The pilot programmes addressed a range of logistical difficulties and evaluated two blood culture systems. They also examined and improved internal QC implementation and evaluated the prevalence of AMR. Discussion: Continued development of microbiological diagnostic capability in the Pacific region is paramount. Pacific Island nations need to develop the capability of at least one central laboratory to culture AMR pathogens and subject them to quality-controlled AST or arrange for suitable referral to a nearby country. Discussion: This study demonstrated a persistently high prevalence of three major bacterial STIs across four countries in WHO's Western Pacific Region during nearly two decades. Further strengthening of strategies to control and prevent STIs is warranted.


Assuntos
Antibacterianos/farmacologia , Técnicas Bacteriológicas/normas , Farmacorresistência Bacteriana , Testes de Sensibilidade Microbiana/normas , Técnicas de Diagnóstico Molecular/normas , Humanos , Ilhas do Pacífico , Projetos Piloto , Controle de Qualidade
9.
Zhongguo Zhong Yao Za Zhi ; 45(15): 3681-3688, 2020 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-32893558

RESUMO

This study aims to explore the change laws of water absorption in Chinese herbal pieces and establish the prediction model of relative density for Chinese medicine compound decoction. Firstly, fitted equations of water absorption and decocting time was established by observing the change laws of water absorption in 36 kinds of Chinese herbal pieces in 12 groups(according to the drug-parts) with decocting time. The r value of the mineral group and other type group was 0.691 2 and 0.663 3, respectively. The r value of the remaining 10 groups was 0.802 2-0.925 4. All P values were less than 0.05(n=21). The formula of the amount of water added was optimized by combining the fitted equations with determined water absorption, and the liquid yield could be controlled in a range of 100%±10%. Secondly, it was determined that the liquid density tester could be used for the rapid determination of relative density of Chinese medicine decoction after methodological study and comparison with the pycnometer method. The linear regression equation between the corrected relative density(y) and extraction ratio(%, x) was built by measuring and analyzing the related parameters such as liquid yield, relative density and extraction ratio in 46 kinds of Chinese herbal pieces. The established equation was y=0.041 3x+1.003 7, r=0.930 9(P <0.01, n=46), with linear range of 1.94%-65.75%. Based on this, the prototype model for predicting relative density of Chinese medicine decoction was established, and the relative densities of 8 Chinese medicine decoctions were within the prediction interval of this model in verification. This study lays a foundation for database construction of Chinese medicine decoction, implementation of personalized decocting mode and rapid quality control of Chinese medicine decoction.


Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Controle de Qualidade , Gravidade Específica , Água
10.
Artigo em Inglês | PAHO-IRIS | ID: phr-52782

RESUMO

[ABSTRACT]. Objective. To assess all the incidents of substandard, falsified and unregistered medicines in 2017 and 2018 in Latin America, determining the types of products affected, stages of the supply chain in which incidents were detected, quality deviations identified in tested samples, and regulatory measures taken by authorities. Methods. A comprehensive search of the websites of the Latin American national regulatory authorities was conducted, identifying all eligible incidents during 2017-2018. Standardized values were collected from each incident for pre-determined variables: country, year, type of incident, therapeutic group, supply chain, regulatory measures and laboratory data. Results. A total of 596 incidents in 13 countries were included (236 substandard, 239 falsified, 116 unregistered and 5 stolen). The therapeutic categories with the highest incidents were: anti-infectives, medicines for pain/palliative care, hormones/contraceptives, medicines for the respiratory tract, and medicines for mental/behavioural disorders. The most common places where incidents were detected were commercial establishments, pharmacies, health services and manufacturers. The most recurrent quality deviations were failure in parameters (appearance or physicochemical), incorrect labelling, different quantity of active pharmaceutical ingredient, presence of unknown particles, and microbiological contamination. The most frequent regulatory measures identified were alerts, withdrawals, seizures, and prohibition of marketing/distribution/use. Conclusions. In Latin America, substandard, falsified and unregistered medicines persist as a highly prevalent problem. An advanced degree of regulatory development in countries is associated with higher incident detection/reporting rates and a more comprehensive set of measures. The pharmaceutical supply chain is more vulnerable in its final node. Quality deviations identified in tested samples pose serious risks to public health.


[RESUMEN]. Objetivo. Evaluar todos los incidentes de medicamentos de calidad subestándar, falsificados y no registrados en 2017 y 2018 en América Latina, y determinar los tipos de productos afectados, los puntos de la cadena de suministro en los que se detectaron incidentes, las desviaciones de calidad identificadas en las muestras analizadas y las medidas regulatorias adoptadas por las autoridades. Métodos. Se realizó una búsqueda exhaustiva en los sitios web de las autoridades regulatorias nacionales de América Latina y se identificaron todos los incidentes elegibles publicados durante 2017 y 2018. Se recogieron valores estandarizados de cada incidente conforme a variables predeterminadas: país, año, tipo de incidente, grupo terapéutico, cadena de suministro, medidas regulatorias, y datos de laboratorio. Resultados. Se incluyeron en total 596 incidentes de 13 países (236 relacionados con calidad subestándar, 239 falsificados, 116 no registrados y 5 robados). Las categorías terapéuticas con mayor número de incidentes fueron los agentes antiinfecciosos, los medicamentos para el dolor/cuidados paliativos, las hormonas/anticonceptivos, los medicamentos para las vías respiratorias y los medicamentos para trastornos mentales/del comportamiento. Los lugares más comunes en los que se detectaron incidentes fueron los establecimientos comerciales, las farmacias, los servicios de salud y los fabricantes. Las fallas de calidad más recurrentes fueron deficiencia de los parámetros (fisicoquímicos, o el aspecto), etiquetado incorrecto, cantidad diferente del principio activo, presencia de partículas desconocidas y contaminación microbiológica. Las medidas regulatorias identificadas con más frecuencia fueron las alertas, los retiros e incautaciones del producto, y la prohibición de su comercialización, distribución o uso. Conclusiones. En América Latina, los medicamentos de calidad subestándar, falsificados y no registrados continúan siendo un problema frecuente. Un desarrollo regulatorio avanzado se asocia con tasas más altas de detección y notificación de incidentes, y un conjunto más amplio de medidas en los países. La cadena de suministro farmacéutico es más vulnerable en su último eslabón. Las desviaciones de calidad identificadas en las muestras analizadas plantean graves riesgos para la salud pública.


Assuntos
Medicamentos Falsificados , Medicamentos Fora do Padrão , Controle de Qualidade , Preparações Farmacêuticas , Comercialização de Medicamentos , América Latina , Medicamentos Falsificados , Medicamentos Fora do Padrão , Controle de Qualidade , Preparações Farmacêuticas , Comercialização de Medicamentos , América Latina
11.
Rev Panam Salud Publica ; 44, sept. 2020
Artigo em Espanhol | PAHO-IRIS | ID: phr-52282

RESUMO

[RESUMEN]. Objetivo. El objetivo es presentar los resultados del Programa Latinoamericano de Aseguramiento de la Calidad en Bacteriología y Resistencia a los Antimicrobianos (LA-EQAS) entre 2000 y 2018 y la evolución en la detección de mecanismos de resistencia de impacto clínico. Métodos. Los Laboratorios Nacionales de Referencia (LNR) participantes recibieron 25 encuestas con 10 cepas cada una, representando un total de 86 especies bacterianas y 40 mecanismos de resistencia. Para evaluar el desempeño de los LNR, se analizaron cinco indicadores: identificación bacteriana, interpretación de las pruebas de sensibilidad, rangos de las zonas de inhibición aceptables, mecanismo de resistencia inferido, y tiempo de demora en la respuesta. Resultados. La concordancia media fue 82,6% (rango: 74-95%) en la identificación bacteriana, 93,3% (85-98%) en la interpretación de las pruebas de sensibilidad, 84,6% (70-94%) en las zonas de inhibición, 82,5% (73-96%) en el mecanismo de resistencia inferido, y la demora en la respuesta, 34 días. Se observó una mejora en la detección de mecanismos de relevancia clínica como resistencia a meticilina, macrólidos y glucopéptidos en cocos gram positivos, y betalactamasas de espectro extendido, AmpC plasmídico y carbapenemasas en bacilos gram negativos. Conclusiones. El LA-EQAS es una excelente herramienta para la mejora continua de la calidad en el diagnóstico de las infecciones por microorganismos multirresistentes en los LNR de América Latina.


[RESUMEN]. Objetivo. El objetivo es presentar los resultados del Programa Latinoamericano de Aseguramiento de la Calidad en Bacteriología y Resistencia a los Antimicrobianos (LA-EQAS) entre 2000 y 2018 y la evolución en la detección de mecanismos de resistencia de impacto clínico. Métodos. Los Laboratorios Nacionales de Referencia (LNR) participantes recibieron 25 encuestas con 10 cepas cada una, representando un total de 86 especies bacterianas y 40 mecanismos de resistencia. Para evaluar el desempeño de los LNR, se analizaron cinco indicadores: identificación bacteriana, interpretación de las pruebas de sensibilidad, rangos de las zonas de inhibición aceptables, mecanismo de resistencia inferido, y tiempo de demora en la respuesta. Resultados. La concordancia media fue 82,6% (rango: 74-95%) en la identificación bacteriana, 93,3% (85-98%) en la interpretación de las pruebas de sensibilidad, 84,6% (70-94%) en las zonas de inhibición, 82,5% (73-96%) en el mecanismo de resistencia inferido, y la demora en la respuesta, 34 días. Se observó una mejora en la detección de mecanismos de relevancia clínica como resistencia a meticilina, macrólidos y glucopéptidos en cocos gram positivos, y betalactamasas de espectro extendido, AmpC plasmídico y carbapenemasas en bacilos gram negativos. Conclusiones. El LA-EQAS es una excelente herramienta para la mejora continua de la calidad en el diagnóstico de las infecciones por microorganismos multirresistentes en los LNR de América Latina.


[RESUMO]. Objetivo. O objetivo deste trabalho é apresentar os resultados do Programa Latino-Americano de Garantia da Qualidade em Bacteriologia e Resistência Antimicrobiana (LA-EQAS, na sigla em inglês) entre 2000 e 2018 e a evolução na detecção de mecanismos de resistência com impacto clínico. Métodos. Os Laboratórios Nacionais de Referência (LNRs) participantes receberam 25 inquéritos com 10 cepas bacterianas cada, representando um total de 86 espécies bacterianas e 40 mecanismos de resistência. Para avaliar o desempenho dos LNRs, foram analisados cinco indicadores: identificação bacteriana, interpretação dos testes de sensibilidade, faixas das zonas de inibição aceitáveis, mecanismo de resistência inferido e tempo de demora na resposta. Resultados. A concordância média foi de 82,6% (intervalo: 74-95%) na identificação bacteriana, 93,3% (85-98%) na interpretação dos testes de sensibilidade, 84,6% (70-94%) nas zonas de inibição, 82,5% (73-96%) no mecanismo de resistência inferido e 34 dias na demora na resposta. Observou-se uma melhoria na detecção de mecanismos clinicamente relevantes, como a resistência a meticilina, macrolídeos e glicopeptídeos em cocos Gram-positivos, beta-lactamases de espectro ampliado, AmpC plasmídica e carbapenemases em bacilos Gram-negativos. Conclusões. O LA-EQAS é uma excelente ferramenta para a melhoria contínua da qualidade no diagnóstico de infecções por microrganismos multirresistentes nos LNRs da América Latina.


Assuntos
Anti-Infecciosos , Vigilância , Controle de Qualidade , Bacteriologia , América Latina , Anti-Infecciosos , Vigilância , Controle de Qualidade , Bacteriologia , América Latina , Anti-Infecciosos , Vigilância , Controle de Qualidade
12.
Zhongguo Yi Liao Qi Xie Za Zhi ; 44(4): 334-337, 2020 Apr 08.
Artigo em Chinês | MEDLINE | ID: mdl-32762209

RESUMO

In order to strengthen the supervision and management of medical devices, China implements pre-market registration and approval system for medical device. Technical evaluation is a key point of Chinese medical device registration management system. This study, by process-oriented, systematically sorts out the risks existing in each part of the review process. The countermeasures for risk prevention are proposed, hoping to strengthen the quality control of the whole process of review, improve the quality and efficiency of the review effectively, and ensure the various reform measures of the medical device review and approval system effectively.


Assuntos
Aprovação de Equipamentos , China , Controle de Qualidade , Medição de Risco
13.
Zhongguo Yi Liao Qi Xie Za Zhi ; 44(4): 353-358, 2020 Apr 08.
Artigo em Chinês | MEDLINE | ID: mdl-32762213

RESUMO

OBJECTIVE: Common findings are to be found from 144 different type of medical device manufacturers' audit reports which are from Jan. 2017 to Jun. 2019. Advise is to be provided for medical device manufacturers on continual improvement. METHODS: Classify and analyze the on-site audit findings from different type of medical device manufacturers. RESULTS: The frequency of findings from chapter production management, buildings and facilities, quality control are comparatively high. CONCLUSIONS: The key to improve the quality management system is to cultivate the staff sense of continual improvement of quality system, improve the staff ability of finding and solving problems, encourage staff participation in quality system, fit the quality system on product realization.


Assuntos
Indústrias , Controle de Qualidade , Fatores de Tempo
15.
Crit Rev Ther Drug Carrier Syst ; 37(3): 229-269, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32749139

RESUMO

Nanostructured drug delivery formulations have lately gained enormous attention, contributing to their systematic development. Issuance of quality by design (QbD) guidelines by ICH, FDA, and other federal agencies, in this regard, has notably influenced the overall development of drug products, enabling holistic product and process understanding. Owing to the applicability of QbD paradigms, a science lately christened as formulation by design (FbD) has been dedicated exclusively to QbD-enabled drug product development. Consisting of the principal elements of design of experiments (DoE), quality risk management (QRM), and QbD-enabled product comprehension as the fundamental tools in the implementation of FbD, a variety of drug nanocargos have been successfully developed with FbD paradigms and reported in the literature. FbD aims to produce novel and advanced systems utilizing nominal resources of development time, work effort, and money. A systematic FbD approach envisions the entire developmental path through pivotal milestones of risk assessment, factor screening and optimization (both using appropriate experimental designs), multivariate statistical and optimum search tools, along with response surface modeling, usually employing suitable computer software. The design space is one of the fundamental elements of FbD providing the most sought-after regulatory flexibility to pharma companies, postapproval. The present paper provides a bird's eye view of the fundamental aspects of FbD terminology, methodology, and applications in the development of a wide range of nanocargos, as well as a discussion of trends from both technological and regulatory perspectives.


Assuntos
Portadores de Fármacos/química , Sistemas de Liberação de Medicamentos/métodos , Desenho de Fármacos , Nanoestruturas/química , Portadores de Fármacos/administração & dosagem , Composição de Medicamentos , Humanos , Nanoestruturas/administração & dosagem , Controle de Qualidade
17.
J Hosp Infect ; 106(2): 258-263, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32745593

RESUMO

BACKGROUND: To reduce the shortage of N95 respirators and surgical masks during the COVID-19 pandemic, stockpiled equipment beyond its expiry date could be released. AIM: Centralized testing of batches of expired surgical masks and N95 for safe distribution to hospital departments saving users time. METHODS: Tests of compliance with health authority directives were developed and carried out on 175 batches of N95 masks and 31 batches of surgical masks from 12th March 2020 to 16 April 2020. Five quality-control tests were performed on batch samples to check: packaging integrity, mask appearance, breaking strength of elastic ties and strength of nose clip test, and face-fit. FINDINGS: Forty-nine per cent of FFP2 mask batches were compliant with directives, 32% of batches were compliant but with some concerns and 19% of batches were non-compliant. For surgical masks, 58% of batches were compliant, 39% of batches compliant but with concerns and 3% of batches were non-compliant. CONCLUSION: The main areas of non-compliance were the breaking strength of the elastic ties and the nose clip but these alone were not considered to make the masks unacceptable. Only mask appearance and face-fit results were decisive non-compliance criteria.


Assuntos
Infecções por Coronavirus/prevenção & controle , Fidelidade a Diretrizes , Máscaras/normas , Exposição Ocupacional/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Controle de Qualidade , Dispositivos de Proteção Respiratória/normas , Ventiladores Mecânicos/normas , Betacoronavirus , França , Humanos , Fatores de Tempo
18.
PLoS One ; 15(8): e0235171, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32797112

RESUMO

Pavement crack analysis, which deals with crack detection and crack growth detection, is a crucial task for modern Pavement Management Systems (PMS). This paper proposed a novel approach that uses historical crack data as reference for automatic pavement crack analysis. At first, a multi-scale localization method, which including GPS based coarse localization, image-level localization, and metric localization has been presented to establish image correspondences between historical and query crack images. Then historical crack pixels can be mapped onto the query crack image, and these mapped crack pixels are seen as high-quality seed points for crack analysis. Finally, crack analysis is accomplished by applying Region Growing Method (RGM) to further detect newly grown cracks. The proposed method has been tested with the actual pavement images collected in different time. The F-measure for crack growth is 88.9%, which demonstrates the proposed method has an ability to greatly simplify and enhances crack analysis result.


Assuntos
Controle de Qualidade , Imagens de Satélites/métodos , Algoritmos , Materiais de Construção/normas , Ciência dos Materiais/normas , Imagens de Satélites/normas , Transportes/normas
19.
J Cardiovasc Magn Reson ; 22(1): 60, 2020 08 20.
Artigo em Inglês | MEDLINE | ID: mdl-32814579

RESUMO

BACKGROUND: Tissue characterisation with cardiovascular magnetic resonance (CMR) parametric mapping has the potential to detect and quantify both focal and diffuse alterations in myocardial structure not assessable by late gadolinium enhancement. Native T1 mapping in particular has shown promise as a useful biomarker to support diagnostic, therapeutic and prognostic decision-making in ischaemic and non-ischaemic cardiomyopathies. METHODS: Convolutional neural networks (CNNs) with Bayesian inference are a category of artificial neural networks which model the uncertainty of the network output. This study presents an automated framework for tissue characterisation from native shortened modified Look-Locker inversion recovery ShMOLLI T1 mapping at 1.5 T using a Probabilistic Hierarchical Segmentation (PHiSeg) network (PHCUMIS 119-127, 2019). In addition, we use the uncertainty information provided by the PHiSeg network in a novel automated quality control (QC) step to identify uncertain T1 values. The PHiSeg network and QC were validated against manual analysis on a cohort of the UK Biobank containing healthy subjects and chronic cardiomyopathy patients (N=100 for the PHiSeg network and N=700 for the QC). We used the proposed method to obtain reference T1 ranges for the left ventricular (LV) myocardium in healthy subjects as well as common clinical cardiac conditions. RESULTS: T1 values computed from automatic and manual segmentations were highly correlated (r=0.97). Bland-Altman analysis showed good agreement between the automated and manual measurements. The average Dice metric was 0.84 for the LV myocardium. The sensitivity of detection of erroneous outputs was 91%. Finally, T1 values were automatically derived from 11,882 CMR exams from the UK Biobank. For the healthy cohort, the mean (SD) corrected T1 values were 926.61 (45.26), 934.39 (43.25) and 927.56 (50.36) for global, interventricular septum and free-wall respectively. CONCLUSIONS: The proposed pipeline allows for automatic analysis of myocardial native T1 mapping and includes a QC process to detect potentially erroneous results. T1 reference values were presented for healthy subjects and common clinical cardiac conditions from the largest cohort to date using T1-mapping images.


Assuntos
Cardiomiopatias/diagnóstico por imagem , Interpretação de Imagem Assistida por Computador , Imagem por Ressonância Magnética , Miocárdio/patologia , Redes Neurais de Computação , Automação , Teorema de Bayes , Cardiomiopatias/patologia , Cardiomiopatias/fisiopatologia , Estudos de Casos e Controles , Humanos , Valor Preditivo dos Testes , Controle de Qualidade , Reprodutibilidade dos Testes , Volume Sistólico , Incerteza , Função Ventricular Esquerda
20.
J Chromatogr A ; 1627: 461430, 2020 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-32823119

RESUMO

There is a huge, still increasing market for synthetic and therapeutic peptides. Their quality control is commonly based on a generic reversed-phase liquid chromatography (RPLC) method with C18 stationary phase and acetonitrile gradient with 0.1% trifluoroacetic acid in the mobile phase. It performs exceptionally well for a wide variety of impurities, yet structurally closely related impurities with similar sequences, not resolved in preparative RPLC, may easily coelute in the corresponding QC run as well. To address this problem an advanced generic 2D-LC impurity profiling method was developed in this work. It employs a selective comprehensive (high resolution sampling) RP×RP 2D-LC separation using a 100×2.1 mm ID column with the common acidic generic gradient in the first dimension, while RPLC under basic pH on a short 30×3 mm ID column is used in the second dimension. Recording data with a UV detector at 215 nm after 1D separation provides the common generic 1D chromatogram. However, after the 2D separation a flow splitter enabled recording of the signals of complementary detectors comprising a diode array detector (DAD) in-line with a charged aerosol detector (CAD) and a quadrupole-time-of-flight (QTOF) mass spectrometer (MS) with an electrospray ionization (ESI) source. Generic conditions of this 2D-LC method have been established through optimization of 2D stationary and mobile phase considering different pH values and buffer concentrations. The orthogonal separation principle has been documented by a number of therapeutic peptides including Exenatide, Octreotide, Cyclosporine A and Oxytocin as well as some other proprietary synthetic peptides. The information density can be further enhanced by using the QTOF-MS detector by data independent acquisition with SWATH. Through this sequential window acquisition of all theoretical fragment ion mass spectra it became possible to collect MS/MS data comprehensively in the high-resolution sampling window, thus enabling the extraction of 2D-EICs from fragment ions and the generation of 2D-contour plots of all product ions. Using Oxytocin as an example for an important therapeutic peptide, the ability of this advanced generic sRP-UV×RP-DAD-CAD-ESI-QTOF-MS/MS method with SWATH for peptide quality control is discussed.


Assuntos
Cromatografia Líquida de Alta Pressão/métodos , Cromatografia de Fase Reversa/métodos , Peptídeos/análise , Acetonitrilos/química , Tampões (Química) , Concentração de Íons de Hidrogênio , Ocitocina/análise , Controle de Qualidade , Solventes/química , Espectrometria de Massas em Tandem
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