Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 20 de 81
Article in Chinese | WPRIM | ID: wpr-928912


In the perspective of technical evaluation, the pre-marketing regulatory requirements of allergen detection reagents in China, America, European Union were compared, and the regulatory risks and performance requirements of this product were analyzed based on the monitoring of post-marketing adverse events, reference standards and domestic and foreign regulatory documents. In view of the "neck-stuck" problems such as the difficulty of clinical trials, the difficulty of finding comparable contrast reagents and the lack of clinical diagnostic gold standards, this paper discusses and gives regulatory suggestions, with a view to providing technical reference for product R&D, production, evaluation, approval and supervision in this field.

Allergens , European Union , Indicators and Reagents , Marketing , Reference Standards
Med. lab ; 26(2): 159-175, 2022. tab
Article in Spanish | LILACS | ID: biblio-1393231


Las mediciones confiables, trazables metrológicamente y comparables proporcionan la base racional para la evaluación de la calidad de un resultado y el fortalecimiento de las redes de laboratorios clínicos, lo cual permite mejorar la calidad de atención y la seguridad del paciente. En este documento se revisan los principios básicos que deben seguirse para garantizar la trazabilidad de las mediciones del laboratorio clínico, las ventajas de utilizar métodos trazables, el impacto de no hacerlo, y se discuten las principales limitaciones para relacionar las mediciones con los estándares de medición de referencia apropiados

Reliable, metrologically traceable, and comparable measurements provide the rationale for evaluating the quality of a result and strengthening clinical laboratory networks, thereby improving quality of care and patient safety. This document reviews the basic principles that must be followed to ensure the traceability of clinical laboratory results, the advantages of using traceable methods, the impact of not doing so, and the main limitations in relating measurements to appropriate reference standards

Data Accuracy , Reagent Kits, Diagnostic , Reference Standards , Calibration , Equipment and Supplies , International System of Units
rev. udca actual. divulg. cient ; 24(2): e1689, jul.-dic. 2021. graf
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1361226


RESUMEN La semilla es el insumo principal para el establecimiento de sistemas productivos agrícolas, por lo cual, durante la producción de semilla, una condición indispensable es que se mantenga la calidad del material en todo el proceso incremental. El Departamento de Semillas de la Corporación Colombiana de Investigación Agropecuaria-Agrosavia, comprometido con el cumplimiento de los requisitos establecidos en la Resolución ICA 3168 de 2015 y en el Decreto del MADR 931 de 2018, en todos sus procesos productivos, ha desarrollado e implementado un Sistema Interno de Trazabilidad (SIT) para la producción de semilla y, específicamente, en una de sus estrategias denominada Plan de Mínimos para cultivos semestrales soya, algodón, arroz, maíz y sorgo en los valles interandinos. Los resultados mostraron que esta herramienta tecnológica facilitó, en el proyecto, realizar el monitoreo y el seguimiento de las labores, el registro de eventos climáticos, el manejo eficiente de inventarios y el análisis de costos. Esta reflexión es un trabajo pionero en Colombia, que contribuye a la toma de decisiones, a mejorar la productividad y a fortalecer el Sistema Nacional de Semillas.

ABSTRACT Seed is the main input for the establishment of agricultural production systems, so during seed production an indispensable condition is that the quality of the material is maintained throughout the incremental process. The Seed Department of Colombian Agricultural Research Corporation- Agrosavia, committed to complying with the requirements established in Resolution ICA 3168 of 2015 and Decree MADR 931 of 2018in all its production processes, has developed and implemented an Internal Traceability System (SIT) for the production of seed and specifically in one of its strategies called Minimum Plan for semi-annual crops of soybean, cotton, rice, corn and sorghum in the inter-Andean valleys. The results show that this technological tool facilitated in the project carried out the monitoring and tracing of the crops work, the registry of climatic events, the efficient management of inventories and the analysis of costs. This is a pioneering work in Colombia, which contributes to decision making, improve productivity and strengthen the National Seed System.

Article in Chinese | WPRIM | ID: wpr-888129


The development of quality Chinese medicine is an important way to improve the quality of Chinese medicine, and ensure the safety and effectiveness of Chinese medicine. This article systematically elaborates the definition, classification, standard and mana-gement certification strategy of quality Chinese medicine. We present the quality Chinese medicine which is higher quality than that of eligible Chinese medicine based on quality control standards. Quality Chinese medicine is strictly in accordance with management procedures, likely GAP and GMP et al, during the productive process, which quality indicators is higher than that of the current relevant national quality standards, such as Chinese Pharmacopoeia(ChP) et al; its limited indicators such as exogenous pollutants and endogenous toxic substances are lower than that of the current relevant national quality standards, likely ChP et al; meanwhile these Chinese herbal medicine, medicinal pieces, patent medicines, and health products and foods with Chinese medicine raw materials are been certificated by quality Chinese medicine. At the same time, this article systematically expounds the five major management systems of quality Chinese medicine, including technical training management for practitioners, productive process management, standard mana-gement, quality inspection and certification management, and product traceability management. And we put forward strategies to improve the supervision and management system, and promote the standardization and development of quality Chinese medicine by improving the technical management system of quality Chinese medicine, strengthening the quality management system and six sigma(6σ) management in the company. These strategies will provide a reliable basis and effective way to improve the quality of Chinese medicine.

Drugs, Chinese Herbal , Food , Medicine, Chinese Traditional , Quality Control , Reference Standards
Article in Chinese | WPRIM | ID: wpr-880454


In this paper, some significant problems, which were found frequently in the products of autoimmune

Indicators and Reagents
Article in Chinese | WPRIM | ID: wpr-880445


Focusing on the requirements of visual traceability for reprocessing of reused medical devices under the background of deep integration of intelligent medical treatment, a quality and safety traceability system for disinfection of reused medical devices is developed. The multi-dimensional data of the reprocessing chain of reusable medical devices are acquired in real time by the RFID mobile terminal handset and stored temporarily. The data package is formatted based on LoRa protocol and uploaded to the management and control platform in multi-threaded transmission mode for in-depth analysis and traceability. The corresponding prototype system is developed. The first-line operation and maintenance test results show that the prototype system has strong cooperation, strong operation robustness, and obvious advantages in the identification rate and other layers of sterile equipment package.

Disinfection , Radio Frequency Identification Device , Technology
Article in Chinese | WPRIM | ID: wpr-878879


This paper established the identification technology of the main root origin of three-year-old spring Panax notoginseng aiming at providing theoretical basis for the protection and traceability of geographical indication products of P. notoginseng. Forty-four samples of three-year-old spring P. notoginseng from Guangxi Baise, Yunnan Wenshan, Yunnan new cultivating regions. The stable isotopic ratios of carbon, nitrogen, hydrogen and oxygen were determined by elemental analysis and stable isotope mass spectrometer. Combined with Duncan multiple comparative analysis, fisher discriminant analysis and sequential discriminant analysis, a origin discriminant model for the main root of three-year-old spring P. notoginseng was established for 3 production areas of P. notoginseng. The geographical climate and environment of three production areas of P. notoginseng are obviously different. From Guangxi Baise-Yunnan Wenshan-Yunnan new cultivating regions, the longitude, average annual temperature and annual precipitation gradually decrease, and the elevation and latitude are increasing. The results of multiple comparative analysis showed that there were significant or very signi-ficant differences in the δ~(13)C,δ~(15)N,δ~2H,δ~(18)O of the main roots of P. notoginseng in three regions. The results of fisher's discriminant analysis and sequential discriminant analysis showed that the correct discriminant rates of the main roots of P. notoginseng for three regions were 80.05%,76.47% and 90.91%, respectively, based on four stable isotope ratios, with an average of 84.09%. Using stable isotope fingerprint and chemometrics method, we can distinguish the origin of the main raw materials and products of P. notoginseng.

China , Geography , Isotopes , Panax notoginseng , Seasons
Article in Chinese | WPRIM | ID: wpr-906004


As a Chinese saying goes, "good Chinese medicinal material makes good medicine", the traceability of Chinese medicinal materials is closely related to the high-quality development of Chinese medicine industry. This article intends to analyze the "new era of smarter food safety blueprint" and Proposed Rule for Food Traceability related to food traceability of the U.S. Food and Drug Administration (FDA), including food traceability list, critical tracking events, and examples of exemptions. By studying the process and consideration of the construction of the FDA food traceability system, as well as the specific traceability requirements of fresh herbs, vegetables and fruits in the FDA food traceability system that are related to Chinese medicinal materials, on the one hand, it provides research materials for the communication and discussion of Chinese medicinal materials traceability, on the other hand, it also provides reference for the construction of food traceability system in China. To sort out the idea of constructing a traceability system for Chinese medicinal materials suitable for the current development status of traditional Chinese medicine, the contents to be considered are as follows:①To determine the traceability list of Chinese medicinal materials based on the risk control of Chinese medicinal materials. ②Determine the critical tracking links and information in the Chinese medicinal materials industry chain, and standardize the traceability information of Chinese medicinal materials. ③The quality information of Chinese medicinal materials should be reflected in the traceability of Chinese medicinal materials. ④Within the scope of the traceability list of Chinese medicinal materials, enterprises should be encouraged to make voluntary traceability by selecting Chinese medicinal materials with a good foundation of traceability work.

Article in Chinese | WPRIM | ID: wpr-922044


Aiming at the shortcomings of traditional medical device tracking and supervision mode, such as delayed feedback of medical device positioning information, poor visual tracking effect of medical device, and missing early warning of medical device working state supervision, a medical device visual tracking and supervision system based on wireless Local Area Network (LAN) real-time positioning system is developed. Introduction of wireless LAN real-time positioning system, using standard coding algorithm generating device object ID tags, with the only attribute based on RFID read-write terminal complete physical mapping of medical equipment and material ID label, we realize a real-time positioning and traceability of medical equipment, with the help of active warning algorithm based on depth of learning medical equipment working state supervision for early warning, with the help of indoor map generation and trajectory playback medical equipment to realize visualization back regulation. Choose equipment of hospital of Linyi Central Hospital for performance evaluation of the carrier, the evaluation model of engineering practice and clinical statistical analysis, the results show that the system has a complete real-time positioning, visible trace, abnormal warning function. In medical equipment real-time positioning information visual tracing feedback, abnormal state warning etc, medical equipment has obvious advantages.

Algorithms , Local Area Networks
Article in Chinese | WPRIM | ID: wpr-865656


Emblic medicine is a popular natural source in the world due to its outstanding healthcare and therapeutic functions. Our preliminary results indicated that the quality of emblic medicines might have an apparent regional variation. A rapid and effective geographical traceability system has not been designed yet. To trace the geographical origins so that their quality can be controlled, an integrated spectroscopic strategy including spectral pretreatment, outlier diagnosis, feature selection, data fusion, and machine learning algorithm was proposed. A featured data matrix (245 × 220) was successfully generated, and a carefully adjusted RF machine learning algorithm was utilized to develop the geographical traceability model. The results demonstrate that the proposed strategy is effective and can be generalized. Sensitivity (SEN), specificity (SPE) and accuracy (ACC) of 97.65%, 99.85% and 97.63% for the calibrated set, as well as 100.00% predictive efficiency, were obtained using this spectroscopic analysis strategy. Our study has created an integrated analysis process for multiple spectral data, which can achieve a rapid, nondestructive and green quality detection for emblic medicines originating from seventeen geographical origins.

Acta Pharmaceutica Sinica ; (12): 1784-1791, 2020.
Article in Chinese | WPRIM | ID: wpr-825174


DNA barcoding technology, a method of identifying biological species through a standard sequence, is widely used in the identification of traditional Chinese medicine (TCM), promoting the renaissance of TCM authentication discipline. The whole industrial chain of TCM includes three sections: the planting and collecting in the upstream chain, the production of TCM in the midstream chain and the circulation in the downstream chain. DNA barcoding technology, which possesses accurate, common, and objective advantages, plays an important role in the whole industrial chain of TCM. In the upstream, it is used to identify the seeds, seedlings and medicinal plants, ensuring the original source is correct. In the middle, it is used to identify Chinese medicinal materials, Chinese herbal slices and Chinese patent medicines, ensuring the materials of enterprises are correct and the clinical medication is safe. In the downstream, it participates in the establishment of traceability system for TCM, achieving the recording, inquiry and traceability of information. Therefore, DNA barcoding technology should help to control the whole production process, to protect the rights and interests of consumers and contribute to the supervision of TCM. Combined with some study cases in recent years, this paper introduces the application of DNA barcoding technology in the whole industrial chain of TCM, which is of great significance to promote the modernization of TCM industry and their internationalization.

Article in Chinese | WPRIM | ID: wpr-878816


It is crucial to establish a complete set of traditional Chinese medicine(TCM) quality traceability management process system, in order to stabilize the pricing order of TCM market and reconstruct the transmission path of TCM quality signals. In this study, we reviewed the mature experience of food and drug supervision at home and abroad, analyzed the quality characteristics of TCM, and put forward that the quality control of TCM products can learn from the hazard analysis and critical control point(HACCP) system in food safety quality control. This study points out that the HACCP system provides not only technical guidance for the traceability management of TCM, but also ideas for improving the quality of TCM products and the safety risk control of TCM. The application of the HACCP system in TCM quality control can help establish an international dialogue platform for TCM and help realize the modernization and internationalization of TCM industry.

Biological Products , Drugs, Chinese Herbal , Hazard Analysis and Critical Control Points , Medicine, Chinese Traditional , Quality Control
Acta bioquím. clín. latinoam ; 53(4): 487-497, dic. 2019. ilus, graf, tab
Article in English | LILACS-Express | LILACS | ID: biblio-1124026


Equivalence of results among laboratories is a major mission for medical laboratories. In the Netherlands, medical laboratories only use homogenous, commercial for general chemistry analytes, whereas in Argentina heterogenous, home brew test applications are common. The effect of this practice difference on test accuracy is studied using key features of the accuracy-based EQA program of the Netherlands. Six frozen, human-based, commutable poolsera, covering the (patho) physiological measuring range for 17 general chemistry analytes, were assayed by ~75 Argentinian labs and ~200 Dutch laboratories in 2014. After removal of outliers, harmonization status among laboratories was evaluated by calculating overall mean interlaboratory coefficients of variation (CVs, %) per analyte and per country for all 6 levels. Evenso, standardization status was evaluated after removal of outliers by calculating overall mean recoveries (%) as compared to the assigned target values per analyte per country for all 6 levels. Absolute median biases were compared to (minimal/desirable) biases derived from biological variation criteria. For serum enzymes interlaboratory CVs in the Argentinian laboratories ranged between 10 and 22%, as compared to 3-6% in the Netherlands. For serum uric acid, creatinine, glucose and total protein, interlaboratory CVs varied between 4.3 and 13.1% in Argentinian labs, as compared to <3.5% in the Netherlands. For serum electrolytes, interlaboratory CVs ranged between 1.8 and 3.8% for Na+; 2.9-5.8% for Cl-; 3.8-7.5% for K+; 9.4-10.4% for Ca2+ and 16.2-22.3% for Mg2+ as compared to ≤2% (Na+, K+, Cl-, Ca2+) and ≤3% (Mg2+) in the Netherlands. Mean recoveries in Argentinian laboratories for e.g. serum creatinine, glucose, CK, Ca2+ and Na+ were 95-119%; 95-104%; 98-102%; 98-102% and 96-100% respectively, whereas min-max recovery ranges were 65-155%; 58-126%; 47-132%; 66-132% and 85-115%. In the Netherlands, absolute mean recoveries were overall 98.9% with a SD of 2.0%. Median biases in Argentinian laboratories ranged from -2.9 to 18.2%; -3.1 - 2.6%; -3.3 - 0.5%; -1.1 - 3.8% and -4.3-0% for serum creatinine, glucose, CK, Ca2+ and Na+. In the Netherlands overall mean/median biases were 1.1% (SD=2.0%). Exchange of commutable, value- assigned EQA-materials was helpful for studying the harmonization and standardization status of medical tests in Argentina, and for revealing the future harmonization and standardization potential. The results clearly demonstrate that metrological traceability of test results in Argentina is on average in line with what is expected; yet, the spreading among laboratories is far too high and should be improved.

La equivalencia de resultados entre laboratorios es una mision importante para los laboratorios medicos. En los Paises Bajos, los laboratorios medicos solo usan aplicaciones comerciales homogeneas, regulatoriamente aprobadas (CE-IVD) para analitos quimicos, mientras que en la Argentina son comunes las aplicaciones heterogeneas caseras. El efecto de esta diferencia practica en la precision de la prueba se estudia utilizando caracteristicas clave del programa EQA, basado en la precision, de los Paises Bajos. Se ensayaron seis pools de sueros, congelados, de origen humano, conmutables, que cubrian el rango de medidas (pato)fisiologicas para 17 analitos de quimica clinica. Estos analitos de quimica clinica fueron analizados por ~75 laboratorios argentinos y ~200 laboratorios holandeses en 2014. Despues de eliminar los valores atipicos, el estado de armonizacion entre los laboratorios fue evaluado calculando los coeficientes de variacion interlaboratorios medios globales (CV%) por analito y por pais para los 6 niveles. No obstante, el estado de estandarizacion se evaluo despues de la eliminacion de valores atipicos mediante el calculo de recuperaciones medias generales (%) en comparacion con los valores asignados por analito por pais para los 6 niveles. Los sesgos medios absolutos se compararon con los sesgos (minimos / deseables) derivados de los criterios de variacion biologica. Para enzimas sericas los CV interlaboratorio en los laboratorios argentinos oscilaron entre 10 y 22%, en comparacion con 3-6% en los Paises Bajos. Para el acido urico serico, creatinina, glucosa y proteinas totales, los CV entre laboratorios variaron entre 4,3 y 13,1% en los laboratorios argentinos, en comparacion con <3,5% en los Paises Bajos. Para los electrolitos sericos, los CV interlaboratorios oscilaron entre 1,8 y 3,8% para Na+; 2,9-5,8% para Cl-; 3,8-7,5% para K+; 9,4-10,4% para Ca2+ y 16,2-22,3% para Mg2+ en comparacion a ≤2% (Na+, K+, Cl-, Ca2+) y ≤3% (Mg2+) en los Paises Bajos. Las recuperaciones medias en laboratorios argentinos para, p.ej. la creatinina serica, glucosa, CK, Ca2+ y Na+ fueron 95-119%; 95-104%; 98-102%; 98-102% y 96-100% respectivamente, mientras que los rangos de recuperacion min-max fueron 65-155%; 58-126%; 47-132%; 66-132% y 85-115%. En los Paises Bajos, las recuperaciones medias absolutas fueron en general del 98,9% con una desviacion estandar (DE) del 2,0%. La mediana de los sesgos medios de los laboratorios argentinos oscilo entre -2,9 y 18,2%; -3,1 - 2,6%; -3,3 - 0,5%; -1,1 - 3,8% y -4,3-0% para creatinina serica, glucosa, CK, Ca2+ y Na+. En los Paises Bajos, las medias / medianas en general fueron de 1,1% (DE=2,0%). El intercambio de los valores asignados a los materiales EQA, conmutables fue de gran ayuda para la armonizacion y estandarizacion de los ensayos medicos en la Argentina y para revelar el potencial futuro de armonizacion y estandarizacion. Estos resultados claramente demuestran que la trazabilidad metrologica de los resultados de las pruebas en la Argentina esta, en promedio, de acuerdo con lo esperable; sin embargo, la dispersion entre laboratorios es muy grande y deberia ser mejorada.

A equivalencia de resultados entre laboratorios e uma missao importante para os laboratorios medicos. Nos Paises Baixos, os laboratorios medicos so utilizam aplicacoes comerciais homogeneas, aprovadas por regulacoes (CE-IVD) para analitos quimicos, ao passo que na Argentina sao comuns as aplicacoes heterogeneas caseiras. O efeito desta diferenca pratica na exatidao do teste e estudado utilizando caracteristicas essenciais do programa EQA, dos Paises Baixos, baseado na exatidao. Foram ensaiados seis pools de soros, congelados, de origem humana, comutaveis, que abrangiam a faixa de medidas (pato)fisiologicas para 17 analitos quimicos gerais. Esses analitos quimicos foram analisados por ~75 laboratorios argentinos e ~200 laboratorios holandeses em 2014. Apos eliminar os valores atipicos, o estado de harmonizacao entre os laboratorios foi avaliado atraves do calculo dos coeficientes de variacao interlaboratorio meios globais (CV%) por analito e por pais para os 6 niveis. Nao obstante, o estado de padronizacao foi avaliado depois da eliminacao de valores atipicos pelo calculo de recuperacoes medias gerais (%) se comparados com os valores atribuidos por analito por pais para os 6 niveis. Os vieses medios absolutos foram comparados com os vieses (minimos / desejaveis) decorrentes dos criterios de variacao biologica. Para enzimas sericas, os CV interlaboratorio nos laboratorios argentinos oscilaram entre 10 e 22%, em comparacao com 3-6% nos Paises Baixos. Para o acido urico serico, creatinina, glicose e proteinas totais, os CV entre laboratorios variaram entre 4,3 e 13,1% nos laboratorios argentinos, em comparacao com <3,5% nos Paises Baixos para os eletrolitos sericos, os CV interlaboratorios oscilaram entre 1,8 e 3,8% para Na+; 2,9-5,8% para Cl-; 3,8-7,5% para K+; 9,4-10,4% para Ca2+ e 16,2-22,3% para Mg2+ em comparacao com ≤2% (Na+, K+, Cl-, Ca2+) e ≤3% (Mg2+) nos Paises Baixos. As recuperacoes medias em laboratorios argentinos para, p.ex. a creatinina serica, glicose, CK, Ca2+ e Na+ foram 95-119%; 95-104%; 98-102%; 98-102% e 96-100% respectivamente, enquanto que os intervalos de recuperacao min-max. foram 65-155%; 58-126%; 47-132%; 66-132% e 85-115%. Nos Paises Baixos, as recuperacoes medias absolutas foram em geral de 98,9% com um desvio padrao (DE) de 2,0%. A mediana dos vieses medios dos laboratorios argentinos oscilou entre -2,9 e 18,2%; -3,1 - 2,6%; -3,3 - 0,5%; -1,1 - 3,8% e -4,3-0% para creatinina serica, glicose, CK, Ca2+ e Na+. Nos Paises Baixos, as medias / medianas em geral foram de 1,1% (DE=2,0%). O intercambio dos valores atribuidos aos materiais EQA, comutaveis, foi de grande ajuda para a harmonizacao e padronizacao dos ensaios medicos na Argentina e para revelar o potencial futuro de harmonizacao e padronizacao. Esses resultados demonstram as claras que a rastreabilidade metrologica dos resultados dos testes na Argentina esta de acordo com o esperavel; a dispersao entre laboratorios ainda e muito grande e deveria ser melhorada.

Humans , Reference Standards , Clinical Chemistry Tests , Clinical Chemistry Tests/methods , Laboratories , Physicians , Uric Acid , Weights and Measures , Proteins , Bias , Chemistry, Clinical , Creatinine , State , Electrolytes , Enzymes , Methodology as a Subject , Glucose
Rev. colomb. quím. (Bogotá) ; 48(3): 36-44, sep.-dic. 2019. tab, graf
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1058426


Resumen La producción de un material de referencia (MR) es un proceso en el que se realizan estudios relacionados con la preparación, envasado y caracterización (incluye homogeneidad y estabilidad). En este trabajo se presentan los resultados del desarrollo de un MR de agua potable. El envasado se realiza aplicando dos procedimientos (envasado convencional e inmersión). La caracterización se realizó por Absorción Atómica, ICPMS y Cromatografía iónica. La evaluación de homogeneidad del material se realizó para Na, Mg, Ca, Fe, K, Co, Pb, Mo, As, Ni, Se, Cu, Al, Cr Zn y aniones como NO3 - y Cl-. La estabilidad se evaluó a corto (condiciones aceleradas) y largo plazo por ICPMS y CI, además se realizó seguimiento gravimétrico. La homogeneidad y estabilidad se evaluaron con base en su incertidumbre. La incertidumbre asociada a la homogeneidad y estabilidad MR evidenció resultados aceptables para la mayoría de los analitos. Los resultados del seguimiento gravimétrico permitieron detectar pérdidas de masa del material, por lo que se planteó un nuevo esquema para evaluar la estabilidad a través de métodos gravimétricos. Finalmente, se encontró que el MR presenta incertidumbres expandidas entre el 0,93% y el 4,38%, siendo apto para el uso previsto.

Abstract The production of reference materials (RM) is a process that involves carrying out different studies related to the preparation, packaging and chemical stability of the analytes. This paper presents the results of the development of a drinking water RM. The packaging is done by applying two procedures (conventional packaging and immersion). The characterization of this material was carried out through atomic absorption, ICPMS and ion chromatography. The assessment of the homogeneity of the material was carried out for Na, Mg, Ca, Fe, K, Co, Pb, Mo, As, Ni, Se, Cu, Al, Cr Zn and anions as NO3 - y Cl-. The stability studies were evaluated in the short term (accelerated conditions), and long term by ICPMS and IC, and gravimetric monitoring was also performed. Homogeneity and stability were evaluated based on their uncertainty. The uncertainty associated with homogeneity and MR stability evidenced acceptable results for most analytes. The results of the gravimetric monitoring allowed to detect losses of mass of the material, reason why a new scheme was proposed to evaluate the stability through gravimetric methods. Finally, it was found that the RM presents expanded uncertainties between 0,93% and 4,38%, which makes it suitable for the intended use.

Resumo Este artigo apresenta os resultados do desenvolvimento de um MR de água potável. A embalagem é feita aplicando dois procedimentos (embalagem convencional e imersão). A caracterização foi realizada por Absorção Atômica, ICPMS e Cromatografia Iônica. A avaliação da homogeneidade do material foi realizada para Na, Mg, Ca, Fe, K, Co, Pb, Mo, As, Ni, Se, Cu, Al, Cr Zn e ânions como NO3 - y Cl-. A estabilidade foi avaliada em curto prazo (condições aceleradas) e em longo prazo pelo ICPMS e IC, e também foi realizada monitoração gravimétrica. A homogeneidade e estabilidade foram avaliadas com base na incerteza. A incerteza associada à homogeneidade e estabilidade da RM evidenciou resultados aceitáveis para a maioria dos analitos. Os resultados do monitoramento gravimétrico permitiram detectar perdas de massa do material, pelo que foi proposto um novo esquema para avaliar a estabilidade por métodos gravimétricos. Por fim, verificou-se que o RM apresenta incertezas expandidas entre 0,93% e 4,38%, sendo adequado para o uso pretendido.

China Pharmacy ; (12): 3025-3029, 2019.
Article in Chinese | WPRIM | ID: wpr-817435


OBJECTIVE: To provide reference for the improvement of drug information traceability system in China. METHODS: Using “drug information traceability”“drug traceability”“electronic drug supervision” as keywords, related literatures,relevant laws and regulations about drug information traceability were retrieved from PubMed, CNKI, Wanfang database, VIP, Drug Supervision Department or Health Administration websites of USA, EU and China from Jan. 2014 to Apr. 2019. Compared with USA and EU, the problems of drug information traceability system in China were analyzed to put forward the countermeasures and suggestions. RESULTS & CONCLUSIONS:A total of 31 literatures were included. The drug information traceability system was established in USA, EU and China. USA and EU have the advantages of coding to be in line with international standards, making full use of third-party platforms to avoid forming monopoly, etc. Drug information traceability system was still in a crucial stage of improvement in China. There were still many problems, such as more specific operating standards and guidelines are needed, too many supply chain participants, uneven information level, drug information traceability system independent of the transaction, reimbursement and other information systems, and insufficient coordination. It is suggested to improve the relevant laws and regulations on drug information traceability system by drug supervision department as soon as possible, and give full play to the role of third-party platform, and establish drug information traceability platform based on drug trading platform so as to ensure the system to play an important role in deepening the reform of medical and health system, ensuring the supply of shortage drugs, promoting rational drug use and comprehensive supervision.

Article in Chinese | WPRIM | ID: wpr-801121


Chronic kidney disease caused by diabetes and hypertension has become a global public health problem. Urinary albumin is one of the key indicators for the diagnosis and grading of chronic kidney disease, and it has been widely used in practice. Accurate and comparable results of urinary albumin detection served as an important basis for clinical application. This paper discussed the status of urinary albumin detection and the progress of standardization, in order to help the laboratory correctly interpret the test results and promote the quality of diagnostic products.

Article in Chinese | WPRIM | ID: wpr-773744


The quality marker( Q-maker) of traditional Chinese medicine( TCM) has been the core concept of TCM quality evaluation and control in recent years. Based on the knowledge and long-term practice of the researches on TCM quality,we put forward that " Taking the effectiveness as the core,the measurability and peculiarity as necessary conditions,and considering compatibility for TCM formulae,TCM Q-makers are selected and confirmed,and then the transmission and traceability should be investigated as its functional attributes". Selecting the commonly used representative TCM as the research object,based on the score of TCM effectiveness,measurability and peculiarity,a layered three-dimensional integrated technology was adopted for the quantitative evaluation and grading identification of the Q-markers for TCM. And after Q-markers for TCM are selected and confirmed,the transmission variation of the Q-markers is studied in the whole process from the formation of TCM to its function representation. Based on TCM chemical and biological characteristics as well as effectiveness,and integrating multidisciplinary techniques and methods,researches on innovative methods for system identification and confirmation of the TCM Q-makers are developed emphatically to form representative and exemplary extensive application,which will provide significant theoretical and methodological support for effectively improving the quality control level of TCM.

Biomarkers , Drugs, Chinese Herbal , Reference Standards , Medicine, Chinese Traditional , Reference Standards , Quality Control
Article in Chinese | WPRIM | ID: wpr-746321


Objective To acquire specific suggestions for improving the transparency of clinical research.Methods Summarize main challenges for transparency in clinical research,propose possible solutions.Results Currently the common practice of clinical research transparency is to promote study registration in the beginning phase,and reporting guildlines,data sharing in the end phase of the study.The main challenges identified in clinical research transparency are (1) lacking awareness of transparency among investigators,(2) poor data integrity and traceability of research data resulted by the ignorance of transparency during study implementation process.To face the challenges,investigator should be more proactive and related research administration should be streamlined.Conclusions To improve the transparency of clinical research,better understandings of the concept of clinical research transparency for investigators and whole-process supervision from the administrative aspect should be strengthened.Furthermore,advanced information technology should be adopted to construct a hospital-based source data platform for complete clinical research process management,it helps in promoting research data quality and could become a suitable tool for clinical research administration in hospitals.Ultimately,full research transparency would be achieved.

rev. udca actual. divulg. cient ; 21(2): 467-477, jul.-dic. 2018. tab, graf
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1094749


RESUMEN La trazabilidad es un factor importante para garantizar la calidad de los alimentos que llegan a los consumidores; sin embargo, tiene implicaciones operativas que deben ser abordadas. En este artículo, se desarrolla una metodología que considera un modelo matemático de programación no lineal entera mixta, el cual, atiende las implicaciones productivas y los costos asociados con la trazabilidad, incorporando el costo potencial de retirar productos del mercado, como principal componente de la trazabilidad, en el cálculo del tamaño de lote. Los aportes centrales del modelo son la consideración de la lista de materiales del producto y la consideración de diferentes lotes de materia prima, con niveles de riesgo y costos diferentes. Con esta investigación, se logró identificar que la variabilidad en los parámetros de capacidad y de riesgo de los lotes de la materia prima impactan en el costo potencial de retirar productos del mercado y, por ende, en la definición del tamaño de lote de producción.

ABSTRACT Traceability is an important factor to confirm the quality of the food that reaches users, however, it has operational implications that must be addressed. this article develop a methodology based on mixed-integer nonlinear programming, which address the productive implications and costs associated with traceability, incorporating the potential cost of with-drawing the products from the market as a main component of traceability in the definition of the production lot size. The main contributions of the model are the consideration of the list of the materials of the product and the batches of the raw material with different levels of risk and costs. this research allowed to identify the capacity and risk parameters of the batches of raw material that impact on the potential cost of withdrawing products from the market and, therefore, in the definition of the production lot size.

Acta bioquím. clín. latinoam ; 52(2): 185-193, jun. 2018. graf, tab
Article in Spanish | LILACS | ID: biblio-949332


El objetivo del trabajo consistió en evaluar, en una muestra de estudiantes, las consecuencias sobre la Tasa de Filtración Glomerular estimada (TFGe) por MDRD-4, MDRD-4 IDMS y CKD-EPI producidas por la selección inadecuada de las fórmulas según la trazabilidad de la creatininemia utilizada y valorar el efecto sobre la categorización por estadio G de TFG al utilizar valores numéricos de MDRD-4 y MDRD-4 IDMS≥60 mL/min/1,73 m². Se realizó un estudio descriptivo, analítico, de corte transversal con 100 alumnos de bioquímica, que participaron voluntariamente. Se determinó la creatininemia por métodos Jaffé cinéticos, valores trazables y no trazables al Isotopic Dilution Mass Spectroscopy (IDMS). La TFGe se calculó por las fórmulas MDRD-4, MDRD-4 IDMS y CKD-EPI introduciendo en cada fórmula valores de creatinina trazables y no trazables a IDMS. Los estudiantes se clasificaron por categoría G según los resultados. El mal empleo de las ecuaciones respecto a la trazabilidad de la creatininemia según fueron diseñadas cambió sensiblemente los valores de TFGe (p<0,05) y la proporción de jóvenes por estadio G respecto a lo hallado con el empleo adecuado (MDRD-4. G1: 67,4% vs. 53,7%; G2: 32,6% vs. 45,3%; G3a: 0,0% vs. 1,0%. MDRD-4 IDMS. G1: 37,9% vs. 59,0%; G2: 56,8% vs. 40,0%; G3a: 5,3% vs. 1,0%. CKD-EPI. G1: 70,5% vs. 85,3%; G2: 29,5% vs. 14,7%). El uso de valores numéricos para TFGe por MDRD-4 y MDRD-4 IDMS≥60 mL/min/1,73 m² infraestimó lo obtenido con CKD-EPI, que puede informarse numéricamente en ese rango. Ambas situaciones conllevan errores que afectan la categorización funcional renal de pacientes y la prevalencia en estudios epidemiológicos.

The objective of this work was to evaluate the consequences on the estimated Glomerular Filtration Rate (eGFR) by MDRD-4, MDRD-4 IDMS and CKD-EPI produced by the inadequate equation selection according to the creatinine traceability in a sample of biochemistry students and to assess the effect on G categorization if numerical values of the MDRD-4 and MDRD-4 IDMS equations≥60 mL/ min/1.73 m² were used. A descriptive, analytical, cross-sectional study was performed between 2014- 2016, 100 volunteer students of biochemistry were studied. Creatininemia was determined by kinetic Jaffé methods, traceable and non-traceable to Isotopic Dilution Mass Spectroscopy (IDMS). The eGFR was estimated by the MDRD-4, MDRD-4 IDMS and CKD-EPI formula, by feeding each formula with traceable and non traceable creatinine values to IDMS. Students were classified by category G according to the results obtained. Inappropriate equation use regarding the traceability of the creatinine for which they were designed significantly changed eGFR values (p<0.05) and the proportion of young people per G stage compared to what was found with adequate use (MDRD-4. G1: 67.4% vs. 53.7%; G2: 32.6% vs. 45.3%; G3a: 0.0% vs. 1.0%. MDRD-4 IDMS. G1: 37.9% vs. 59.0%; G2: 56.8% vs. 40.0%; G3a: 5.3% vs. 1.0%. CKD-EPI. G1: 70.5% vs. 85.3%; G2: 29.5% vs. 14.7%). The use of numerical values for eGFR by MDRD-4 and MDRD-4 IDMS≥60mL/min/1.73 m² underestimated what was obtained with CKD-EPI, which can be reported numerically in that range. Both situations involve errors that affect patient renal functional categorization and prevalence in epidemiological studies.

Este trabalho teve como objetivo avaliar as consequências sobre a Taxa de Filtração Glomerular estimada (TFGe) por MDRD-4, MDRD-4 IDMS e CKD-EPI produzidas pela seleção inadequada das fórmulas, segundo a rastreabilidade da creatininemia utilizada e o efeito sobre a categorização por estágio G de TFG ao utilizar valores numéricos de MDRD-4 e MDRD-4 IDMS≥60 mL/min/1,73 m². Este é um estudo descritivo, analítico e de corte transversal com 100 alunos de bioquímica, que participaram em forma voluntária. Foi determinada a creatininemia através do métodos Jaffé cinéticos, valores rastreáveis e não rastreáveis ao Isotopic Dilution Mass Spectroscopy (IDMS). A TFGe foi estimada pela fórmula MDRD-4, MDRD-4 IDMS e CKD-EPI introduzindo em cada fórmula valores de creatinina rastreáveis e não rastreáveis a IDMS. Os estudantes foram classificados por categoria G conforme os resultados. Uso indevido das equações a respeito da rastreabilidade da creatinina conforme foram desenhadas, mudou sensivelmente os valores de TFGe (p<0,05) e a proporção de jovens por estágio G em relação ao encontrado com o uso adequado adecuado (MDRD-4. G1: 67,4% vs. 53,7%; G2: 32,6% vs. 45,3%; G3a: 0,0% vs. 1,0%. MDRD-4 IDMS. G1: 37,9% vs. 59,0%; G2: 56,8% vs. 40,0%; G3a: 5,3% vs. 1,0%. CKD-EPI. G1: 70,5% vs. 85,3%; G2: 29,5% vs. 14,7%). Utilizar valores numéricos para TFGe por MDRD-4 e MDRD-4 IDMS≥60mL/min/1,73 m² infraestimou o obtido com CKD-EPI, que pode informar-se numericamente nesse intervalo. Ambas as situações conduzem a erros que afetam a categorização funcional renal de pacientes e a prevalência em estudos epidemiológicos.

Humans , Female , Adolescent , Adult , Prevalence , Creatinine , Renal Insufficiency, Chronic , Glomerular Filtration Rate , Mass Spectrometry , Training Support , Biochemistry , Cross-Sectional Studies , Dilution , Methods