Standard Operation Process Research Articles

Development of standard manufacturing process of Tryushanadya Lauha – An organo-metalic preparation

Tryushanadya Lauha (TL) is one of the herbo-mineral formulations in many Ayurvedic texts. Tryushanadya Lauha consists Loha Bhasma and Tryushana, which includes Pippali (Piper longum Linn), Maricha (Piper nigrum Linn), and Shunti (Zingiber officinale Roscoe), Cavya (Piper chaba Hunter), Citraka (Plumbago zeylanica Linn), Bakuchi (Psoralea Corylifolia Linn), and Lavana (salt), which includes Saindhava (Sodium chloride), Aubhida (sodium carbonate), Vida (Ammonium chloride), and Sauvarchala (Sodium sulphate). This study is an effort to develop the standard operating process for manufacturing of Loha Bhasma and Tryushanadya Lauha. As per the reference of Rasatarangini, Loha Bhasma (incinerated ash of iron) was prepared in three batches. The processing of Loha Bhasma (ash of iron) was performed by adopting, Shodhana (purification), a special heating process and Marana (incineration). For the process of Levigation decoction of Triphala was used. Puta (heating process) was given in Electric Muffle Furnace at a temperature of 500 0C. The percentage of loss was 49.9% after purification. During Loha Bhasma (incinerated ash of iron) preparation 14.7%loss and 85.3% gain were observed. This Loha Bhasma was used for the preparation of TL. During TL preparation, 0.6% loss was observed & 99.3% was obtained. This study will give the direction for the standard manufacturing process of Loha Bhasma (incinerated ash of iron) and Tryushanadya Lauha.

Pharmaceutical Standardization of Muktashukti Bhasma and Muktashukti Pishti

Shukti is an important component of Sudhavarga, the most recent class in the subject of Rasa Shastra. According to the availability, two forms of Shukti have been stated in Rasa Shastra texts: Jalashukti and Muktashukti. Muktashukti is considered for the study. This study has tried to develop the standard operating process for manufacturing Muktashukti bhasma and Muktashukti pishti. Three batches of MSB & MSP were prepared from the purified Muktashukti. While manufacturing three batches same raw material and manufacturing instruments were used. Before processing for Bhasma or Pishti, the purification process is advocated for Muktashukti. Kanji (Rice gruel) was used for purification as per textual reference. Purified Muktashukti was levigated with Rose water to obtain Pishti. However, for Bhasma preparation, the Muktashukti was triturated with Aloe vera juice, and then heating was done in an Electric muffle furnace. 7 liters of Kanji was taken for 500g of Muktashukti Shodhana by Swedana for 3hrs in Dolayantra, with an average weight rise of 96.24% and a weight loss of 3.76% during the Shodhana method. During MSB preparation, a 10% loss was observed & 90% of Bhasma was obtained. However, in MSP preparation, a 12.14% loss was observed & 87.86% was obtained. This study will give the direction related to the duration of levigation and temperature regulation while Muktashukti Bhasma preparation. For Pishti preparation, the wet grinder was used, which will provide exact rotation and duration to obtain the proper pishti from Muktashukti.

An optimized method for intratracheal instillation in mice

Non-invasive intratracheal instillation is an important method for direct exposure of the respiratory tract which is commonly used in toxicology, environmental science, and other research fields. However, there is no standard operating process for non-invasive intratracheal instillation. To keep the reliability and accuracy of intratracheal instillation is vital, especially, for animal models of sub-chronic or chronic exposure which may need repeated operations performed on many animals. In this study, we improved the intratracheal instillation operation and verified the accuracy and reliability of this method. Adult female BALB/c mice were treated with ink solution, normal saline and PM2.5 suspension by the described intratracheal instillation method. After a short recovery, the mice were killed. The distribution of ink in the lungs and gastrointestinal tract of the mice was observed anatomically, and the dispersion of PM2.5 in the lungs and the status of lung injury were observed by pathological staining after 24 h. Scattered ink blots were observed in the lungs of the mice with instillation inks, but not in their gastrointestinal tract. Pathological staining of mouse lung showed that PM2.5 was distributed at the end of bronchiole and alveolar cavity, and caused diffuse acute lung injury in the mice. This study shows that the non-invasive intratracheal instillation method has good accuracy and reliability, which can reduce the use of mice, do less harm to the mice, and then improve 3R animal welfare. This method can be applied to establish a mouse model of short-term or long-term exposure through the respiratory tract.

Expert consensus on the space maintainer in children

The Society of Pediatric Dentistry of Chinese Stomatological Association convened experts from well-known medical colleges and hospitals in China to discuss the clinical applications of space maintainer in children. The research results and experiences in diagnoses and treatments at home and abroad in recent years were used for reference. After multiple discussions and revisions, a consensus on recommended application was developed. The expert consensus formulate the design, indication selection and standardized clinical operation process of space maintainer in children, so as to guide and standardize the clinical application of space maintainer in children and to accelerate its clinical promotion.

Fabricated Components Hoisting Activity Recognition and Collision Analysis Based on Inertial Measurement Unit IMU

The prefabricated components are an important aspect of prefabricated constructions. Based on three possible collision situations when the fabricated component is being lifted during the installation phase, the aim of this study is to investigate how to prevent effective collision between the hoist and the barrier, and establish the standardized operation process (SOP) of using the Inertial Measurement Unit (IMU) to detect the hoisting collision of fabricated building components. The (IMU) technology is used in the collection of lifting activities data. The hoisting activity will be divided into four situations: classification and recognition of stationary, ascending, advancing, and descending of components; use of the K-Nearest Neighbor (KNN) algorithm and the Random Forest (RF) algorithm for data processing to recognize the hoisting activities of assembled components; construction of the hoisting activity recognition model; determination of the best recognition position of the IMU; further collision analysis based on the recognition of the hoisting of assembled components. The collision is divided into direct collision, sudden stop, and detour in a specific space from obstacles. Image analysis of the three types of collision activities will be carried out to help perceive lifting activities in advance and reduce loss resulting from collisions caused by components. According to the systematic research and discussion of hoisting activity recognition and collision behavior, it provides a reasonable basis and ideas for solving hoisting collisions in prefabricated buildings and aids in the use of inertial sensors in construction to provide assistance for construction automation.

Preclinical study of human umbilical cord mesenchymal stem cell sheets for the recovery of ischemic heart tissue

BackgroundHuman umbilical cord mesenchymal stem cells (hUC-MSCs) have been widely used due to their multipotency, a broad range of sources, painless collection, and compliance with standard amplification. Cell sheet technology is a tissue engineering methodology requiring scaffolds free, and it provides an effective method for cell transplantation. To improve the therapeutic efficacy, we combined hUC-MSCs with cell sheet technology to evaluate the safety and efficacy of hUC-MSC sheets in preclinical studies using appropriate animal models.MethodshUC-MSC sheets were fabricated by hUC-MSCs from a cell bank established by a standard operation process and quality control. Cytokine secretion, immunoregulation, and angiopoiesis were evaluated in vitro. Oncogenicity and cell diffusion assays of hUC-MSC sheets were conducted to verify the safety of hUC-MSCs sheet transplantation in mice. To provide more meaningful animal experimental data for clinical trials, porcine myocardial infarction (MI) models were established by constriction of the left circumflex, and hUC-MSC sheets were transplanted onto the ischemic area of the heart tissue. Cardiac function was evaluated and compared between the experimental and MI groups.ResultsThe in vitro results showed that hUC-MSC sheets could secrete multiple cellular factors, including VEGF, HGF, IL-6, and IL-8. Peripheral blood mononuclear cells had a lower proliferation rate and lower TNF-α secretion when co-cultured with hUC-MSC sheets. TH1 cells had a smaller proportion after activation. In vivo safety results showed that the hUC-MSCs sheet had no oncogenicity and was mainly distributed on the surface of the ischemic myocardial tissue. Echocardiography showed that hUC-MSC sheets effectively improved the left ventricular ejection fraction (LVEF), and the LVEF significantly changed (42.25 ± 1.23% vs. 66.9 ± 1.10%) in the hUC-MSC transplantation group compared with the MI group (42.52 ± 0.65% vs. 39.55 ± 1.97%) at 9 weeks. The infarct ratio of the hUC-MSCs sheet transplantation groups was also significantly reduced (14.2 ± 4.53% vs. 4.00 ± 2.00%) compared with that of the MI group.ConclusionAllogeneic source and cell bank established by the standard operation process and quality control make hUC-MSCs sheet possible to treat MI by off-the-shelf drug with universal quality instead of individualized medical technology.

Application of Urban Management Pattern Innovation in Smart City Construction

Under the background of smart city construction, urban management has broken through the drawbacks of the traditional management mode, and more and more changes towards the development pattern of multi-agent participation, standardization and normalization. The development of modern science and technology has promoted the development of cities. This urban management model can effectively promote the formation of the current urban management pattern. After digital cities and smart cities, the development of information and communication technology has boosted the current smart city construction. At present, the innovation of urban management mode under the smart city is based on the support of urban public information platform, mobilizing the wide participation of the public through multi department collaborative management, and has a more standardized closed-loop operation process.

ПРОБЛЕМЫ СОЗДАНИЯ ДОКУМЕНТАЦИИ СИСТЕМЫ ОБЕСПЕЧЕНИЯ КАЧЕСТВА

The article is devoted to the development of quality system documents for the pharmacy organization. The legislation of the Republic of Belarus, as well as the Eurasian Economic Union, requires the development and maintenance of the quality assurance system, the quality management system, the pharmaceutical quality system in a pharmacy organization, a distributor or manufacturer of medicinal products. The article presents the comparative analysis of regulatory requirements as well as approaches of the international standards ISO series to the construction of the quality systems and processes documentation. Such documents as the Quality Manual or its equivalent, Standard Operating Procedures (SOP) and Process Instructions are the most difficult to develop. The distribution of responsibility for processes within the organization is difficult to understand. On the example of RUE «BELPHARMATSIYA» it is shown how the processes in the pharmacy organization can be documented and responsibility for their implementation can be stated. The functioning of the quality system depends on the clarity of the documentation structure and its development and circulation organization. It is the responsibility of the organization authorities to maintain effective functioning of this system.

Quality Assessment of Bottled and Unbottled Drinking Water in Bangladesh

The demand for bottled drinking water in Bangladesh is becoming popular due to the lack of safe drinking water sources. The present study was carried out to assess the water quality and public health impacts of local brands of bottled drinking water and tube-well water, compared to the imported ones. Several state-of-the-art techniques were employed to determine the contents of pH, EC, salinity, chloride, nitrates, nitrites, fluoride, sulfates, phosphates, bicarbonate, turbidity, color, total hardness, and total dissolved solids in the studied water samples. The measured data show that the level of dissolved minerals in the local branded bottled water is very low (with an exception for sample codes D1 and D8), while imported brands, Zamzam water, and tube-well water contain satisfactory level of minerals and fulfill Dietary Reference Intake requirements. Total coliform, fecal coliform, and E. coli were found to be absent in local brands of bottled water and tube-well water. On the other hand, concentrations of some radionuclides 40K, 238U, 226Ra, 210Pb, 210Po, 222Rn, 137Cs, and 232Th in local bottled water and tube-well water were found to be less than the permissible level given by WHO (2011). The results reveal that local bottled drinking water manufacturing companies may not be following standard guidelines and quality control steps properly. Thus, improvement in their standard operating process is urgently needed to ensure strict compliance with guidelines set by Bangladesh standards and testing institutions.

National expert consensus on the operation and management of deep vein catheterization in severe burn patients (2020 version)

Deep vein catheterization is an important method to prevent and treat burn shock in severe burn patients, monitor hemodynamic changes and provide venous nutritional support. Although deep vein catheterization has been applied widely, there is no standard operation and management process. In order to guide the operation and management of deep vein catheterization in severe burn patients in a more scientific and standard manner, the consensus writing group organized domestic experts in burn field, most of whom are members of the 10th Committee of Chinese Burn Association to discuss and reach a consensus mainly in selection of deep vein catheter and the catheterization site, the method of catheterization operation, catheter maintenance, and prevention and treatment of catheter-related complications. This consensus aims to provide practical basis and guidance for the operation and management of deep vein catheterization in severe burn patients.

Intelligent network operation and maintenance system based on big data

With the deepening of network system construction, it is more and more important to monitor the operation status and performance of business system, network system, network equipment, host equipment, database and middleware; at the same time, the requirements for the depth, breadth and granularity of network information security monitoring are constantly improved, and the traditional network operation and maintenance is more and more inadequate. The “intelligent network operation and maintenance system based on big data” can realize the operation monitoring of network, host, business application, network equipment, desktop terminal, etc., and build an electronic platform based on big data to realize the standard operation and maintenance process, achieve the goal of real-time monitoring and closed-loop control.

Smart Operation and Maintenance Platform of Protection Relay Based on Mobile Sensing and Big Data

In order to solve the current network limitations and human-computer interaction limitations of relay protection and automation in power systems, an intelligent operation and maintenance management platform for electrical secondary equipment based on mobile sensing and big data is proposed. First, the existing problems in the standardization operation and data integration in the relay protection work at this stage are explained, and the significance of the construction of this platform is pointed out. Then the application modes of mobile sensing technology and big data technology in power system is analyzed, proposing the system architecture and functional architecture of the system, and the interaction mode between the mobile terminal and the master station in the system is explained. Finally, the specific functions of the system's standardized operation process and intelligent operation inspection are explained, and the effects of the intelligent operation and maintenance control of the secondary equipment under the original mode and the new mode are compared.

An Empirical Analysis of Sustainable Denim Washing Technology in the Apparel Industries

Over the last few decades, a lot of innovations and development works had already made denim “classic” in the fashion cycle. The modern consumers of today’s world are not only devoting themselves on clothing comfort but also emphasizing on economic and environmental sustainability. As a result, there has been increasing interests in terms of using environment friendly, non-toxic and highly biodegradable wet and dry process of denim washing technology, which is a combination of both the mechanical and chemical washing process. These are generally applied for denim garments and casual wearing. Without garment washing technology, apparels can’t draw proper attention on its end-users, just because it includes very few value added properties (such as hand feel, clothing comfort) with a view to attaining customer satisfaction. In addition, it improves the quality characteristics of apparels within low price margin. Some ecofriendly dry process of garments washing includes whiskering, hand sand, grinding, destroy effects. On the contrary, some wet process (such as enzyme wash, super white wash, bleach wash, acid wash, acid-stone wash, enzyme-stone wash and stone wash) utilizes very less amount of toxic dyes and chemicals. This research work simply made a general discussion related to the different types of garments dry and wet process. It also dealt with necessary apparatus, SOPs (Standard Operating Process), operational steps of sustainable and ecofriendly denim washing technology. Within limited global resources, it can help manufacturers and garments washing technologists to diversify the product and market of apparel trades.

Effectiveness of individual audio-visual coaching, respiratory modulated stereotactic body radiotherapy for localized hepatocellular carcinoma: Analysis of 29 cases from a single academic radiotherapy center.

Objectives:Recently, Stereotactic Body Radiotherapy (SBRT) has been suggested for managing hepatocellular carcinoma (HCC) curatively. Thus, we conducted this clinical study to evaluate retrospectively the effect of individualized audio-visual (AV) coaching, respiratory modulated SBRT.Materials and Methods:Between 2014 and 2018, 29 patients with inoperable Barcelona Clinic Liver Cancer (BCLC) stage 0-B HCC received AV coaching, respiratory-modulated SBRT. We constructed a task-oriented multidisciplinary team to establish a standard operation process of respiratory modulation procedures and developed our AV coaching devices. In the training period, a goodness-of-fit test was applied individually. SBRT was delivered with a total dose of 40–54 Gy in 5–6 fractions individually. Freedom from local progression (FFLP) and overall survival (OS) were estimated using SPSS (version 17, SPSS Inc., Chicago, IL, USA) life tables.Results:The patient characteristics were as follows: 32.7 ± 16 mm in maximum tumor diameter (range 11–94); BCLC stage 0: 3.4%, BCLC A: 48.3%, BCLC B: 48.3%; Child-Pugh classification A: 86.2%, Child-Pugh classification B: 13.8%, and a median of 2 prior liver-directed treatments (range 0–7). One-, 2-, and 3-year rates of FFLP of SBRT were 96.6%, 96.6%, and 96.6%, respectively. One-, 2-, and 3-year rates of OS were 81.5%, 72.4%, and 67.2%, respectively. No adverse event (AE) occurred in 41.4% of patients, 48.3% developed grade (G) 1–2 AE, 10.3% had G3 AE and none had G4-5 AE.Conclusion:Respiration-modulated SBRT is a promising noninvasive treatment option for patients with inoperable and localized HCC. Our data show that SBRT provides comparable tumor control to historical curative options like surgery and radiofrequency ablation of localized tumors. Thus, we are conducting a further prospective clinical trial with the intent to demarcate the clinical effectiveness of SBRT in a larger population of patients with HCC.

Diagnostic performance of quantitative fecal immunochemical test in detection of advanced colorectal neoplasia

Objective: To evaluate the diagnostic performance of quantitative fecal immunochemical testing (FIT) and to provide reference for designing effective colorectal cancer (CRC) screening strategy in China. Methods: Based on an ongoing randomized controlled trial comparing the colorectal cancer screening strategies, this current study involved 3 407 participants aged 50-74 years who had undergone colonoscopies. All the feces samples were collected from the participants prior to receiving the colonoscopy. Fecal hemoglobin (Hb) was tested by FIT following a standardized operation process. Diagnosis-related indicators of FIT were calculated using the colonoscopy results as the gold standard. Results: Among the 3 407 participants, the mean age (SD) as 60.5 (6.3) years and 1 753 (51.5%) were males. The participants involved 28 (0.8%) CRCs, 255 (7.5%) advanced adenomas, 677 (19.9%) nonadvanced adenomas, and 2 447 (71.8%) benign or negative findings. With an overall positivity rate of 2.8% (96/3 407) at the recommended cutoff value of 20 μg Hb/g, the sensitivities of FIT for both CRC and advanced adenoma were 57.1% (95%CI: 37.2%-75.5%) and 11.0% (95%CI: 7.4%-15.5%), respectively, with the corresponding specificity as 98.4% (95%CI: 97.8%-98.8%). At a decreased cut-off value of 5 μg Hb/g, the sensitivities for detecting CRC and advanced adenoma increased to 64.3% (95%CI: 44.1%-81.4%) and 16.5% (95%CI: 12.1%-21.6%), respectively, but the specificity reduced to 95.2% (95%CI: 94.4%-95.9%). The areas under the ROC curve for CRC and advanced adenoma were 0.908 (95%CI: 0.842-0.973) and 0.657 (95%CI: 0.621-0.692), respectively. Of the diagnostic performance, there were no significant differences noticed by different sex and age groups. Conclusions: In our study, the quantitative FIT showed modest sensitivity in detecting CRC but limited sensitivity in detecting advanced adenoma. In population-based CRC screening programs, the quantitative FIT had the advantage of adjusting the positive threshold based on the targeted detection rate and available resource load of colonoscopy.

Assessment of Performance of Functional and Partial Functional Water Supply Systems in Sunsari District of Nepal

Only 25.4% of water supply projects are fully functional in Nepal though the target of government is to provide access to safe water supply and sanitation facilities for all. Therefore a study for comparing the performance of the functional (Itahari) and partial functional (Duhabi) water supply and sanitation project after management transfer is needed to assess the indicators to improve the status of water supply and sanitation projects. Both the projects are of Sunsari district. Purposive Sampling technic was applied based on sample size of central limit theorem. Scheduled Questionnaire Survey, Expert Consultation, Focus Group Discussion and Water Sample Test were done for primary source of data whereas reports. Journals, project reports, similar studies, books, websites and audit reports were reviewed for secondary source of data. Comparative performance of both the projects was analyzed based on technical, financial and institutional indicators. From the study it was found that pressure of flow, water demand of users, chlorine demand, and quick response of staffs, water quality and open defecation free were maintained at Itahari whereas such features were lacking in Duhabi Water Supply and Sanitation Project. It was found high tariff rate, timely payment and a business plan of Itahari WSSP was better resulting into better financial performance of the system in comparison to that of Duhabi. Based on policy in both water supply and sanitation projects 33% of women along with a vital post and marginalize group based on service area representation were found. In Itahari Water Supply Project, for per thousand of connection 3.66 staffs were appointed whereas in partial functional Duhabi Water Supply System 1.91 staffs were found for per thousand connections. Itahari WSSP had maintained a citizen charter, complaint box, information system, detailed design report, As Built Drawings, Standard Operating Process and project information’s were documented which causes the management of the system effective for implementation of reliable and satisfactory of the system whereas these things need to be improved in case of Duhabi for creating the confidence about the service.

Popularization and application of the capillary foam deliquification technology in horizontal wells with low pressures and low liquid flow rates: A case study on middle–shallow gas reservoirs in the Western Sichuan depression

The application effect of the foam deliquification technology in horizontal wells is poor because the foaming agent fails to reach the target location. In view of this, the adaptability of the capillary foam deliquification technology in the Western Sichuan Gas Field in the Sichuan Basin was analyzed from the aspects of gas flow rate, liquid flow rate and casing program of gas wells, and the design of injection depth and the selection of capillary size, tool string parameters (the maximum length and the minimum counterweight) and foam deliquification parameters (foaming agent type selection, ground injection concentration and rate) were optimized. Then, a standardized capillary operation process was developed. Finally, a field application test was carried out. And the following research results were obtained. First, the capillary foam deliquification technology has a popularization potential in the horizontal wells of middle–shallow depth, low pressure and low liquid flow rate, but it is not suitable for the wells with too low gas flow rate, too high liquid flow rate or too high condensate content. Second, the well deviation angle at the injection depth shall be between 70° and 80°, the selection of capillary size shall satisfy the requirement for tension strength by the well depth, the foam deliquification parameters shall be optimized based on the specific well conditions and the liquid loading characteristics, and the capillary operation shall comply with the standardized process. Third, by the end of July 2017, the capillary foam deliquification technology had been successfully applied in 9 horizontal wells in the Western Sichuan Gas Field with a cumulative gas increment of 295 × 104 m3. Fourth, 4 supporting technologies of the capillary foam deliquification are formed, including capillary sticking prevention, integrated agent injection and pressure measurement, combined cleaning and deliquification and capillary wellhead suspension. In conclusion, the capillary foam deliquification technology provides a technological support for the deliquification and production stabilization of horizontal wells with middle–shallow depth, low pressures and low liquid flow rates in the Western Sichuan Depression, and also provides technological reference for the deliquification of horizontal wells in the similar type of gas reservoirs.

18개월의 복합 운동이 시설 거주 남성노인의 체구성, 심혈관 기능과 하지 등속성 근기능에 미치는 영향

The purpose in this study is to investigate the influence of 18-month combined exercise program on body composition, cardiovascular function and isokinetic leg strength in older men living in residential aged care facilities. 12 healthy older men over 65 years without any clinical problem participated in the combined exercise program. The combined exercise program was composed of over 18 months, 3 times per week and 40 minutes per day. Body composition, cardiovascular fitness, and isokinetic leg strength were measured at pre-exercise, 6-month after exercise, 12-month after exercise, and1 8-month after exercise with the same standard operating process. The data were analyzed by using descriptive statistics, one-way ANOVA with repeated measures, and Dunnett post-hoc.. In this study, the results are as follows: First, the 18-month combined exercise did not significantly change in body composition related factors except basal metabolic rate. Basal metabolic rate significantly increased in 18-month after exercise. Second, After the long term exercise, peak hear t rate significantly increased. Third, in factors of muscle strength, the long-term exercises significantly enhanced bilateral leg muscle strength at 60°/sec isokinetic conditions only. In conclusion, the 18- month combined exercise has a positive effect on basal metabolic rate and peak heart rate, and 60°/sec leg muscle strength in older men living in residential aged care facilities.

The establishment of a chyle testing method based on n-hexane extraction system

Objective To set up a chyle (n-hexane) testing method based on n-hexane extraction system. Methods The hydrothorax specimen which was positive in chyle testing was selected and the feasibility was evaluated by replace Diethyl ether with n-hexane. The optimal extraction volume ratio for the new chyle testing was confirmed and sultan Ⅲ dye process was improved. Then, the new chyle testing method and its standard operation process was established.A total of 120 specimens with triglyceride(TG)in different levels were collected and divided into three groups with 40 specimens for each group (group A. TG≤1.7 mmol/L; B. 5.6<TG<12.8 mmol/L; C. TG≥12.8 mmol/L). Then, 50 body fluid specimens were collected and used to confirm the above test results. A total of 134 real body fluid specimens were used to assessment the clinical using by review and calculating the clinical coincidence rate. Results N-hexane can replace Diethyl ether in the Chyle test. The extraction volume ratio of 1 ml sample plus 400 μl N-hexane is the best one and the sultan Ⅲ tube dying method is better than former direct smear. Compared with the old Chyle test using Diethyl ether, the new Chyle test using N-hexane is in good consistency with the Kappa value 0.95. The clinical coincidence rate of the above Chyle test reaches 94.8%(127/134) after the verification of 134 specimens. Conclusions A new N-hexane test is established successfully. It was convenient to operate with high security and little contamination and thus has a wide clinical application value.(Chin J Lab Med, 2018, 41: 527-530) Key words: Chyle; Hexanes; Ethyl ethers; Clinical laboratory techniques

Misconduct in Clinical Research in India: Perception of Clinical Research Professional in India

Misconduct in clinical research is an unfortunate reality and widespread. Researchers are expected to conduct research and report results honestly. However, that is not how clinical trials always get done. Good Clinical Practice (GCP) guideline is adopted internationally as a standard operating process for purpose of conducting, recording or reporting clinical trials. However, unavailability of international harmonized framework for misconduct management makes clinical research industry vulnerable to commit misconduct. Most of the cases of misconduct are probably not published. They are not recognized or covered up altogether. Misconduct and fraud can be due to any reasons and of various types. In all circumstances, any misconduct should be handled strictly and related regulations should be at place to prevent occurrences. Very few cases of scientific misconducts have been identified or reported in India. However, there is no evidence that all clinical trials conducted in India meet ethical standards and misconduct does not exist. Rather it is more likely that the scientific misconduct amongst researcher have not been systematically investigated. This article discusses the possible reasons for the occurrence of scientific misconduct and explores options, which can possibly help prevent such instances.