46 research outputs found

    Stability Indicating RP-HPLC Method Development and Validation for Related Substances of Testosterone Undecanoate in Capsule Dosage Form

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    In this study, the stability-indicating RP-HPLC based Related substances method was developed for the estimation of Testosterone Undecanoate and its related degradation impurities in capsule dosage form and validated according to ICH guidelines. There are no official compendial methods available for the estimation of Testosterone Undecanoate in both bulk and pharmaceutical dosage forms. This developed gradient RP-HPLC method is found useful in achieving the complete separation and quantification of all possible impurities that could be present after degradation with suitable resolution criteria between the analyte of interest and related impurities. The Optimized chromatographic conditions, summary results of Validation, Degradation results of Sample and API are furnished in Tables 47, 48, 49 & 50 respectively. The Validation and Degradation results were found to be complying with the acceptable limits. Hence the developed method was found to be stability-indicating for the estimation of Testosterone Undecanoate and its related degradation impurities in Capsule dosage form. CONCLUSION: The developed stability-indicating Related Substances method for the determination of Testosterone Undecanoate and its degradation impurities using the RP-HPLC gradient method was found to be simple, accurate, precise, robust, rugged, and specific. Hence this method can be used for routine quality control and stability analysis. Identification and characterization of the impurities present may be taken up as further research in the study

    Development of Deep Learning based Intelligent Approach for Credit Card Fraud Detection

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    Credit card fraud (CCF) has long been a major concern of institutions of financial groups and business partners, and it is also a global interest to researchers due to its growing popularity. In order to predict and detect the CCF, machine learning (ML) has proven to be one of the most promising techniques. But, class inequality is one of the main and recurring challenges when dealing with CCF tasks that hinder model performance. To overcome this challenges, a Deep Learning (DL) techniques are used by the researchers. In this research work, an efficient CCF detection (CCFD) system is developed by proposing a hybrid model called Convolutional Neural Network with Recurrent Neural Network (CNN-RNN). In this model, CNN acts as feature extraction for extracting the valuable information of CCF data and long-term dependency features are studied by RNN model. An imbalance problem is solved by Synthetic Minority Over Sampling Technique (SMOTE) technique. An experiment is conducted on European Dataset to validate the performance of CNN-RNN model with existing CNN and RNN model in terms of major parameters. The results proved that CNN-RNN model achieved 95.83% of precision, where CNN achieved 93.63% of precision and RNN achieved 88.50% of precision

    Anthropometry of Malaysian young adults

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    This paper presents the results of an anthropometric data collected from polytechnic students in Malaysia. A total of 1032 (595 males and 437 females) students participated in the study. Their ages ranged from 18 to 24 years. A total of 34 anthropometric dimensions were measured. Descriptive statistics such as mean, standard deviation, standard error of mean, coefficient of variation, minimum, maximum and percentile for each parameter were estimated. In addition, the comparison between Malaysia anthropometric data and Thailand (South) anthropometric data were also presented. The results show that there is a total of 12 and 11 (of dimensions parameters) significant differences (p < 0.05) between the male and female adults respectively

    Diethyl 2-{[3-(2-meth­oxy­benz­yl)thio­phen-2-yl]methyl­idene}malonate

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    In the title compound, C20H22O5S, the dihedral angle between the mean planes through the thio­phene and benzene rings is 75.2 (1)°. The meth­oxy group is essentially coplanar with the benzene ring, the largest deviation from the mean plane being 0.019 (2) Å for the O atom. The malonate group assumes an extended conformation

    (3-Phenyl­sulfanyl-1-phenyl­sulfonyl-1H-indol-2-yl)methyl acetate

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    In the title compound, C23H19NO4S2, the indole ring system makes dihedral angles of 89.6 (1) and 84.5 (8)° with the phenyl­sulfonyl and phenyl­sulfanyl rings, respectively. In the crystal, the mol­ecules are linked into C(10) chains running along the c axis by an inter­molecular C—H⋯O hydrogen bond. In addition, the crystal packing is stabilized by C—H⋯π inter­actions

    Conceptual design and prototype of smart calling system research

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    This study is conducted with the intention of designing, developing and testing a prototype of a Smart Calling System for Mechanical Engineering Department (MED) in Polytechnic Sultan Azlan Shah (PSAS), Behrang Perak. The MED building is consists of 3 floors of staff offices, 4 floors of classrooms and a total of 1388 students. As this involves a large number of students, there is a frequent movement of students flow into the department office to meet their relevant lecturers. The current communication method in MED which is using telephone and PA system is not very effective and has created an unpleasant environment in the staff s office. Therefore the objective of this study is to develop a Smart Calling System for the communication purpose in the MED offices. This study was planned based on the Design Process Model (DPM) activity. Results of the developed prototype showed that it provides a better communication tool between the lecturers and students

    Expressing OsiSAP8, a Zinc-Finger Associated Protein Gene, Mitigates Stress Dynamics in Existing Elite Rice Varieties of the 'Green Revolution'

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    Key message: Overexpression of OsiSAP8 driven by Port Ubi2.3 from Porteresia coarctata imparts drought and salinity stress tolerance in transgenic rice. Stress associated proteins (SAPs) possess the zinc-finger domains that are wildly evolving functional and conserved regions/factors in plants to combat abiotic stresses. In this study, the promoter region of OsiSAP8, an intron-less, multiple stress inducible gene, was compared in silico with a strong constitutive promoter, Port Ubi2.3. This resulted in developing rice, resistant to drought and salinity expressing OsiSAP8 promoted by Port Ubi2.3. (Porteresia coarctata), through Agrobacterium-mediated transformation in the popular rice varieties, IR36 and IR64. Southern blot hybridization confirmed the integration of OsiSAP8, and the T0 transgenic lines of IR36 and IR64 were evaluated for their drought and salinity tolerance. The IR36-T1 progenies showed an enhanced tolerance to water withhold stress compared to wild type and IR64-T1 progenies. Physiological parameters, such as the panicle weight, number of panicles, leaf wilting, and TBARS assay, showed the transgenic IR36 to be superior. The transgenic lines performed better with higher 80-95% relative leaf water content when subjected to drought for 14 days. Gene expression analysis of OsiSAP8 in IR36 T1 showed a 1.5-fold upregulation under mannitol stress. However, IR64 T1 showed a two-fold upregulation in NaCl stress. An enhanced drought and salinity stress tolerance in the transgenic IR36 cultivar through overexpression of OsiSAP8 was observed as it had a native copy of OsiSAP8. This is perhaps the first study using a novel ubiquitin promoter (Port Ubi2.3) to generate drought and salinity stress-tolerant transgenic rice. Thus, we report the overexpression of a rice gene (OsiSAP8) by a rice promoter (Port Ubi2.3) in rice (IR36) to resist drought and salinity

    Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial

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    Background Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy

    Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

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    Background: Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. Methods: The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). Findings: Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29–146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0– 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25–1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39–1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65–1·60]; p=0·92). Interpretation: These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention

    Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

    Get PDF
    Background: Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. Methods: The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). Findings: Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29–146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0– 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25–1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39–1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65–1·60]; p=0·92). Interpretation: These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention
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