Validation Aspects of Water Treatment Systems for Pharmaceutical Products

The goal of conducting validation is to demonstrate that a process, when operated within established limits, produces a product of consistent and specified quality with a high degree of assurance. Validation of water treatment systems is necessary to obtain water with all desired quality attributes. This also provides a framework to establish a total control over the process which monitors safety, efficacy and ultimately, the process outcomes. The present overview is an attempt to discuss various aspects of validation including different approaches, components of water treatment systems, equipment qualifications, phases of performance testing, documentation and post-validation monitoring.Keywords: Validation; Water treatment systems; Quality attributes; Pharmaceutical product

The alignment of galaxy spin with the shear field in observations

Tidal torque theory suggests that galaxies gain angular momentum in the linear stage of structure formation. Such a theory predicts alignments between the spin of haloes and tidal shear field. However, non-linear evolution and angular momentum acquisition may alter this prediction significantly. In this paper, we use a reconstruction of the cosmic shear field from observed peculiar velocities combined with spin axes extracted from galaxies within $115\, \mathrm{Mpc}$ ($\sim8000 \, {\mathrm {km}}{\mathrm s}^{-1}$) from 2MRS catalog, to test whether or not galaxies appear aligned with principal axes of shear field. Although linear reconstructions of the tidal field have looked at similar issues, this is the first such study to examine galaxy alignments with velocity-shear field. Ellipticals in the 2MRS sample, show a statistically significant alignment with two of the principal axes of the shear field. In general, elliptical galaxies have their short axis aligned with the axis of greatest compression and perpendicular to the axis of slowest compression. Spiral galaxies show no signal. Such an alignment is significantly strengthened when considering only those galaxies that are used in velocity field reconstruction. When examining such a subsample, a weak alignment with the axis of greatest compression emerges for spiral galaxies as well. This result indicates that although velocity field reconstructions still rely on fairly noisy and sparse data, the underlying alignment with shear field is strong enough to be visible even when small numbers of galaxies are considered - especially if those galaxies are used as constraints in the reconstruction.Comment: 9 pages, 3 figures, accepted in MNRA

Subthalamic nucleus deep brain stimulation changes speech respiratory and laryngeal control in Parkinson\u27s disease

Adequate respiratory and laryngeal motor control are essential for speech, but may be impaired in Parkinson\u27s disease (PD). Bilateral subthalamic nucleus deep brain stimulation (STN DBS) improves limb function in PD, but the effects on respiratory and laryngeal control remain unknown. We tested whether STN DBS would change aerodynamic measures of respiratory and laryngeal control, and whether these changes were correlated with limb function and stimulation parameters. Eighteen PD participants with bilateral STN DBS were tested within a morning session after a minimum of 12 h since their most recent dose of anti-PD medication. Testing occurred when DBS was on, and again 1 h after DBS was turned off, and included aerodynamic measures during syllable production, and standard clinical ratings of limb function. We found that PD participants exhibited changes with DBS, consistent with increased respiratory driving pressure (n = 9) and increased vocal fold closure (n = 9). However, most participants exceeded a typical operating range for these respiratory and laryngeal control variables with DBS. Changes were uncorrelated with limb function, but showed some correlation with stimulation frequency and pulse width, suggesting that speech may benefit more from low-frequency stimulation and shorter pulse width. Therefore, high-frequency STN DBS may be less beneficial for speech-related respiratory and laryngeal control than for limb motor control. It is important to consider these distinctions and their underlying mechanisms when assessing the impact of STN DBS on PD

Subthalamic nucleus deep brain stimulation changes velopharyngeal control in Parkinson’s disease

Purpose—Adequate velopharyngeal control is essential for speech, but may be impaired in Parkinson’s disease (PD). Bilateral subthalamic nucleus deep brain stimulation (STN DBS) improves limb function in PD, but the effects on velopharyngeal control remain unknown. We tested whether STN DBS would change aerodynamic measures of velopharyngeal control, and whether these changes were correlated with limb function and stimulation settings. Methods—Seventeen PD participants with bilateral STN DBS were tested within a morning session after a minimum of 12 h since their most recent dose of anti-PD medication. Testing occurred when STN DBS was on, and again 1 h after STN DBS was turned off, and included aerodynamic measures during syllable production, and standard neurological ratings of limb function. Results—We found that PD participants exhibited changes with STN DBS, primarily consistent with increased intraoral pressure (n = 7) and increased velopharyngeal closure (n = 5). These changes were modestly correlated with measures of limb function, and were correlated with stimulation frequency. Conclusion—Our findings suggest that STN DBS may change velopharyngeal control during syllable production in PD, with greater benefit associated with low frequency stimulation. However, DBS demonstrates a more subtle influence on speech-related velopharyngeal control than limb motor control. This distinction and its underlying mechanisms are important to consider when assessing the impact of STN DBS on PD

Subthalamic nucleus deep brain stimulation changes speech respiratory and laryngeal control in Parkinson's disease

Adequate respiratory and laryngeal motor control are essential for speech, but may be impaired in Parkinson's disease (PD). Bilateral subthalamic nucleus deep brain stimulation (STN DBS) improves limb function in PD, but the effects on respiratory and laryngeal control remain unknown. We tested whether STN DBS would change aerodynamic measures of respiratory and laryngeal control, and whether these changes were correlated with limb function and stimulation parameters. Eighteen PD participants with bilateral STN DBS were tested within a morning session after a minimum of 12 h since their most recent dose of anti-PD medication. Testing occurred when DBS was on, and again 1 h after DBS was turned off, and included aerodynamic measures during syllable production, and standard clinical ratings of limb function. We found that PD participants exhibited changes with DBS, consistent with increased respiratory driving pressure (n = 9) and increased vocal fold closure (n = 9). However, most participants exceeded a typical operating range for these respiratory and laryngeal control variables with DBS. Changes were uncorrelated with limb function, but showed some correlation with stimulation frequency and pulse width, suggesting that speech may benefit more from low-frequency stimulation and shorter pulse width. Therefore, high-frequency STN DBS may be less beneficial for speech-related respiratory and laryngeal control than for limb motor control. It is important to consider these distinctions and their underlying mechanisms when assessing the impact of STN DBS on PD

Comparative study of efficacy and safety of intravenous ferric carboxy maltose versus iron sucrose in treatment of postpartum iron deficiency anemia

Background: As postpartum iron deficiency anemia is observed in about 65% of women in India, it is the major contributing factor and indirect cause of maternal death. Postpartum anemia may lead to postpartum depression, stress, anxiety and cognitive impairment. Adequate treatment of anemia in postpartum period will have improved life quality in women in child bearing age so this study was designed with the objective to compare the safety and efficacy of intravenous FCM versus iron sucrose in treatment of postpartum iron deficiency anemia.Methods: It was a prospective observational study of postpartum women (within 10 days of delivery) with iron deficiency anemia (7-9 gm%) who delivered in LG hospital, Ahmedabad. A sample size of 215 women was estimated based on prevalence of anemia which is 65% among postpartum women in India including dropout rate of 10% which were further divided into 2 groups. Group 1: iron sucrose group, Group 2: ferric carboxy maltose group.Results: FCM has greater rise in Hb, less side effects, and easy administration of dose as compared to iron sucrose. The rise in Hb with FCM as compared to iron sucrose is (4.6 versus 3.5 respectively).Conclusions: FCM has more safety and efficacy as compared to iron sucrose in treatment of postpartum iron deficiency anemia

Understanding verbal fluency in healthy aging, Alzheimer’s disease, and Parkinson’s disease

This is the author's accepted manuscript. This article may not exactly replicate the final version published in the APA journal. It is not the copy of record.• Objective: Verbal fluency measures are frequently part of batteries designed to assess executive function, but are also used to assess semantic processing ability or word knowledge. The goal of the present study was to identify the cognitive components underlying fluency performance. • Method: Healthy young and older adults, adults with Parkinson’s disease, and adults with Alzheimer’s disease performed letter, category, and action fluency tests. Performance was assessed in terms of number of items generated, clustering, and the time course of output. A series of neuropsychological assessments were also administered to index verbal ability, working memory, executive function, and processing speed as correlates of fluency performance. • Results: Findings indicated that regardless of the particular performance measure, young adults performed the best and adults with Alzheimer’s disease performed most poorly, with healthy older adults and adults with Parkinson’s disease performing at intermediate levels. The exception was the action fluency task, where adults with Parkinson’s disease performed most poorly. The time course of fluency performance was characterized in terms of slope and intercept parameters and related to neuropsychological constructs. Speed of processing was found to be the best predictor of performance, rather than the efficiency of executive function or semantic knowledge. • Conclusions: Together, these findings demonstrate that the pattern of fluency performance looks generally the same regardless of how performance is measured. In addition, the primary role of processing speed in performance suggests that the use of fluency tasks as measures of executive function or verbal ability warrants reexamination.This work was conducted with grant support from the Kansas City Life Sciences Institute. Additional support was provided by the Digital Electronics Core of the Center for Biobehavioral Neurosciences in Communication Disorders, grant number P30 DC-005803, for assistance with the development of the digital ink assessment

Effects of a scalable home-visiting intervention on child development in slums of urban India: evidence from a randomised controlled trial

Background: An estimated 63.4 million Indian children under 5 years are at risk of poor development. Home visits that use a structured curriculum to help caregivers enhance the quality of the home stimulation environment improve developmental outcomes. However, achieving effectiveness in poor urban contexts through scalable models remains challenging. Methods: Using a cluster randomised controlled trial, we evaluated a psychosocial stimulation intervention, comprising weekly home visits for 18 months, in urban slums of Cuttack, Odisha, India. The intervention is complementary to existing early childhood services in India and was run and managed through a local branch of a national NGO. The study ran from August 2013 to July 2015. We enrolled 421 children aged 10–20 months from 54 slums. Slums were randomised to intervention or control. Primary outcomes were children's cognitive, receptive language, expressive language and fine motor development assessed using the Bayley‐III. Prespecified intent‐to‐treat analysis investigated impacts and heterogeneity by gender. Trial registrations: ISRCTN89476603, AEARCTR‐0000169. Results: Endline data for 378 (89.8%) children were analysed. Attrition was balanced between groups. We found improvements of 0.349 of a standard deviation (SD; p = .005, stepdown p = .017) to cognition while impacts on receptive language, expressive language and fine motor development were, respectively, 0.224 SD (p = .099, stepdown p = .184), 0.192 SD (p = .085, stepdown p = .184) and 0.111 (p = .385, stepdown p = .385). A child development factor improved by 0.301 SD (p = .032). Benefits were larger for boys. The quality of the home stimulation environment also improved. Conclusions: This study shows that a potentially scalable home‐visiting intervention is effective in poor urban areas