Assessing Variabilities for Bioanalytical Methods

Variability arises from many different sources. In the pharmaceutical industry, it is important that these variabilities are estimated and controlled in order to provide a good quality and safe product. The FDA has certain guidelines dealing with precision that need to be followed. This analysis tested five different methods from SAS® to assess which test should be used. These five tests include methods from PROC VARCOMP – ML, REML, TYPE1 and MIVQUE0 and from PROC MIXED – REML. This analysis simulated data to get an estimate of precision under true values. The simulation only dealt with two parameters where variability could arise and it had four possible values for each. The simulation also took into account the number of labs and number within, which also had four values each, in total created 252 different scenarios. Bias and mean square error (MSE) means were used to evaluate these five methods. Data was also obtained from Merck & Co. and CV (RSD) values were found to check precision of various tests. Generally speaking, the bias and MSE decrease as the sample size increases for all methods. MIVQUE0 was concluded to be the best test for checking variability. If the sample size is high, the testing method does not matter because all will produce the same or similar results, however, the pharmaceutical industry does not have the luxury of having many lab assays available. Therefore, these results are based on providing the best recommendation for the current situation and not an ideal situation.M.P.H., Public Health -- Drexel University, 201

An Efficient Image Fusion of Visible and Infrared Band Images using Integration of Anisotropic Diffusion and Discrete Wavelet Transform

Image fusion is a technique that combines two source images to generate more informative target image. It plays a vital role in medical image investigation, military, navigation, etc. visible images offer efficient texture detail with high spatial resolution. In contrast, based on the radiation difference infrared images are able to differentiate target from their background. There are many algorithms that helps in preserving the edges of image like Bilateral filter, anisotropic diffusion (ADF). This paper integrates Anisotropic Diffusion and Karhunen-Loeve (KL)Transformation with discrete wavelet transform (DWT). In proposed Method, DWT decomposes into four sub-bands. ADF is applied on approximation sub-band and absolute maximum selection is applied on other three sub-bands. ADF decomposes the image into detailed layer and base layer. Base layer and Detailed layer are calculated using Kl- Transformation and linear combination respectively. Once fusion is done, inverse DWT is applied on all sub-bands. The experimental outcomes depict that the offered approach result with sharp edges of the image. The proposed algorithm is evaluated on standard dataset Like Duine_Sequence, Tree_sequence, Street dataset. Standard metrics like Average Gradients and Spatial Frequency metrics are used to evaluate the performance of the image

Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study

BACKGROUND: Due to the bleeding risk of full-dose systemic thrombolysis and the lack of major trials focusing on the clinical benefits of catheter-directed treatment, heparin antiocoagulation remains the standard of care for patients with intermediate-high-risk pulmonary embolism (PE). METHODS AND RESULTS: The Higher-Risk Pulmonary Embolism Thrombolysis (HI-PEITHO) study (ClinicalTrials.gov Identifier: NCT04790370) is a multinational multicenter randomized controlled parallel-group comparison trial. Patients with: (1) confirmed acute PE; (2) evidence of right ventricular (RV) dysfunction on imaging; (3) a positive cardiac troponin test; and (4) clinical criteria indicating an elevated risk of early death or imminent hemodynamic collapse, will be randomized 1:1 to treatment with a standardized protocol of ultrasound-facilitated catheter-directed thrombolysis plus anticoagulation, vs anticoagulation alone. The primary outcome is a composite of PE-related mortality, cardiorespiratory decompensation or collapse, or non-fatal symptomatic and objectively confirmed PE recurrence, within 7 days of randomization. Further assessments cover, apart from bleeding complications, a broad spectrum of functional and patient-reported outcomes including quality of life indicators, functional status and the utilization of health care resources over a 12-month follow-up period. The trial plans to include 406 patients, but the adaptive design permits a sample size increase depending on the results of the predefined interim analysis. As of May 11, 2022, 27 subjects have been enrolled. The trial is funded by Boston Scientific Corporation and through collaborative research agreements with University of Mainz and The PERT Consortium. CONCLUSIONS: Regardless of the outcome, HI-PEITHO will establish the first-line treatment in intermediate-high risk PE patients with imminent hemodynamic collapse. The trial is expected to inform international guidelines and set the standard for evaluation of catheter-directed reperfusion options in the future

School Health Programs: Building Capacity through Collaborative Partnerships

GNR Public Health utilized CDC Crisis Response Cooperative Agreement: COVID-19 Public Health Workforce Development supplemental funding to develop and implement a collaborative School Health Program within a local Public Health District. The School Health Program was initially designed to establish, expand, train, and sustain a public health workforce to support jurisdictional COVID-19 prevention, preparedness, response, and recovery initiatives for school-based health programs. Program implementation now also includes non-COVID public health related activities that address needs within the school-aged population. The program was developed in the epidemiology division and is comprised of a registered nurse as program liaison, a school health epidemiologist, a COVID-19 contact tracer, and a data analyst. Focus areas for the team include ongoing COVID-19 response, communicable disease outbreak response, and enhancement of other school health related activities and training capacity. Program services are designed to meet the unique needs of students and families with an emphasis on striving to achieve health equity and considering underserved communities. Program efforts include collaboration with other service areas within the organization such as community health, immunization services, WIC, Children 1st, the Tuberculosis Prevention Program, and the Mobile Engagement Team. The resulting deliverables include direct services such as: participation in community vaccination programs; physical activity and nutrition education for children, parents, and school staff to address chronic disease prevention; participation in school and community health fairs; and provision of training for school nurses and other school staff on topics including Youth Mental Health First Aid, CPR/AED, immunization compliance, scoliosis screening, and infectious disease prevention, mitigation, and reporting. The School Health Program that was developed to respond to the ongoing COVID-19 outbreak has been fully integrated into a highly-functioning, community-driven population health and epidemiology response program serving well over 1.1 million Georgia residents

Effects of Aspartame on Impulsivity as Measured by a Delay-Discounting Procedure

Aspartame is a widely used artificial sweetener; many studies have been conducted to understand its physiological effects. Some of aspartame\u27s effects have shown to be maladaptive, correlated with malignant tumors, leukemia, nephrotoxicity, and an over-excitation of insulin receptors (Charumithrra, et al., 2012). Though studies have assessed the adverse effects of aspartame, few studies have focused on behavioral effects of aspartame, namely impulsive behavior, defined as the selection of a smaller but less delayed reinforcer, over a larger but more delayed reinforcer (e.g., Ainslie, 1974). Impulsivity is commonly assessed using delay-discounting procedures (Mazur, 1987). The artificial sweetener saccharin has been shown to increase impulsivity as measured by delay-discounting tasks (Wilhelm, et al., 2007). Therefore, in the present study we are assessing the effects of aspartame exposure on impulsivity using a delay-discounting procedure. Twenty Sprague Dawley rats were randomly assigned to either an aspartame exposure or a control condition. Rats assigned to the aspartame exposure group are receiving a daily dose of 33mg of aspartame. Rats assigned to the control condition are receiving standard food without aspartame. Rats are currently being tested on the delay-discounting task, whereby a single lever press to one lever leads to delivery of one food pellet immediately, whereas a single lever press a second lever leads to delivery of three food pellets after increasing delay. We expect subjects exposed to aspartame will be more impulsive compared to the control group. Findings hold important implications about how commonly used food additives influence biology and behavior

Lunch Panel - Non-JD\u27s and Their Role in IP Strategy: How These Players are Impacting the Industry

Presented by Northwestern\u27s Master of Science in Law progra

Lunch Panel - Non-JD\u27s and Their Role in IP Strategy: How These Players are Impacting the Industry

Presented by Northwestern\u27s Master of Science in Law progra

9. Role of serum ferritin in dengue and its correlation with disease severity.

Background: Dengue is a self-limited, systemic viral infection transmitted between humans by mosquitoes. The rapidly expanding global footprint of dengue is a public health challenge with an economic burden that is currently unmet by licensed vaccines, specific therapeutic agents, or efficient vector control strategies. The present study is aimed at observing role of raised serum ferritin levels of dengue patients with the disease severity. Aims and Objectives :The present study was conducted to observe role of raised serum ferritin levels of dengue patients with the disease severity. Material and Methods: The present cross sectional study was conducted among 50 dengue patients in Civil hospital Ahmedabad, Gujarat. Laboratory investigations included Ferritin, Packed cell volume, and platelet count. Serum Ferritin was done by kit based Chemiluminescent Micro particle Immunoassay , Packed cell volume and platelet count was done on Fully Automated Hematology Analyzer Horiba ABX Pentra 80. Results: Raised serum ferritin levels were observed in 56% of patients with dengue. Significant association was observed between raised serum ferritin with Packed cell volume and platelets. Conclusion: Present study showed 56% prevalence of raised serum ferritin in dengue patients. High level showed strong correlation with increased Packed cell volume and low platelet levels, clinically reported with hematological symptoms