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https://www.readbyqxmd.com/read/29027410/-quality-by-design-approaches-for-pharmaceutical-development-and-manufacturing-of-chinese-medicine
#1
Bing Xu, Xin-Yuan Shi, Zhi-Sheng Wu, Yan-Ling Zhang, Yun Wang, Yan-Jiang Qiao
The pharmaceutical quality was built by design, formed in the manufacturing process and improved during the product's lifecycle. Based on the comprehensive literature review of pharmaceutical quality by design (QbD), the essential ideas and implementation strategies of pharmaceutical QbD were interpreted. Considering the complex nature of Chinese medicine, the "4H" model was innovated and proposed for implementing QbD in pharmaceutical development and industrial manufacture of Chinese medicine product. "4H" corresponds to the acronym of holistic design, holistic information analysis, holistic quality control, and holistic process optimization, which is consistent with the holistic concept of Chinese medicine theory...
March 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29026963/an-evaluation-of-the-role-of-simulation-training-for-teaching-surgical-skills-in-sub-saharan-africa
#2
Nicholas J Campain, Mithun Kailavasan, Mumba Chalwe, Aberra A Gobeze, Getaneh Teferi, Robert Lane, Chandra Shekhar Biyani
BACKGROUND: An estimated 5 billion people worldwide lack access to any surgical care, whilst surgical conditions account for 11-30% of the global burden of disease. Maximizing the effectiveness of surgical training is imperative to improve access to safe and essential surgical care on a global scale. Innovative methods of surgical training have been used in sub-Saharan Africa to attempt to improve the efficiency of training healthcare workers in surgery. Simulation training may have an important role in up-scaling and improving the efficiency of surgical training and has been widely used in SSA...
October 11, 2017: World Journal of Surgery
https://www.readbyqxmd.com/read/29026044/innovative-scattering-analysis-shows-that-hydrophobic-disordered-proteins-are-expanded-in-water
#3
Joshua A Riback, Micayla A Bowman, Adam M Zmyslowski, Catherine R Knoverek, John M Jumper, James R Hinshaw, Emily B Kaye, Karl F Freed, Patricia L Clark, Tobin R Sosnick
A substantial fraction of the proteome is intrinsically disordered, and even well-folded proteins adopt non-native geometries during synthesis, folding, transport, and turnover. Characterization of intrinsically disordered proteins (IDPs) is challenging, in part because of a lack of accurate physical models and the difficulty of interpreting experimental results. We have developed a general method to extract the dimensions and solvent quality (self-interactions) of IDPs from a single small-angle x-ray scattering measurement...
October 13, 2017: Science
https://www.readbyqxmd.com/read/29024353/exercise-and-physical-activity-for-patients-with-esld-improving-functional-status-and-sarcopenia-while-on-the-transplant-waitlist
#4
REVIEW
Andrés Duarte-Rojo, Astrid Ruiz-Margáin, Aldo J Montaño-Loza, Ricardo Macías-Rodríguez, Arny Ferrando, W Ray Kim
Sarcopenia and physical deconditioning are frequent complications in patients with cirrhosis and end-stage liver disease (ESLD). They are the end result of impaired dietary intake, chronic inflammation, altered macro- and micronutrient metabolism, and low physical activity. Frailty is the end result of prolonged sarcopenia and physical deconditioning. It severely affects a patient's functional status, and presents in about 1 in 5 patients on the liver transplant (LT) waitlist. Sarcopenia, poor physical fitness/cardiopulmonary endurance, and frailty are all associated with increased mortality in ESLD...
October 11, 2017: Liver Transplantation
https://www.readbyqxmd.com/read/29024333/united-we-stand-divided-we-conquer-pilot-study-of-multidisciplinary-general-medicine-heart-failure-care-program
#5
Omar Wahbi Izzettin, Ingrid Hopper, Edward Ritchie, Vathy Nagalingam, Ar Kar Aung
BACKGROUND: Heart failure care and education require a multifaceted approach to ensure appropriate transition from inpatient to outpatient care. AIMS: To explore the feasibility of a multidisciplinary heart failure care model, General Medicine Heart Failure Care Program (GM-HFCP) within a General Medical Unit (GMU). METHODS: Prospective non-randomised before-and-after observational quality improvement intervention over a 6-month period. All consecutive patients admitted to GMU at Alfred Hospital with diagnosis of acute decompensated heart failure were included...
October 11, 2017: Internal Medicine Journal
https://www.readbyqxmd.com/read/29024265/effectiveness-of-a-handmade-new-carotid-catheter-in-transradial-carotid-angiography-a-comparison-with-conventional-multipurpose-catheters
#6
Yakup Balaban
OBJECTIVE: The incidence and severity of carotid atherosclerosis increases in proportion with coronary artery disease and its severity. A special catheter specifically used for transradial carotid angiography has not yet been marketed. In this study, we investigate the feasibility and safety of our carotid catheter, which was made by reshaping currently available catheters. METHODS: Between 2010 and 2017, a total of 921 patients with indications for carotid angiography were identified after angiographic examinations and included in the study...
October 11, 2017: Journal of Interventional Cardiology
https://www.readbyqxmd.com/read/29023446/towards-elimination-of-visceral-leishmaniasis-in-the-indian-subcontinent-translating-research-to-practice-to-public-health
#7
REVIEW
Siddhivinayak Hirve, Axel Kroeger, Greg Matlashewski, Dinesh Mondal, Megha Raj Banjara, Pradeep Das, Ahmed Be-Nazir, Byron Arana, Piero Olliaro
BACKGROUND: The decade following the Regional Strategic Framework for Visceral Leishmaniasis (VL) elimination in 2005 has shown compelling progress in the reduction of VL burden in the Indian subcontinent. The Special Programme for Research and Training in Tropical Diseases (TDR), hosted by the World Health Organization (WHO) and other stakeholders, has coordinated and financed research for the development of new innovative tools and strategies to support the regional VL elimination initiative...
October 2017: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/29022167/stochastic-evaluation-of-annual-micropollutant-loads-and-their-uncertainties-in-separate-storm-sewers
#8
Ali Hannouche, Ghassan Chebbo, Claude Joannis, Johnny Gasperi, Marie-Christine Gromaire, Régis Moilleron, Sylvie Barraud, Véronique Ruban
This article describes a stochastic method to calculate the annual pollutant loads and its application over several years at the outlet of three catchments drained by separate storm sewers. A stochastic methodology using Monte Carlo simulations is proposed for assessing annual pollutant load, as well as the associated uncertainties, from a few event sampling campaigns and/or continuous turbidity measurements (representative of the total suspended solids concentration (TSS)). Indeed, in the latter case, the proposed method takes into account the correlation between pollutants and TSS...
October 11, 2017: Environmental Science and Pollution Research International
https://www.readbyqxmd.com/read/29021110/collaborative-care-from-the-emergency-department-for-injured-patients-with-prescription-drug-misuse-an-open-feasibility-study
#9
Lauren K Whiteside, Doyanne Darnell, Karlee Jackson, Jin Wang, Joan Russo, Dennis M Donovan, Douglas F Zatzick
Collaborative Care is a comprehensive longitudinal care management strategy. The purpose of this pilot effectiveness-implementation hybrid study was to determine the feasibility of a Collaborative Care intervention initiated from the Emergency Department and proceeding longitudinally for six months for injured patients with prescription drug misuse (PDM). Adult patients presenting to an urban ED with an injury were screened for eligibility from 2/2015-8/2015. Eligible participants with a positive screen for PDM were enrolled in the 'ED-LINC' intervention which included the following elements: 1) active care coordination and linkage, 2) medication safety and utilization of opioid guidelines 3) longitudinal care management and 4) utilization of Electronic Medical Record (EMR) innovations such as the statewide Emergency Department Information Exchange (EDIE) and statewide prescription monitoring program information for assessment and follow-up...
November 2017: Journal of Substance Abuse Treatment
https://www.readbyqxmd.com/read/29020508/variability-of-intended-copies-for-etanercept-enbrel%C3%A2-data-on-multiple-batches-of-seven-products
#10
Brian Hassett, Morton Scheinberg, Gilberto Castañeda-Hernández, Mengtao Li, Uppuluri Rk Rao, Ena Singh, Ehab Mahgoub, Javier Coindreau, Julie O'Brien, Steven M Vicik, Brian Fitzpatrick
Fusion protein and monoclonal antibody-based tumor necrosis factor (TNF) inhibitors represent established treatment options for a range of inflammatory diseases. Regulatory authorities have outlined the structural characterization and clinical assessments necessary to establish biosimilarity of a new biotherapeutic product with the innovator biologic drug. Biologic products that would not meet the minimum World Health Organization's standard for evaluation of similar biotherapeutic products are available in some countries; in some cases relevant data to assess biosimilarity and appropriate regulatory approval pathways are lacking...
October 11, 2017: MAbs
https://www.readbyqxmd.com/read/29020417/the-reducer-device-in-patients-with-angina-pectoris-mechanisms-indications-and-perspectives
#11
Maayan Konigstein, Francesco Giannini, Shmuel Banai
Despite available pharmacological and interventional therapies, refractory angina is a common and disabling clinical condition, and a major public health problem, which affects patients' quality-of-life, and has a significant impact upon health care resources. Persistent angina is common not only in patients who are not good candidates for revascularization, but also in patients following successful revascularization. Clearly, there is a need for additional treatment options for refractory angina beyond currently available pharmacological and interventional therapies...
August 31, 2017: European Heart Journal
https://www.readbyqxmd.com/read/29016166/-replicability-and-other-features-of-a-high-quality-science-toward-a-balanced-and-empirical-approach-correction-to-finkel-et-al-2017
#12
(no author information available yet)
Reports an error in "Replicability and other features of a high-quality science: Toward a balanced and empirical approach" by Eli J. Finkel, Paul W. Eastwick and Harry T. Reis (Journal of Personality and Social Psychology, 2017[Aug], Vol 113[2], 244-253). In the commentary, there was an error in the References list. The publishing year for the 18th article was cited incorrectly as 2016. The in-text acronym associated with this citation should read instead as LCL2017. The correct References list citation should read as follows: LeBel, E...
November 2017: Journal of Personality and Social Psychology
https://www.readbyqxmd.com/read/28994525/-discussion-on-efficacy-evaluation-thought-and-method-for-innovation-medicine-of-chinese-herbal-compound-formula-based-on-clinical-application-characteristics
#13
Jian-Ning Sun, Wen-Yan Sun, Shi-Fen Dong
The Chinese herbal compound formula preparation was made based on theory of Chinese medicine, which was confirmed by long period clinical application, and with multi-compound and multi-target characteristics. During the exploitation process of innovation medicine of Chinese herbal compound formula, selecting and speeding up the research development of drugs with clinical value shall be paid more attention, and as request of rules involved in new drug research and development, the whole process management should be carried out, including project evaluation, manufacturing process determination, establishment of quality control standards, evaluation for pharmacological and toxic effect, as well as new drug application process...
March 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/28994197/in-vino-veritas-an-invitation-for-ambitious-collaborative-proteogenomics-campaigns-on-plant-and-animal-models
#14
Jean Armengaud
Vitis vinifera has been an emblematic plant for Humans since the Neolithic period. Human civilization has been shaped by its domestication as both its medicinal and nutritional values were exploited. It is now cultivated on all habitable continents, and more than 5 thousand varieties have been developed. A global passion for the art of wine fuels innovation and a profound desire for knowledge on this plant. The genome sequence of a homozygotic cultivar and several RNA-seq datasets on other varieties have been released paving the way to gaining further insight into its biology and tailoring improvements to varieties...
October 10, 2017: Proteomics
https://www.readbyqxmd.com/read/28993834/ipsc-derived-neural-precursor-cells-potential-for-cell-transplantation-therapy-in-spinal-cord-injury
#15
REVIEW
Narihito Nagoshi, Hideyuki Okano
A number of studies have demonstrated that transplantation of neural precursor cells (NPCs) promotes functional recovery after spinal cord injury (SCI). However, the NPCs had been mostly harvested from embryonic stem cells or fetal tissue, raising the ethical concern. Yamanaka and his colleagues established induced pluripotent stem cells (iPSCs) which could be generated from somatic cells, and this innovative development has made rapid progression in the field of SCI regeneration. We and other groups succeeded in producing NPCs from iPSCs, and demonstrated beneficial effects after transplantation for animal models of SCI...
October 9, 2017: Cellular and Molecular Life Sciences: CMLS
https://www.readbyqxmd.com/read/28993721/team-clinic-an-innovative-group-care-model-for-youth-with-type-1-diabetes-engaging-patients-and-meeting-educational-needs
#16
Cari Berget, Jennifer Lindwall, Jacqueline J Shea, Georgeanna J Klingensmith, Barbara J Anderson, Cindy Cain, Jennifer K Raymond
The purpose of this pilot was to implement an innovative group care model, "Team Clinic", for adolescents with type 1 diabetes and assess patient and provider perspectives. Ninety-one intervention patients and 87 controls were enrolled. Ninety-six percent of intervention adolescents endorsed increased support and perceived connecting with peers as important. The medical providers and staff also provided positive feedback stating Team Clinic allowed more creativity in education and higher quality of care. Team Clinic may be a promising model to engage adolescents and incorporate education and support into clinic visits in a format valued by patients and providers...
June 2017: Journal for Nurse Practitioners: JNP
https://www.readbyqxmd.com/read/28993389/innovative-telemonitoring-enhanced-care-programme-for-chronic-heart-failure-itec-chf-to-improve-guideline-compliance-and-collaborative-care-protocol-of-a-multicentre-randomised-controlled-trial
#17
Hang Ding, Rajiv Jayasena, Andrew Maiorana, Alison Dowling, Sheau Huey Chen, Mohan Karunanithi, Jamie Layland, Iain Edwards
INTRODUCTION: Chronic heart failure (CHF) is a life-threatening chronic disease characterised by periodic exacerbations and recurrent hospitalisations. In the management of CHF, patient compliance with evidence-based clinical guidelines is essential, but remains difficult practically. The objective of this study is to examine whether an Innovative Telemonitoring Enhanced Care Programme for CHF (ITEC-CHF) improves patients' compliance, and associated health and economic outcomes. METHODS AND ANALYSIS: An open multicentre randomised controlled trial has been designed...
October 8, 2017: BMJ Open
https://www.readbyqxmd.com/read/28993075/call-to-action-aprns-in-u-s-nursing-homes-to-improve-care-and-reduce-costs
#18
Marilyn J Rantz, Nancy M Birtley, Marcia Flesner, Charles Crecelius, Cathy Murray
BACKGROUND: Centers for Medicare and Medicaid Innovation Center sponsored the initiative to reduce avoidable hospitalizations among nursing facility residents. PURPOSE: Missouri Quality Initiative (MOQI) designed inter-professional model in nursing homes with advanced practice registered nurses (APRNs). METHOD: MOQI APRN model was implemented for 4 years in 16 nursing homes in a metro area of the Midwest. Hospitalizations were reduced (40% all-cause, 58% potentially avoidable), emergency room visits (54% all-cause, 65% potentially avoidable), Medicare expenditures for hospitalizations (34% all-cause, 45% potentially avoidable), and Medicare expenditures for emergency room visits (50% all-cause, 60% potentially avoidable) for long-stay nursing home residents...
September 21, 2017: Nursing Outlook
https://www.readbyqxmd.com/read/28990858/quantitative-analysis-of-user-interfaces-for-large-electronic-home-appliances-and-mobile-devices-based-on-lifestyle-categorization-of-older-users
#19
Wonkyoung Shin, Minyong Park
Background/Study Context: The increasing longevity and health of older users as well as aging populations has created the need to develop senior-oriented product interfaces. This study aims to find user interface (UI) priorities according to older user groups based on their lifestyle and develop quality of UI (QUI) models for large electronic home appliances and mobile products. METHODS: A segmentation table designed to show how older users can be categorized was created through a review of the literature to survey 252 subjects with a questionnaire...
October 9, 2017: Experimental Aging Research
https://www.readbyqxmd.com/read/28988359/patient-reported-outcomes-after-sacrospinous-fixation-of-vault-prolapse-with-a-suturing-device-a-retrospective-national-cohort-study
#20
Jennifer Campbell, Corinne Pedroletti, Linn Ekhed, Emil Nüssler, Annika Strandell
INTRODUCTION AND HYPOTHESIS: Innovations in suturing devices have facilitated sacrospinous ligament fixation (SSF) for the correction of vaginal vault prolapse. It is uncertain if outcomes using suturing devices differ from those using a traditional suturing technique. We hypothesize that no difference exists in the efficacy and safety 1 year after SSF for vault prolapse performed with suturing devices or using a traditional technique. The objective was to compare SSF using a suturing device with traditional SSF for the treatment of vault prolapse, regarding symptoms of prolapse recurrence, patient satisfaction, incidence of re-operation, and complications 1 year postoperatively...
October 7, 2017: International Urogynecology Journal
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