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Regulatory affairs

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https://www.readbyqxmd.com/read/29933412/exposure-to-multiple-career-pathways-by-biomedical-doctoral-students-at-a-public-research-university
#1
Ambika Mathur, Christine S Chow, Andrew L Feig, Heidi Kenaga, Judith A Moldenhauer, Nisansala S Muthunayake, Mathew L Ouellett, Laura E Pence, Victoria Straub
The Broadening Experiences in Scientific Experiences (BEST) program at Wayne State University was designed to increase doctoral students' awareness of multiple employment sectors beyond academia, improve their knowledge of transferable skills required to succeed in any career path, provide opportunities to explore diverse career paths, and gain in-depth knowledge about those paths using experiential learning opportunities. We devised a three-phase program that ranged from providing students with a broad introduction to multiple career opportunities to immersive experiential learning in a specific career sector...
2018: PloS One
https://www.readbyqxmd.com/read/29914048/-vibrio-species-in-wastewater-final-effluents-and-receiving-watershed-in-south-africa-implications-for-public-health
#2
REVIEW
Allisen N Okeyo, Nolonwabo Nontongana, Taiwo O Fadare, Anthony I Okoh
Wastewater treatment facilities in South Africa are obliged to make provision for wastewater effluent quality management, with the aim of securing the integrity of the surrounding watersheds and environments. The Department of Water Affairs has documented regulatory parameters that have, over the years, served as a guideline for quality monitoring/management purposes. However, these guidelines have not been regularly updated and this may have contributed to some of the water quality anomalies. Studies have shown that promoting the monitoring of the current routinely monitored parameters (both microbial and physicochemical) may not be sufficient...
June 15, 2018: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/29884294/personal-health-records-global-policy-and-regulation-review
#3
REVIEW
Yakov Flaumenhaft, Ofir Ben-Assuli
Personal health records (PHR) have been endorsed as a promising tool for the self-management of an individual's medical information, affording benefits to both the individual patient and the healthcare system as a whole. Nevertheless, adoption rates have been relatively slow and widespread acceptance has yet to be achieved. A significant obstacle often cited as delaying the implementation of these systems has been concern regarding the ability to properly ensure the security and privacy of this sensitive information...
May 14, 2018: Health Policy
https://www.readbyqxmd.com/read/29876456/learning-analytics-dataset-for-empirical-evaluation-of-entry-requirements-into-engineering-undergraduate-programs-in-a-nigerian-university
#4
Jonathan A Odukoya, Segun I Popoola, Aderemi A Atayero, David O Omole, Joke A Badejo, Temitope M John, Olalekan O Olowo
In Nigerian universities, enrolment into any engineering undergraduate program requires that the minimum entry criteria established by the National Universities Commission (NUC) must be satisfied. Candidates seeking admission to study engineering discipline must have reached a predetermined entry age and met the cut-off marks set for Senior School Certificate Examination (SSCE), Unified Tertiary Matriculation Examination (UTME), and the post-UTME screening. However, limited effort has been made to show that these entry requirements eventually guarantee successful academic performance in engineering programs because the data required for such validation are not readily available...
April 2018: Data in Brief
https://www.readbyqxmd.com/read/29868577/an-effective-translation-the-development-of-hyaluronan-based-medical-products-from-the-physicochemical-and-preclinical-aspects
#5
REVIEW
Gloria Huerta-Ángeles, Kristina Nešporová, Gabriela Ambrožová, Lukas Kubala, Vladimir Velebný
This review shows the steps toward material selection focalized on the design and development of medical devices based on hyaluronan (HA). The selection is based on chemical and mechanical properties, biocompatibility, sterilization, safety, and scale-up costs. These facts play a vital role in the industrialization process. Approved medical devices containing-HA are illustrated to identify key parameters. The first part of this work involves the steps toward a complete characterization of chemical and mechanical aspects, reproducibility of the processes and scale up...
2018: Frontiers in Bioengineering and Biotechnology
https://www.readbyqxmd.com/read/29785887/quality-by-design-process-analytical-technology-gmp-and-regulatory-affairs
#6
Metin Çelik
No abstract text is available yet for this article.
July 2018: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/29783113/automated-uhplc-separation-of-10-pharmaceutical-compounds-using-software-modeling
#7
A Zöldhegyi, H-J Rieger, I Molnár, L Fekhretdinova
Human mistakes are still one of the main reasons of underlying regulatory affairs that in a compliance with FDA's Data Integrity and Analytical Quality by Design (AQbD) must be eliminated. To develop smooth, fast and robust methods that are free of human failures, a state-of-the-art automation was presented. For the scope of this study, a commercial software (DryLab) and a model mixture of 10 drugs were subjected to testing. Following AQbD-principles, the best available working point was selected and conformational experimental runs, i...
March 20, 2018: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29782188/an-evaluation-of-nivolumab-for-the-treatment-of-metastatic-renal-cell-carcinoma
#8
Kevin Zarrabi, Shenhong Wu
The treatment paradigm for metastatic renal cell carcinoma (mRCC) has undergone a revolution with the rapid market approval of multiple agents over a three-year period. The immunogenicity of RCC provided the biological rationale to assess the clinical efficacy of nivolumab, an immune checkpoint inhibitor. Nivolumab is approved for second-line treatment after failure of angiogenesis targeted therapy and in combination therapy with ipilimumab for previously untreated intermediate or poor-risk advanced renal cell carcinoma...
May 21, 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29703384/risk-undermined-in-the-bilateral-pharmaceutical-regulatory-system-in-taiwan
#9
REVIEW
Hui-Po Wang, Chun-Li Wang
The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on Harmonization (ICH), addressed an important conceptual change from monitoring the safety of individual medicine to proactively conducting risk prevention for the minimization of medication error. However, the implementation of PVP/RMP is a challenge in societies like Taiwan where irrational medication and co-medication is prevalent. It is even more difficult in Taiwan where two regulatory bodies are governing pharmaceutical affairs, namely Taiwan Food and Drug Administration (TFDA) in charge of Western Medicine (WM) and the Department of Chinese Medicine and Pharmacy (DCMP) in charge of Traditional Chinese Medicine (TCM)...
April 2018: Journal of Food and Drug Analysis
https://www.readbyqxmd.com/read/29384428/telehealth-at-the-us-department-of-veterans-affairs-after-hurricane-sandy
#10
Claudia Der-Martirosian, Anne R Griffin, Karen Chu, Aram Dobalian
Background Like other integrated health systems, the US Department of Veterans Affairs has widely implemented telehealth during the past decade to improve access to care for its patient population. During major crises, the US Department of Veterans Affairs has the potential to transition healthcare delivery from traditional care to telecare. This paper identifies the types of Veterans Affairs telehealth services used during Hurricane Sandy (2012), and examines the patient characteristics of those users. Methods This study conducted both quantitative and qualitative analyses...
January 1, 2018: Journal of Telemedicine and Telecare
https://www.readbyqxmd.com/read/29349812/drug-promotion-practices-a-review
#11
Nilan T Jacob
Over the years, the pharmaceutical industry has been at the forefront of research and innovation in drug discovery and development. The process of drug discovery extending from preclinical studies to multicentric clinical trials and postmarketing phase is a costly affair running into billions of dollars. On the flip side, not all investigational molecules clear the trial phases and get approved, which puts pressure on the manufacturers to maximize the profit from approved drugs. It is in this key area that the practice of drug promotion plays its role...
January 18, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29323613/idrugs-and-idevices-discovery-research-preclinical-assays-techniques-and-animal-model-studies-for-ocular-hypotensives-and-neuroprotectants
#12
Najam A Sharif
Discovery ophthalmic research is centered around delineating the molecular and cellular basis of ocular diseases and finding and exploiting molecular and genetic pathways associated with them. From such studies it is possible to determine suitable intervention points to address the disease process and hopefully to discover therapeutics to treat them. An investigational new drug (IND) filing for a new small-molecule drug, peptide, antibody, genetic treatment, or a device with global health authorities requires a number of preclinical studies to provide necessary safety and efficacy data...
January 2018: Journal of Ocular Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29184849/giving-drugs-a-second-chance-overcoming-regulatory-and-financial-hurdles-in-repurposing-approved-drugs-as-cancer-therapeutics
#13
REVIEW
J Javier Hernandez, Michael Pryszlak, Lindsay Smith, Connor Yanchus, Naheed Kurji, Vijay M Shahani, Steven V Molinski
The repositioning or "repurposing" of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these "new" medicines in oncology...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/29118898/power-to-the-people-data-citizens-in-the-age-of-precision-medicine
#14
Barbara J Evans
Twentieth-century bioethics celebrated individual autonomy but framed autonomy largely in terms of an individual's power to make decisions and act alone. The most pressing challenges of big data science in the twenty-first century can only be resolved through collective action and common purpose. This Article surveys some of these challenges and asks how common purpose can ever emerge on the present bioethical and regulatory landscape. The solution may lie in embracing a broader concept of autonomy that empowers individuals to protect their interests by exercising meaningful rights of data citizenship...
2017: Vanderbilt Journal of Entertainment and Technology Law
https://www.readbyqxmd.com/read/28986035/estimating-the-full-public-health-value-of-vaccination
#15
Bradford D Gessner, David Kaslow, Jacques Louis, Kathleen Neuzil, Katherine L O'Brien, Valentina Picot, Tikki Pang, Umesh D Parashar, Mitra Saadatian-Elahi, Christopher B Nelson
There is an enhanced focus on considering the full public health value (FPHV) of vaccination when setting priorities, making regulatory decisions and establishing implementation policy for public health activities. Historically, a therapeutic paradigm has been applied to the evaluation of prophylactic vaccines and focuses on an individual benefit-risk assessment in prospective and individually-randomized phase III trials to assess safety and efficacy against etiologically-confirmed clinical outcomes. By contrast, a public health paradigm considers the population impact and encompasses measures of community benefits against a range of outcomes...
November 1, 2017: Vaccine
https://www.readbyqxmd.com/read/28966822/neuromind-past-present-and-future
#16
EDITORIAL
Pieter L Kubben
This narrative report describes the underlying rationale and technical developments of NeuroMind, a mobile clinical decision support system for neurosurgery. From the perspective of a neurosurgeon - (app) developer it explains how technical progress has shaped the world's "most rated and highest rated" neurosurgical mobile application, with particular attention for operating system diversity on mobile hardware, cookbook medicine, regulatory affairs (in particular regarding software as a medical device), and new developments in the field of clinical data science, machine learning, and predictive analytics...
2017: Surgical Neurology International
https://www.readbyqxmd.com/read/28946874/design-of-a-single-arm-clinical-trial-of-regenerative-therapy-by-periurethral-injection-of-adipose-derived-regenerative-cells-for-male-stress-urinary-incontinence-in-japan-the-adresu-study-protocol
#17
Shinobu Shimizu, Tokunori Yamamoto, Shinobu Nakayama, Akihiro Hirakawa, Yachiyo Kuwatsuka, Yasuhito Funahashi, Yoshihisa Matsukawa, Keisuke Takanari, Kazuhiro Toriyama, Yuzuru Kamei, Kazutaka Narimoto, Tomonori Yamanishi, Osamu Ishizuka, Masaaki Mizuno, Momokazu Gotoh
BACKGROUND: Male stress urinary incontinence is a prevalent condition after radical prostatectomy. While the standard recommendation for the management of urine leakage is pelvic floor muscle training, its efficacy is still unsatisfactory. Therefore, we have focused on regenerative therapy, which consists of administering a periurethral injection of autologous regenerative cells from adipose tissue, separated using the Celution® system. Based on an interim data analysis of our exploratory study, we confirmed the efficacy and acceptable safety profile of this treatment...
September 25, 2017: BMC Urology
https://www.readbyqxmd.com/read/28944731/the-fda-unapproved-drugs-initiative-an-observational-study-of-the-consequences-for-drug-prices-and-shortages-in-the-united-states
#18
Ravi Gupta, Sanket S Dhruva, Erin R Fox, Joseph S Ross
BACKGROUND: Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28805416/identifying-barriers-to-culture-change-a-qualitative-analysis-of-the-obstacles-to-delivering-resident-centered-care
#19
Ryann L Engle, Denise A Tyler, Katelyn E Gormley, Melissa K Afable, Kimberly Curyto, Omonyêlé L Adjognon, Victoria A Parker, Jennifer L Sullivan
A growing number of healthcare organizations have moved from traditional, institutional nursing home models to ones that emphasize culture change, or resident-centered care (RCC). In 2006, the Department of Veterans Affairs (VA) began implementing a number of changes to VA nursing homes, now called Community Living Centers (CLCs), to provide veterans with a more resident-centered and homelike environment. This study aimed to understand the barriers CLC staff face when delivering RCC. Ten CLCs were included on the basis of their performance levels on RCC and quality of care...
August 2017: Psychological Services
https://www.readbyqxmd.com/read/28772191/synthetic-genetic-circuits-in-crop-plants
#20
REVIEW
Orlando de Lange, Eric Klavins, Jennifer Nemhauser
The love affair between crop breeding and genetics began over a century ago and has continued unabated, from mass selection programs to targeted genome modifications. Synthetic genetic circuits, a recent development, are combinations of regulatory and coding DNA introduced into a crop plant to achieve a desired function. Genetic circuits could accelerate crop improvement, allowing complex traits to be rationally designed and requisite DNA parts delivered directly into a genome of interest. However, there is not yet a standardized pipeline from exploratory laboratory testing to crop trials, and bringing transgenic products to market remains a considerable barrier...
February 2018: Current Opinion in Biotechnology
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