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https://www.readbyqxmd.com/read/29241294/early-stage-formulation-considerations
#1
Robert W Lee, Mark Mitchnick
When a drug candidate-i.e., a new chemical entity (NCE) or new molecular entity (NME)-is discovered, there is a requirement to identify a vehicle for in vitro and/or in vivo evaluation to assess the activity and/or toxicity of the compound (here we refer to the biologically active compound as the active pharmaceutical ingredient: API). Ideally, this vehicle will not impart any biological activity or any toxicity that would mask or confound the effects of the API. At this early stage in development, and given the high attrition rates of drug candidates in discovery, it does not make sense to fully characterize the API-speed and cost are generally the driving factors...
December 14, 2017: Current Protocols in Chemical Biology
https://www.readbyqxmd.com/read/29241087/development-of-a-fast-hplc-dad-method-for-simultaneous-quantitation-of-three-immunosuppressant-drugs-in-whole-blood-samples-using-intelligent-chemometrics-resolving-of-coeluting-peaks-in-the-presence-of-blood-interferences
#2
Maryam Vosough, Sadaf Mosleh Tehrani
The present study describes a fast high performance liquid chromatography-diode array detection analytical methodology for quantification of tacrolimus, everolimus and cyclosporine A in whole blood samples, with minimum sample preparation steps. A short isocratic chromatographic elution was coupled with second-order calibration using multivariate curve resolution to stablish a smart and green methodology. Due to presence of matrix effect, a sample-added calibration strategy was used for quantification purposes...
December 9, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/29241083/a-review-of-the-value-of-human-epidermal-growth-factor-receptor-2-her2-targeted-therapies-in-breast-cancer
#3
REVIEW
N A Nixon, M B Hannouf, S Verma
The cost of cancer drugs continues to escalate with the rapid development and approval of novel therapies, especially over the course of the last decade. In human epidermal growth factor receptor 2 (HER2)-positive breast cancer, the survival benefits gained by new treatments have been undeniably substantial. It is important to assess the financial value of these therapies for decision making at both the societal and individual level. This information is key for managing resources in resource-limited health care systems, while at the same time supporting patient decision-making and conversations between patient and physicians on cost versus benefit...
December 10, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/29241014/an-observational-study-of-the-efficacy-of-cisatracurium-compared-to-vecuronium-in-patients-with-or-at-risk-for-ards
#4
Peter D Sottile, Tyree H Kiser, Ellen L Burnham, P Michael Ho, Richard R Allen, R William Vandivier, Marc Moss
RATIONALE: The neuromuscular blocking agent cisatracurium may improve mortality for patients with moderate-severe ARDS. Other neuromuscular blocking agents, such as vecuronium, are commonly used and have different mechanisms of action, side effects, cost, and availability in the setting of drug shortages. OBJECTIVE: To determine whether cisatracurium is associated with improved outcomes when compared vecuronium in patients at risk for and with ARDS. METHODS: Using a nationally representative database, patients admitted to the intensive care unit (ICU) with a diagnosis of ARDS or an ARDS risk factor, received mechanical ventilation, and were treated with a continuous infusion of neuromuscular blocking agent for at least two days within two days of hospital admission were included...
December 14, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/29240864/patient-awareness-of-local-drug-price-variation-and-the-factors-that-influence-pharmacy-choice-a-cross-sectional-survey-study
#5
Spencer D Brodsky, Olabola D Awosika, Misty G Eleryan, Monica Rengifo-Pardo, Xiangyu Kuang, Richard L Amdur, Alison Ehrlich
<p>Background: High out-of-pocket drug expenditures are increasingly common in dermatology. Patients may not be aware that prices vary among pharmacies and consequently may not shop for the lowest cost.</p> <p>Objective: To determine what factors influence pharmacy choice and the effect of providing local prescription prices on pharmacy selection. We hypothesized that patients do not "shop around" due to lack of knowledge of price variation and would choose a pharmacy based on costs if educated on price disparity...
December 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/29240860/cost-per-additional-responder-associated-with-ixekizumab-and-etanercept-in-the-treatment-of-moderate-to-severe-psoriasis
#6
Steven R Feldman, Shonda A Foster, Baojin Zhu, Russel Burge, Sarah Al Sawah, Orin M Goldblum
<p>BACKGROUND: Newer psoriasis treatments can achieve greater levels of effcacy than older systemic therapies; however, current pso-riasis costs are substantial. We sought to estimate costs per additional responder associated with ixekizumab and etanercept, versus placebo, using effcacy data from phase 3 clinical trials (UNCOVER-2 and UNCOVER-3).</p> <p>METHODS: In UNCOVER-2/UNCOVER-3, patients received subcutaneous placebo, etanercept 50 mg twice weekly (BIW), or ixekizumab one 80 mg injection every 2 weeks (Q2W) after a 160-mg starting dose...
December 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/29240798/the-cost-of-comorbidities-in-treatment-for-hiv-aids-in-california
#7
David S Zingmond, Kodi B Arfer, Jennifer L Gildner, Arleen A Leibowitz
BACKGROUND: Antiretroviral therapy has increased longevity for people living with HIV (PLWH). As a result, PLWH increasingly experience the common diseases of aging and the resources needed to manage these comorbidities are increasing. This paper characterizes the number and types of comorbidities diagnosed among PLWH covered by Medicare and examines how non-HIV comorbidities relate to outpatient, inpatient, and pharmaceutical expenditures. METHODS: The study examined Medicare expenditures for 9767 HIV-positive Californians enrolled in Medicare in 2010 (7208 persons dually covered by Medicare and Medicaid and 2559 with Medicare only)...
2017: PloS One
https://www.readbyqxmd.com/read/29240409/from-experiments-to-a-fast-easy-to-use-computational-methodology-to-predict-human-aldehyde-oxidase-selectivity-and-metabolic-reactions
#8
Gabriele Cruciani, Nicolò Milani, Paolo Benedetti, Susan Lepri, Lucia Cesarini, Massimo Baroni, Francesca Spyrakis, Sara Tortorella, Edoardo Mosconi, Laura Goracci
Aldehyde oxidase (AOX) is a molibdo-flavoenzyme that raised great interest in recent years, since its contribution in xenobiotics metabolism has not always been identified before clinical trials, with consequent negative effects on the fate of new potential drugs. The fundamental role of AOX in metabolizing xenobiotics is also due to the attempt of medicinal chemists to stabilize candidates toward cytochrome P450 activity, which increases the risk for new compounds to be susceptible to AOX nucleophile attack...
December 14, 2017: Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/29240313/deconvolution-of-images-from-3d-printed-cells-in-layers-on-a-chip
#9
Sean Yu, Pranav Joshi, Yi Ju Park, Kyeong-Nam Yu, Moo-Yeal Lee
Layer-by-layer cell printing is useful in mimicking layered tissue structures inside the human body and has great potential for being a promising tool in the field of tissue engineering, regenerative medicine, and drug discovery. However, imaging human cells cultured in multiple hydrogel layers in 3D-printed tissue constructs is challenging as the cells are not in a single focal plane. Although confocal microscopy could be a potential solution for this issue, it compromises the throughput which is a key factor in rapidly screening drug efficacy and toxicity in pharmaceutical industries...
December 14, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/29239621/a-qualitative-analysis-of-gabapentin-misuse-and-diversion-among-people-who-use-drugs-in-appalachian-kentucky
#10
Rachel Vickers Smith, Elaine M Boland, April M Young, Michelle R Lofwall, Alexa Quiroz, Michele Staton, Jennifer R Havens
Gabapentin, an anticonvulsant and analgesic for postherpetic neuralgia, has been thought to have no abuse potential despite numerous published reports to the contrary. Gabapentin has been linked with impaired driving and opioid use, highlighting the need to more fully understand its risk profile. Thirty-three individuals reporting recent nonmedical use of gabapentin were recruited from two ongoing longitudinal studies of drug users in Appalachian Kentucky to participate in focus groups. Four sessions were held (two in the community and two in jail settings), during which participants responded to questions regarding their personal experiences with gabapentin misuse...
December 14, 2017: Psychology of Addictive Behaviors: Journal of the Society of Psychologists in Addictive Behaviors
https://www.readbyqxmd.com/read/29239200/digital-health-and-perioperative-care
#11
Theofanis Fotis
According to the U.S. Food and Drug Administration 'the broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalised medicine, and is used by providers and other stakeholders in their efforts to reduce inefficiencies, improve access, reduce costs, increase quality, and make medicine more personalised for patients (FDA 2016). More recently, Paul Sonier, a digital health strategist and founder of the Linkedin digital health group with more than 40,000 members, defined digital health as 'the convergence of the digital and genomic revolutions with health, healthcare, living, and society' (storyofdigitalhealth...
June 2017: Journal of Perioperative Practice
https://www.readbyqxmd.com/read/29239194/-immunotherapy-of-renal-cell-carcinoma
#12
A Poprach, R Lakomý, T Büchler
Treatment of renal cell carcinoma is still palliative. Targeted therapy increases response rates and prolongs overall survival and progression-free survival compared with cytokines and chemotherapy. Checkpoint inhibitors constitute the up-date of therapeutic approaches, and anti-PD-1 antibody, one checkpoint inhibitor, is now well established as a second and/or third palliative treatment for patients with renal cell carcinoma. In this study, we present the latest data from current studies on cytokines, cancer vaccines, ipilimumab, and nivolumab...
2017: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
https://www.readbyqxmd.com/read/29238707/drug-repurposing-for-the-treatment-of-acute-myeloid-leukemia
#13
REVIEW
Vibeke Andresen, Bjørn T Gjertsen
Acute myeloid leukemia (AML) is a heterogeneous disease characterized by the accumulation of immature myeloid progenitor cells in the bone marrow, compromising of normal blood cell production and ultimately resulting in bone marrow failure. With a 20% overall survival rate at 5 years and 50% in the 18- to 65-year-old age group, new medicines are needed. It is proposed that development of repurposed drugs may be a part of the new therapy needed. AML is subdivided into recurrent molecular entities based on molecular genetics increasingly accessible for precision medicine...
2017: Frontiers in Medicine
https://www.readbyqxmd.com/read/29238237/adolescent-pre-exposure-prophylaxis-for-hiv-prevention-current-perspectives
#14
REVIEW
Daisy Maria Machado, Alexandre Machado de Sant'Anna Carvalho, Rachel Riera
Adolescents are a critical population that is disproportionately impacted by the HIV epidemic. More than 2 million adolescents between the age group of 10 and 19 years are living with HIV, and millions are at risk of infection. HIV risks are considerably higher among girls, especially in high-prevalence settings such as eastern and southern Africa. In addition to girls, there are other vulnerable adolescent subgroups, such as teenagers, who use intravenous (IV) drugs, gay and bisexual boys, transgender youth, male sex workers, and people who fall into more than one of these categories...
2017: Adolescent Health, Medicine and Therapeutics
https://www.readbyqxmd.com/read/29238210/biological-therapy-utilization-switching-and-cost-among-patients-with-psoriasis-retrospective-analysis-of-administrative-databases-in-southern-italy
#15
Francesca Guerriero, Valentina Orlando, Valeria Marina Monetti, Veronica Russo, Enrica Menditto
Purpose: The aim was to describe the current use of biological therapies among patients affected by psoriasis and to analyze a drug utilization profile in naïve patients in terms of switching and treatment costs in a Local Health Unit (LHU) of Southern Italy. Methods: We conducted an observational retrospective cohort analysis using the health-related administrative databases of a LHU in Southern Italy covering a population of about one million inhabitants. All subjects with a main or secondary diagnosis of psoriasis who received at least one prescription of biological therapies between January 1, 2010 and December 31, 2014 were analyzed...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/29237491/cost-effectiveness-of-enzyme-replacement-therapy-with-alglucosidase-alfa-in-adult-patients-with-pompe-disease
#16
Tim A Kanters, Ans T van der Ploeg, Michelle E Kruijshaar, Dimitris Rizopoulos, W Ken Redekop, Maureen P M H Rutten-van Mӧlken, Leona Hakkaart-van Roijen
BACKGROUND: Pompe disease is a rare, progressive, metabolic disease, and the first treatable inheritable muscle disorder. Enzyme replacement therapy (ERT) with alglucosidase alfa is disease specific and the only medicinal product authorized for the treatment of Pompe disease. Costs of ERT are very high as for most orphan drugs. This study investigates the cost-effectiveness of ERT compared to supportive treatment in adult patients with Pompe disease. METHODS: Survival probabilities were estimated from an international observational dataset (n = 283) using a time-dependent Cox model...
December 13, 2017: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/29237206/-piperacillin-tazobactam-shortage-central-restriction-and-alternative-recommendations-as-effective-antibiotic-stewardship-intervention-at-a-maximal-care-hospital
#17
Johanna Kessel, Barbara Dolff, Thomas Wichelhaus, Nils Keiner, Michael Hogardt, Claudia Reinheimer, Imke Wieters, Sebastian Harder, Volkhard A J Kempf, Christoph Stephan
Background Drug supply bottleneck is a worldwide challenge, e. g. the antibiotics Piperacillin/Tazobactam shortage in 2016/2017. The efficacy of an appropriate replacement management was evaluated at the University Hospital Frankfurt (UHF). Methods The Antibiotic-Stewardship (ABS)-Team at UHF decreed a restriction of PIP/TAZ and provided alternative antibiotic therapy recommendations during the shortage period. Consequences of this intervention on antibiotic consumption and overall costs were investigated...
December 13, 2017: Deutsche Medizinische Wochenschrift
https://www.readbyqxmd.com/read/29236682/is-it-beneficial-to-reuse-the-balloon-in-percutaneous-kyphoplasty-for-the-treatment-of-non-neoplastic-vertebral-compression-fractures
#18
Zehao Jing, Qi Sun, Jianli Dong, Fanqi Meng, Youzhi Song, Tonglin Xia, Jia Luo, Yanqiang Li, Feng Nan
BACKGROUND Percutaneous kyphoplasty (PKP) has been widely used to treat vertebral compression fractures (VCFs). Bilateral percutaneous punctures are always performed to access the fractured vertebrae. However, the procedure has expensive clinical costs, especially the cost for the device, which creates a heavy financial burden for patients. MATERIAL AND METHODS Data from 49 patients who have single-level non-neoplastic vertebral compression fracture (VCF) were collected for 12 months after treated by PKP, including 21 cases that used bilateral puncture with single balloon (S group) and 28 cases that used bilateral puncture with double balloon (D group)...
December 13, 2017: Medical Science Monitor: International Medical Journal of Experimental and Clinical Research
https://www.readbyqxmd.com/read/29236624/a-socio-ecological-examination-of-treatment-access-uptake-and-adherence-issues-encountered-by-hiv-positive-women-in-rural-north-central-nigeria
#19
Llewellyn J Cornelius, Salome C Erekaha, Joshua N Okundaye, Nadia A Sam-Agudu
BACKGROUND: In spite of the global decline in HIV infections, sub-Saharan Africa still accounts for a non-proportional majority of global new infections. While many studies have documented the importance of facilitating access to anti-retroviral therapy (ART) as a means of reducing infections, the relationship between interpersonal, community, healthcare facility, and policy-level factors and treatment adherence in Africa have not been well-described. The authors examined these factors in the context of prevention of mother-to-child transmission (PMTCT) of HIV in rural north-central Nigeria, where HIV burden is high and service coverage is low...
December 13, 2017: Journal of Evidence-informed Social Work
https://www.readbyqxmd.com/read/29236427/sharing-samples-and-generics-an-antitrust-framework
#20
Michael A Carrier
Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition...
2017: Cornell Law Review
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