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https://www.readbyqxmd.com/read/28093972/conformation-as-the-therapeutic-target-for-neurodegenerative-diseases
#1
Rajaraman Krishnan, Franz Hefti, Haim Tsubery, Michal Lulu, Ming Proschitsky, Richard Fisher
Therapeutic strategies that target pathways of protein misfolding and the toxicity of intermediates along these pathways are mainly at discovery and early development stages, with the exception of monoclonal antibodies that have mainly failed to produce convincing clinical benefits in late stage trials. The clinical failures represent potentially critical lessons for future neurodegenerative disease drug development. More effective drugs may be achieved by pursuing the following two strategies. First, conformational targeting of aggregates of misfolded proteins, rather than less specific binding that includes monomer subunits, which vastly outnumber the toxic targets...
January 16, 2017: Current Alzheimer Research
https://www.readbyqxmd.com/read/28092856/separation-of-antibody-drug-conjugate-species-by-rplc-a-generic-method-development-approach
#2
Szabolcs Fekete, Imre Molnár, Davy Guillarme
This study reports the use of modelling software for the successful method development of IgG1 cysteine conjugated antibody drug conjugate (ADC) in RPLC. The goal of such a method is to be able to calculate the average drug to antibody ratio (DAR) of and ADC product. A generic method development strategy was proposed including the optimization of mobile phase temperature, gradient profile and mobile phase ternary composition. For the first time, a 3D retention modelling was presented for large therapeutic protein...
January 11, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28090798/switching-from-branded-to-generic-glatiramer-acetate-15-month-gate-trial-extension-results
#3
Krzysztof Selmaj, Frederik Barkhof, Anna N Belova, Christian Wolf, Evelyn Rw van den Tweel, Janine Jl Oberyé, Roel Mulder, David F Egging, Norbert P Koper, Jeffrey A Cohen
BACKGROUND: Open-label 15-month follow-up of the double-blind, placebo-controlled Glatiramer Acetate clinical Trial to assess Equivalence with Copaxone(®) (GATE) trial. OBJECTIVE: To evaluate efficacy, safety, and tolerability of prolonged generic glatiramer acetate (GTR) treatment and to evaluate efficacy, safety, and tolerability of switching from brand glatiramer acetate (GA) to GTR treatment. METHODS: A total of 729 patients received GTR 20 mg/mL daily...
January 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28088695/deep-metabolome-annotation-in-natural-products-research-towards-a-virtuous-cycle-in-metabolite-identification
#4
REVIEW
Pierre-Marie Allard, Grégory Genta-Jouve, Jean-Luc Wolfender
Natural products (NPs) research is changing and rapidly adopting cutting-edge tools, which radically transform the way to characterize extracts and small molecules. With the innovations in metabolomics, early integration of deep metabolome annotation information allows to efficiently guide the isolation of valuable NPs only and, in parallel, to generate massive metadata sets for the study of given extracts under various perspectives. This is the case for chemotaxonomy studies where common biosynthetic traits among species can be evidenced, but also for drug discovery purpose where such traits, in combination with bioactivity studies on extracts, may evidence bioactive molecules even before their isolation...
January 12, 2017: Current Opinion in Chemical Biology
https://www.readbyqxmd.com/read/28086866/perceptions-and-utilization-of-generic-medicines-in-guatemala-a-mixed-methods-study-with-physicians-and-pharmacy-staff
#5
David Flood, Irène Mathieu, Anita Chary, Pablo García, Peter Rohloff
BACKGROUND: Access to low-cost essential generic medicines is a critical health policy goal in low-and-middle income countries (LMICs). Guatemala is an LMIC where there is both limited availability and affordability of these medications. However, attitudes of physicians and pharmacy staff regarding low-cost generics, especially generics for non-communicable diseases (NCDs), have not been fully explored in Guatemala. METHODS: Semi-structured interviews with 30 pharmacy staff and 12 physicians in several highland towns in Guatemala were conducted...
January 13, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28081041/a-systematic-literature-review-approach-to-estimate-the-therapeutic-index-of-selected-immunosuppressant-drugs-after-renal-transplantation
#6
Jessica E Ericson, Kanecia O Zimmerman, Daniel Gonzalez, Chiara Melloni, Jeffrey T Guptill, Kevin D Hill, Huali Wu, Michael Cohen-Wolkowiez
BACKGROUND: Drugs that exhibit close margins between therapeutic and toxic blood concentrations are considered to have a narrow therapeutic index (NTI). The Food and Drug Administration has proposed that NTI drugs should have more stringent bioequivalence standards for approval of generic formulations. However, many immunosuppressant drugs do not have a well-defined therapeutic index (TI). METHODS: We sought to determine whether safety, efficacy, and pharmacokinetic data obtained from the medical literature through a comprehensive literature search could be used to estimate the TI of cyclosporine, tacrolimus, and sirolimus...
February 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28080991/minimizing-fungal-disease-deaths-will-allow-the-unaids-target-of-reducing-annual-aids-deaths-below-500-000-by-2020-to-be-realized
#7
REVIEW
David W Denning
Deaths from AIDS (1 500 000 in 2013) have been falling more slowly than anticipated with improved access to antiretroviral therapy. Opportunistic infections account for most AIDS-related mortality, with a median age of death in the mid-30s. About 360 000 (24%) of AIDS deaths are attributed to tuberculosis. Fungal infections deaths in AIDS were estimated at more than 700 000 deaths (47%) annually. Rapid diagnostic tools and antifungal agents are available for these diseases and would likely have a major impact in reducing deaths...
December 5, 2016: Philosophical Transactions of the Royal Society of London. Series B, Biological Sciences
https://www.readbyqxmd.com/read/28073970/estimated-generic-prices-for-novel-treatments-for-drug-resistant-tuberculosis
#8
Dzintars Gotham, Joseph Fortunak, Anton Pozniak, Saye Khoo, Graham Cooke, Frederick E Nytko, Andrew Hill
BACKGROUND: The estimated worldwide annual incidence of MDR-TB is 480 000, representing 5% of TB incidence, but 20% of mortality. Multiple drugs have recently been developed or repurposed for the treatment of MDR-TB. Currently, treatment for MDR-TB costs thousands of dollars per course. OBJECTIVES: To estimate generic prices for novel TB drugs that would be achievable given large-scale competitive manufacture. METHODS: Prices for linezolid, moxifloxacin and clofazimine were estimated based on per-kilogram prices of the active pharmaceutical ingredient (API)...
January 10, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28068463/long-term-acute-phase-treatment-with-antidepressants-8-weeks-and-beyond-a-systematic-review-and-meta-analysis-of-randomized-placebo-controlled-trials
#9
Jonathan Henssler, Mona Kurschus, Jeremy Franklin, Tom Bschor, Christopher Baethge
OBJECTIVE: In clinical practice, acute antidepressant treatment is often applied for several months until remission is achieved. However, data on treatment outcomes beyond 8 weeks are sparse and no systematic review exists to date. This study aims at assessing efficacy and tolerability of antidepressants compared to placebo in acute treatment at and beyond 8 weeks. DATA SOURCES: MEDLINE, Embase, PsycINFO, and CENTRAL databases were systematically searched through March 2014 using generic terms for depressive and affective disorders combined with generic terms for individual drugs and placebo...
January 3, 2017: Journal of Clinical Psychiatry
https://www.readbyqxmd.com/read/28066021/clomipramine-clomiphene-and-generic-drug-dispensing-errors
#10
Amar Bavle, Chittaranjan Andrade
No abstract text is available yet for this article.
July 2016: Indian Journal of Psychiatry
https://www.readbyqxmd.com/read/28065194/osteoporosis-drugs-marketed-in-the-united-states-generic-competition-pricing-structure-and-dispersion-among-payers
#11
Bander Balkhi, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio
BACKGROUND: Despite the cost of pharmaceuticals, studies assessing prices of osteoporosis drugs are lacking. This study examined trends in prices of osteoporosis drugs in the United States in the period 1988-2014, assessed pricing structure of osteoporosis drugs, and evaluated price trends before and after generic drugs market entry. METHODS: Data were derived from the U.S. Food and Drug Administration, the RedBook, the Centers for Medicare & Medicaid Services, and the Federal Supply Schedule (FSS)...
January 9, 2017: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/28052986/can-voluntary-pooled-procurement-reduce-the-price-of-antiretroviral-drugs-a-case-study-of-efavirenz
#12
Sung Wook Kim, Jolene Skordis-Worrall
PURPOSE: A number of strategies have aimed to assist countries in procuring antiretroviral therapy (ARV) at lower prices. In 2009, as the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) commenced a voluntary pooled procurement scheme, however, the impact of the scheme on ARV prices remains uncertain. This study aims to estimate the effect of VPP on drug prices using Efavirenz as a case study. METHODS: This analysis uses WHO Global price report mechanism (GPRM) data from 2004 to 2013...
January 4, 2017: Health Policy and Planning
https://www.readbyqxmd.com/read/28050392/paediatric-prescription-analysis-in-a-primary-health-care-institution
#13
Jinish Jose, Denny Devassykutty
INTRODUCTION: Paediatric prescription analysis was done by vari-ous studies in tertiary care centers but not much published data, at primary care level. The Medical Council of India introduced new prescription format and also antibiotic stewardship program was launched by Government of Kerala in the year 2015. So in these contexts this study was conducted. AIM: To analyse the patterns of prescriptions and drug dis-pensing in pediatric patients using WHO core drug use indicators and parameters in the prescription format prescribed by Medical Council of India...
November 2016: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28049571/biosimilar-and-generic-cancer-drugs-unlikely-to-bend-cost-curve-in-the-usa
#14
Charles L Bennett, Oliver A Sartor, James O Armitage, Hagop Kantarjian
No abstract text is available yet for this article.
January 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28045649/cost-effectiveness-of-pemetrexed-in-combination-with-cisplatin-as-first-line-treatment-for-patients-with-advanced-non-squamous-non-small-cell-lung-cancer-in-spain
#15
Jonathan González García, Fernando Gutiérrez Nicolás, Gloria Julia Nazco Casariego, Cristina Valcárcel Nazco, Jose Norberto Batista López, Juana Oramas Rodríguez
INTRODUCTION: Lung cancer is the third most frequent neoplastic tumour in Spain, with around 27 000 new cases diagnosed per year; 80-95% of these are non-small-cell cancer (NSCLC), and the majority of cases are diagnosed in advanced stages of the disease, and for this reason it is one of the oncologic conditions with higher mortality rates (21.4% mean survival at 5 years). The main treatment regimens used for first-line treatment of NSCLC are: cisplatin/pemetrexed (cis/pem), cisplatin/gemcitabine/ bevacizumab (cis/gem/bev), and carboplatin/paclitaxel/ bevacizumab (carb/pac/bev)...
January 1, 2017: Farmacia Hospitalaria
https://www.readbyqxmd.com/read/28042848/epidemiologic-features-of-enterovirus-71-associated-hand-foot-and-mouth-disease-from-2009-to-2013-in-zhejiang-china
#16
Zhifang Wang, Huakun Lv, Wenming Zhu, Zhe Mo, Guangming Mao, Xiaofeng Wang, Xiaoming Lou, Yongdi Chen
Enterovirus 71 (EV71) usually causes hand-foot-and-mouth disease (HFMD) with severe clinical symptoms and even deaths in China. There is no efficient antiviral drug to protect against severe EV71-associated HFMD, making the development of EV71 vaccines therefore a priority. However, the potential target subject population(s) to be immunized with EV71 vaccine are not well understood. In this study, we characterized the epidemiology regarding EV71-associated HFMD on the basis of provincial-level surveillance...
December 30, 2016: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28035437/does-substitution-of-brand-name-medications-by-generics-differ-between-pharmacotherapeutic-classes-a-population-based-cohort-study-in-france
#17
Alicia Molinier, Aurore Palmaro, Vanessa Rousseau, Agnès Sommet, Robert Bourrel, Jean-Louis Montastruc, Haleh Bagheri
PURPOSE: The purpose of this study was to measure the rate of substitution failure to generic antiepileptic drugs (AEDs) compared to two other pharmacotherapeutic classes (neuroleptics, beta-blockers). METHODS: We conducted a cohort study involving beneficiaries of the French health insurance system from January 2009 to November 2012. Substitution failure to generic drugs was estimated by the rate of switchback (i.e. from generic drug back to its branded drug). We selected the patients who had a dispensation of a branded AED for 60 days or more during the 90 days preceding the generic substitution...
December 29, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28035215/the-role-and-choice-criteria-of-antihistamines-in-allergy-management-expert-opinion
#18
Piotr Kuna, Dariusz Jurkiewicz, Magdalena M Czarnecka-Operacz, Rafał Pawliczak, Jarosław Woroń, Marcin Moniuszko, Andrzej Emeryk
Allergic diseases are the most common chronic conditions lasting throughout the patient's life. They not only cause significant deterioration in the quality of life of patients but also lead to significant absenteeism and reduced productivity, resulting in very high costs for society. Effective and safe treatment of allergic diseases is therefore one of the main challenges for public health and should be carried out by all the specialists in family medicine, internists and paediatricians in collaboration with allergists, otorhinolaryngologists and dermatologists...
December 2016: Postȩpy Dermatologii i Alergologii
https://www.readbyqxmd.com/read/28035201/the-role-of-biosimilars-in-inflammatory-bowel-disease
#19
Sudarshan Paramsothy, Noa Krugliak Cleveland, Nada Zmeter, David T Rubin
Monoclonal antibody biologic therapies, introduced nearly 20 years ago, revolutionized the treatment of inflammatory bowel disease (IBD) and are now well established as the most effective agents available. As the first of these biologic agents starts to come off patent, biosimilar agents have emerged as alternatives to originator drugs. The unique drug development and manufacturing processes involved in the creation of biologic agents pose distinct regulatory challenges compared to generic formulations of conventional medications...
December 2016: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28034518/sex-effect-on-average-bioequivalence
#20
Manuel Ibarra, Marta Vázquez, Pietro Fagiolino
PURPOSE: Generic formulations are by far the most prescribed drugs. This scenario is highly beneficial for society because medication expenses are significantly reduced after expiration of the exclusivity period conceded to the branded name drug. Correspondingly, these formulations must be adequately evaluated to avoid drug inefficacy and toxicity in the overall patient population. Bioequivalence studies are the only in vivo evaluation that a generic drug must overcome to reach the market...
December 26, 2016: Clinical Therapeutics
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