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https://www.readbyqxmd.com/read/28724167/in-vitro-controlled-release-of-two-new-tuberculocidal-adamantane-aminoethers-from-solid-pharmaceutical-formulations-ii
#1
Marilena Vlachou, Angeliki Siamidi, Dimitrios Spaneas, Dimitrios Lentzos, Polixeni Ladia, Konstantina Anastasiou, Ioannis Papanastasiou, Angeliki-Sofia Foscolos, Markos-Orestis Georgiadis, Vangelis Karalis, Tahsin Kellici, Thomas Mavromoustakos
The aim of the present investigation was to develop matrix tablet formulations for the in vitro controlled release of two new tuberculocidal adamantane aminoethers (compounds III and IV), congeneric to the adamantane derivative SQ109, which is in final clinical trials, and aminoethers (I) and (II), using carefully selected excipients, such as polyvinylpyrrolidone, sodium alginate and lactose. The tablets were prepared using the direct compression method and dissolution experiments were conducted using the US Pharmacopoeia type II apparatus (paddle method) in gastric and intestinal fluids...
July 19, 2017: Drug Research
https://www.readbyqxmd.com/read/28724033/ethical-issues-on-the-synthetic-phosphoethanolamine-clinical-trial
#2
Francisco José Roma Paumgartten
Notwithstanding its approval by the National Committee for Ethics in Research (Conep) on April 19, 2016, a trial of the so-called "synthetic" phosphoethanolamine (syn-phospho) pill in cancer patients raises ethical concerns. An analysis by a laboratory contracted by the Ministry of Science, Technology and Innovation (MCTI) revealed that syn-phospho contained a great amount of impurities and did not meet standards of pharmaceutical quality required for an investigational drug. Cytotoxicity against human tumor cell lines and in vivo rodent xenograft tumor assays consistently failed to demonstrate a potential anticancer activity of syn-phospho...
May 2017: Revista da Associação Médica Brasileira
https://www.readbyqxmd.com/read/28722322/advanced-methods-for-dose-and-regimen-finding-during-drug-development-summary-of-the-ema-efpia-workshop-on-dose-finding-london-4-5-december-2014
#3
F T Musuamba, E Manolis, N Holford, Sya Cheung, L E Friberg, K Ogungbenro, M Posch, Jwt Yates, S Berry, N Thomas, S Corriol-Rohou, B Bornkamp, F Bretz, A C Hooker, P H Van der Graaf, J F Standing, J Hay, S Cole, V Gigante, K Karlsson, T Dumortier, N Benda, F Serone, S Das, A Brochot, F Ehmann, R Hemmings, I Skottheim Rusten
Inadequate dose selection for confirmatory trials is currently still one of the most challenging issues in drug development, as illustrated by high rates of late-stage attritions in clinical development and postmarketing commitments required by regulatory institutions. In an effort to shift the current paradigm in dose and regimen selection and highlight the availability and usefulness of well-established and regulatory-acceptable methods, the European Medicines Agency (EMA) in collaboration with the European Federation of Pharmaceutical Industries Association (EFPIA) hosted a multistakeholder workshop on dose finding (London 4-5 December 2014)...
July 19, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28721009/patient-profiles-and-clinical-utility-of-mepolizumab-in-severe-eosinophilic-asthma
#4
REVIEW
Pranabashis Haldar
Mepolizumab (Nucala(®)) is an effective and specific anti-eosinophil molecular therapy that has recently been approved as add-on therapy for the management of severe eosinophilic asthma by the US Food and Drug Administration (FDA), European Medicines Agency (EMA; European Union) and more recently National Institute for Health and Care Excellence (NICE; UK). It is one of several molecular therapies in development for this indication and is illustrative of the strategic trajectory for pharmaceutical drug development taken over the past decade in several disease areas...
2017: Biologics: Targets & Therapy
https://www.readbyqxmd.com/read/28720208/treatment-of-uremic-pruritus-a-systematic-review
#5
Elizabeth Simonsen, Paul Komenda, Blake Lerner, Nicole Askin, Clara Bohm, James Shaw, Navdeep Tangri, Claudio Rigatto
BACKGROUND: Uremic pruritus is a common and burdensome symptom afflicting patients with advanced chronic kidney disease (CKD) and has been declared a priority for CKD research by patients. The optimal treatments for uremic pruritus are not well defined. STUDY DESIGN: Systematic review. SETTING & POPULATION: Adult patients with advanced CKD (stage ≥ 3) or receiving any form of dialysis. SELECTION CRITERIA FOR STUDIES: PubMed, CINAHL, Embase, International Pharmaceutical Abstracts, Scopus, Cochrane Library, and ClinicalTrials...
July 15, 2017: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
https://www.readbyqxmd.com/read/28720121/the-effectiveness-of-daily-sms-reminders-in-pharmaceutical-care-of-older-adults-on-improving-patients-adherence-to-antihypertensive-medication-sppa-study-protocol-for-a-randomized-controlled-trial
#6
Zuzana Haramiova, Michal Stasko, Martin Hulin, Tomas Tesar, Magdalena Kuzelova, Donald M Morisky
BACKGROUND: Despite a variety of efficient and cost-effective antihypertensive medication, hypertension remains a serious health and economic burden. High consumption of cardiovascular drugs in the Slovak Republic does result neither in better hypertension control nor in significant decrease in cardiovascular mortality. At the same time, Slovakia has alarmingly low patients' adherence to medication intake. Studies have shown the efficiency of short messaging service (SMS) reminders to improve patients' adherence and health outcomes at low costs...
July 18, 2017: Trials
https://www.readbyqxmd.com/read/28718326/cns-anticancer-drug-discovery-and-development-2016-conference-insights
#7
Victor A Levin, Lauren E Abrey, Timothy P Heffron, Peter J Tonge, Arvin C Dar, William A Weiss, James M Gallo
CNS Anticancer Drug Discovery and Development November 2016, AZ, USA The 2016 second CNS Anticancer Drug Discovery and Development Conference addressed diverse viewpoints about why new drug discovery/development focused on CNS cancers has been sorely lacking. Despite more than 70,000 individuals in the USA being diagnosed with a primary brain malignancy and 151,669-286,486 suffering from metastatic CNS cancer, in 1999, temozolomide was the last drug approved by the US FDA as an anticancer agent for high-grade gliomas...
July 18, 2017: CNS Oncology
https://www.readbyqxmd.com/read/28716314/safety-and-efficacy-of-ebselen-for-the-prevention-of-noise-induced-hearing-loss-a-randomised-double-blind-placebo-controlled-phase-2-trial
#8
Jonathan Kil, Edward Lobarinas, Christopher Spankovich, Scott K Griffiths, Patrick J Antonelli, Eric D Lynch, Colleen G Le Prell
BACKGROUND: Noise-induced hearing loss is a leading cause of occupational and recreational injury and disease, and a major determinant of age-related hearing loss. No therapeutic agent has been approved for the prevention or treatment of this disorder. In animal models, glutathione peroxidase 1 (GPx1) activity is reduced after acute noise exposure. Ebselen, a novel GPx1 mimic, has been shown to reduce both temporary and permanent noise-induced hearing loss in preclinical studies. We assessed the safety and efficacy of ebselen for the prevention of noise-induced hearing loss in young adults in a phase 2 clinical trial...
July 14, 2017: Lancet
https://www.readbyqxmd.com/read/28715990/single-subject-studies-in-translational-nutrition-research
#9
Nicholas J Schork, Laura H Goetz
There is a great deal of interest in personalized, individualized, or precision interventions for disease and health-risk mitigation. This is as true of nutrition-based intervention and prevention strategies as it is for pharmacotherapies and pharmaceutical-oriented prevention strategies. Essentially, technological breakthroughs have enabled researchers to probe an individual's unique genetic, biochemical, physiological, behavioral, and exposure profile, allowing them to identify very specific and often nuanced factors that an individual might possess, which may make it more or less likely that he or she responds favorably to a particular intervention (e...
July 17, 2017: Annual Review of Nutrition
https://www.readbyqxmd.com/read/28713147/to-enroll-or-not-to-enroll-a-researcher-struggles-with-the-decision-to-involve-study-participants-in-a-clinical-trial-that-could-save-their-lives
#10
Roberto Abadie
Hundreds of thousands of clinical trials are conducted annually around the world, working to further scientific knowledge and expand medical treatment. At the same time, clinical trials also present novel challenges to researchers who have access to large pools of research participants and are routinely approached by pharmaceutical companies seeking to recruit subjects for clinical trials. This case study discusses the ethical dilemmas faced by a community health investigator who received an invitation to enroll people who inject drugs (PWID) into a clinical trial of a drug that promised a new treatment option for Hepatitis C...
2017: Narrative Inquiry in Bioethics
https://www.readbyqxmd.com/read/28710219/comparison-of-propofol-and-dexmedetomidine-infused-overnight-to-treat-hyperactive-and-mixed-icu-delirium-a-protocol-for-the-basel-prodex-clinical-trial
#11
Alexa Hollinger, Katrin Ledergerber, Stefanie von Felten, Raoul Sutter, Stephan Rüegg, Lukas Gantner, Sibylle Zimmermann, Andrea Blum, Luzius A Steiner, Stephan Marsch, Martin Siegemund
BACKGROUND/OBJECTIVES: Delirium is a neurobehavioural disturbance that frequently develops particularly in the intensive care unit (ICU) population. It was first described more than half a century ago, where it was already discovered as a state that might come along with serious complications such as prolonged ICU and hospital stay, reduced quality of life and increased mortality. However, in most cases, there is still lack of proof for causal relationship. Its presence frequently remains unrecognised due to suggested predominance of the hypoactive form...
July 13, 2017: BMJ Open
https://www.readbyqxmd.com/read/28708957/influenza-vaccination-in-the-elderly
#12
Smetana Jan, Chlibek Roman, Shaw Jana, Splino Miroslav, Prymula Roman
Seasonal influenza is a prevalent and serious annual illness resulting in widespread morbidity and economic disruption throughout the population; the elderly and immunocompromised are particularly vulnerable to serious sequelae and mortality. The changing demographics worldwide to an aging society have important implications for public health policy and pharmaceutical innovations. For instance, primary prevention via immunization is effective in reducing the burden of influenza illness among the elderly. However, the elderly may be insufficiently protected by vaccination due to the immunosenescence which accompanies aging...
July 14, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28707751/oral-antifungal-medication-for-toenail-onychomycosis
#13
REVIEW
Sanne Kreijkamp-Kaspers, Kate Hawke, Linda Guo, George Kerin, Sally Em Bell-Syer, Parker Magin, Sophie V Bell-Syer, Mieke L van Driel
BACKGROUND: Fungal infection of the toenails, also called onychomycosis, is a common problem that causes damage to the nail's structure and physical appearance. For those severely affected, it can interfere with normal daily activities. Treatment is taken orally or applied topically; however, traditionally topical treatments have low success rates due to the nail's physical properties. Oral treatments also appear to have shorter treatment times and better cure rates. Our review will assist those needing to make an evidence-based choice for treatment...
July 14, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28707076/correlation-of-changes-in-patient-reported-quality-of-life-with-physician-rated-global-impression-of-change-in-patients-with-narcolepsy-participating-in-a-clinical-trial-of-sodium-oxybate-a-post-hoc-analysis
#14
Richard K Bogan, Jed Black, Todd Swick, Mortimer Mamelak, Ruzica Kovacevic-Ristanovic, Kathleen F Villa, Fannie Mori, Jacques Montplaisir
INTRODUCTION: Narcolepsy patients report lower health-related quality of life (HRQoL) than the general population, as measured by the Short Form-36 Health Survey (SF-36). This analysis evaluated whether changes in SF-36 correlated with physician-rated Clinical Global Impression of Change (CGI-C). METHODS: Data were from 209 of 228 narcolepsy patients participating in an 8-week clinical trial of sodium oxybate. Changes from baseline for SF-36 subscales (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health) and the summary scores were evaluated for correlation with CGI-C overall and by treatment group...
July 13, 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/28705037/saffron-and-its-derivatives-crocin-crocetin-and-safranal-a-patent-review
#15
Maryam Rameshrad, Bibi Marjan Razavi, Hossein Hosseinzadeh
Saffron and its main components have traditionally been used as pharmaceutical agents. Current experimental research projects have also exhibited their applications in a wide spectrum of disorder treatments. Area covered: This review covers the demonstrated findings and patents on therapeutic/pharmaceutical properties of saffron and related derivatives, since 2000 to bold their outstanding merit on human health. An extensive literature review was performed in USP Patent, Patentscope, Espacenet and Google Patent in the field of CNS, cardiovascular, urogenital, dermatological and inflammatory disorders...
July 13, 2017: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/28703260/-publish-amp-perish-research-on-research-and-researchers
#16
J K Tijdink
In the last years many people have questioned the reliability of research results and the societal relevance of much of today's clinical research; they are critical too about the current publication culture in which scientists are judged according to the number of articles they have published, impact factors and citations.<br/> AIM: To make a close study of the publication culture that now prevails in the Dutch biomedical sciences. <br/> METHOD: Discussion of results described in the thesis entitled 'Publish and Perish; research on research and researchers'...
2017: Tijdschrift Voor Psychiatrie
https://www.readbyqxmd.com/read/28699788/allogeneic-cell-therapy-manufacturing-process-development-technologies-and-facility-design-options
#17
Saeed Abbasalizadeh, Mohammad Pakzad, Joaquim M S Cabral, Hossein Baharvand
Currently, promising outcomes from clinical trials of allogeneic cells, especially allogeneic mesenchymal stromal cells, fibroblasts, keratinocytes, and human cardiac stem cells, have encouraged research institutions, small and medium enterprises (SMEs), and big pharmaceutical companies to invest and focus on developing allogeneic cell therapy products. Commercial and large-scale production of allogeneic cell therapy products requires unique capabilities to develop technologies that generate safe and effective allogeneic cells/cell lines and their fully characterized master/working banks...
July 12, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28699508/edible-vaccine-current-status-and-future-perspectives
#18
Sayed Sartaj Sohrab, Mohd Suhail, Mohammad A Kamal, Azamal Husen, Esam I Azhar
Growing world population and continuous disease emergence have invited the development of more efficient new vaccines against a range of diseases. Conventional vaccines are being wildly used in the world but their production requires higher cost, more time and better infrastructure. Thus, the idea of plant-based edible vaccine technology has emerged and showed promising results with strong and effective protection against many diseases. Plants have been utilized since more than two decades as pharmaceuticals against many diseases...
July 11, 2017: Current Drug Metabolism
https://www.readbyqxmd.com/read/28699488/a-review-of-interventions-to-improve-enrolment-and-attendance-to-cardiac-rehabilitation-among-patients-aged-65-years-or-above
#19
Bashir M Matata, Sean Andrew Williamson
Purpose This review provides an overview and quality assessment of existing interventions, assessing the intervention types that are most effective at increasing enrolment and adherence to cardiac rehabilitation in older patients aged ≥65 years Methods The review of the literature was performed using electronic databases that searched for randomised controlled trials that aimed to increase enrolment and/or adherence to cardiac rehabilitation in older patients aged ≥65 years. The main key words were cardiac rehabilitation, enrolment, adherence and older patients...
July 9, 2017: Current Cardiology Reviews
https://www.readbyqxmd.com/read/28699051/-assessing-the-added-benefit-of-new-ophthalmic-drugs-which-additional-insights-can-be-extracted-from-the-early-benefit-assessment
#20
REVIEW
M Appelrath, G Glaeske
Until now six ophthalmic agents have undergone the German early benefit assessment according to § 35a Social Security Code (SGB) V in a total of eleven indications. Only one agent (ocriplasmin) was recognized by the Federal Joint Committee as having an added benefit based on submitted study data for a subpopulation (indication of a considerable added benefit, limited for 5 years) and another agent, idebenone, received an added benefit due to its orphan drug designation (proof of a not quantifiable added benefit, limited for 2 years)...
July 11, 2017: Der Ophthalmologe: Zeitschrift der Deutschen Ophthalmologischen Gesellschaft
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