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https://www.readbyqxmd.com/read/29048798/-comparison-of-cim-%C3%A2-c4-hld-monolithic-column-with-sartobind-phenyl-membrane-column-for-pidke2-purification
#1
Limonta Miladys, ZumalacÁRregui Lourdes, Vidic Urska, Lendero Krajnc Nika
The main component of the Center for Genetic Engineering and Biotechnology (CIGB) candidate vaccine against Hepatitis C virus (HCV) is the pIDKE2 plasmid.The current designed downstream process for the production of pIDKE2 fulfils all regulatory requirements and renders the required quantities of pharmaceutical-grade plasmid DNA (pDNA) with 95% purity.The advantages of this procedure include high plasmid purity and the elimination of undesirable additives,such as toxic organic extractants and animal-derived enzymes...
October 8, 2017: Se Pu, Chinese Journal of Chromatography
https://www.readbyqxmd.com/read/29048257/desmopressin-acetate-nasal-spray-for-adults-with-nocturia
#2
Joshua A Cohn, Casey G Kowalik, W Stuart Reynolds, Melissa R Kaufman, Douglas F Milam, Roger R Dmochowski, Alan J Wein
Nocturia impacts 70% of individuals over age 70 years. Nocturnal polyuria is present in up to 88% of adults with nocturia, however, treatment options for reducing nighttime urine production have historically been limited to behavioral modification and off label use of timed diuretics and desmopressin. Noctiva(TM) (desmopressin acetate nasal spray, DANS, Serenity Pharmaceuticals, LLC) is a novel formulation of desmopressin approved by the Food and Drug Administration for the treatment of nocturia due to nocturnal polyuria in March 2017...
October 19, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/29047408/the-efficacy-of-the-kampo-medicine-rikkunshito-for-chemotherapy-induced-anorexia-rich-trial-study-protocol-for-a-randomized-controlled-trial
#3
Takuya Inoue, Hironori Takagi, Yuki Owada, Yuzuru Watanabe, Takumi Yamaura, Mitsuro Fukuhara, Satoshi Muto, Naoyuki Okabe, Yuki Matsumura, Takeo Hasegawa, Jun Osugi, Mika Hoshino, Mitsunori Higuchi, Yutaka Shio, Hiroshi Yokouchi, Kenya Kanazawa, Katsuya Ohbuchi, Takahisa Fukushima, Mitsuru Munakata, Hiroyuki Suzuki
BACKGROUND: Cisplatin is a key drug in lung cancer therapy. However, cisplatin is also well known to induce gastrointestinal disorders, such as chemotherapy-induced nausea and vomiting, anorexia, and weight loss. These symptoms sometimes affect patients' quality of life and make continuation of chemotherapy difficult. Anorexia is a cause of concern for patients with cancer because a persistent loss of appetite progresses to cancer cachexia. Although evidence-based management for chemotherapy has recently been established, there is room for improvement...
October 18, 2017: Trials
https://www.readbyqxmd.com/read/29045553/randomized-controlled-trial-of-s-1-versus-docetaxel-in-patients-with-non-small-cell-lung-cancer-previously-treated-with-platinum-based-chemotherapy-east-asia-s-1-trial-in-lung-cancer
#4
H Nokihara, S Lu, T S K Mok, K Nakagawa, N Yamamoto, Y K Shi, L Zhang, R A Soo, J C Yang, S Sugawara, M Nishio, T Takahashi, K Goto, J Chang, M Maemondo, Y Ichinose, Y Cheng, W T Lim, S Morita, T Tamura
Background: Chemotherapy remains a viable option for the management of advanced non-small-cell lung cancer (NSCLC) despite recent advances in molecular targeted therapy and immunotherapy. We evaluated the efficacy of oral 5-fluorouracil-based S-1 as second- or third-line therapy compared with standard docetaxel therapy in patients with advanced NSCLC. Patients and methods: Patients with advanced NSCLC previously treated with ≥1 platinum-based therapy were randomized 1:1 to docetaxel (60 mg/m2 in Japan, 75mg/m2 at all other study sites; day 1 in a 3-week cycle) or S-1 (80-120 mg/day, depending on body surface area; days 1-28 in a 6-week cycle)...
September 29, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29041909/cost-utility-analysis-of-palivizumab-for-respiratory-syncytial-virus-infection-prophylaxis-in-preterm-infants-update-based-on-the-clinical-evidence-in-spain
#5
M Sanchez-Luna, R Burgos-Pol, I Oyagüez, J Figueras-Aloy, M Sánchez-Solís, F Martinón-Torres, X Carbonell-Estrany
BACKGROUND: This study aimed at estimating the efficiency of palivizumab in the prevention of Respiratory Syncytial Virus (RSV) infection and its sequelae in preterm infants (32(day 1)-35(day 0)weeks of gestational age -wGA-) in Spain. METHODS: A decision-tree model was developed to compare health benefits (Quality Adjusted Life Years-QALYs) and costs of palivizumab versus a non-prophylaxis strategy over 6 years. A hypothetical cohort of 1,000 preterm infants, 32(day 1)-35(day 0) wGA (4...
October 17, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/29040157/development-and-use-of-biochemical-markers-in-osteoarthritis-current-update
#6
Anne C Bay-Jensen, Christian S Thudium, Ali Mobasheri
PURPOSE OF REVIEW: There is an increasing demand for noninvasive and descriptive biochemical markers (biomarkers) in osteoarthritis; for enabling early drug development (including translational research), evaluating clinical trial at an early stage and for subtyping. Purpose of the review is to review and comment on current availability of such biomarkers. RECENT FINDINGS: Many different biomarkers have been tested in the last 18 months. The main focus has been on testing whether the biomarkers, whether is reflect joint tissue turnover or inflammatory status, can differentiate osteoarthritis patients from healthy controls or whether the biomarkers are associated with progression...
October 16, 2017: Current Opinion in Rheumatology
https://www.readbyqxmd.com/read/29038906/pcsk9-mutations-in-familial-hypercholesterolemia-from-a-groundbreaking-discovery-to-anti-pcsk9-therapies
#7
REVIEW
Petra El Khoury, Sandy Elbitar, Youmna Ghaleb, Yara Abou Khalil, Mathilde Varret, Catherine Boileau, Marianne Abifadel
PURPOSE OF REVIEW: In 2003, Abifadel et al. (Nat. Genet. 34:154-156, 2003) identified PCSK9, encoding proprotein convertase subtilisin/kexin type 9, as the third causal gene for autosomal dominant hypercholesterolemia. This review focuses on the main steps from this major breakthrough in familial hypercholesterolemia (FH) to the latest clinical trials with the anti-PCSK9 antibodies. RECENT FINDINGS: The year 2015 was remarkable in cardiovascular disease through the field of cholesterol...
October 17, 2017: Current Atherosclerosis Reports
https://www.readbyqxmd.com/read/29038700/the-clinical-evaluation-of-vi-one-chlorhexidine-mouthwash-on-plaque-induced-gingivitis-a-double-blind-randomized-clinical-trial
#8
Babak Amoian, Marzyeh Omidbakhsh, Soraya Khafri
BACKGROUND: Chlorhexidine (CHX) is the most effective antiseptic mouthwash to date. Essential oil such as thymol, have inhibitory and biocidal effects a range of bacteria. OBJECTIVE: To determine the effect of mouthwash containing CHX and thymol on plaque induced gingivitis. METHODS: This double-blind randomized clinical trial study was performed on 60 patients with plaque induced gingivitis who were randomly divided into two groups: Group I (CHX/thymol mouthwash-Vi-one) and Group II (CHX mouthwash-Behsa)...
September 2017: Electronic Physician
https://www.readbyqxmd.com/read/29038075/biochemical-marker-discovery-testing-and-evaluation-for-facilitating-oa-drug-discovery-and-development
#9
REVIEW
Anne-Christine Bay-Jensen, Christian S Thudium, Oreste Gualillo, Ali Mobasheri
Osteoarthritis (OA) is the most common form of joint disease. This presents the OA research community and pharmaceutical companies developing disease-modifying OA drugs (DMOADs) with great opportunities. The different OA subtypes complicate the traditional approaches for developing new treatments. If we can identify new markers that can distinguish different subtypes this could greatly facilitate drug development from early discovery to late clinical development. Nevertheless, the current approaches result in poorly targeted treatments and the inability to recruit the right patients for clinical trials...
October 13, 2017: Drug Discovery Today
https://www.readbyqxmd.com/read/29037091/an-anthropometric-survey-of-u-s-preterm-and-full-term-neonates
#10
Susan M Abdel-Rahman, Ian M Paul, Paula Delmore, Laura James, Laura Fearn, Andrew M Atz, Brenda B Poindexter, Amira Al-Uzri, Andrew Lewandowski, Barrie L Harper, P Brian Smith
BACKGROUND: Anthropometric data prove valuable for screening and monitoring various medical conditions. In young infants, however, only weight, length and head circumference are represented in publically accessible databases. AIM: To characterise length and circumferential measures in preterm and full-term infants up to 90 days postnatal age. SUBJECTS AND METHODS: In eight U.S. medical centres, trained raters recorded humeral, ulnar, femoral, tibial, and fibular lengths along with mid-upper arm, mid-thigh, chest, abdominal, and neck circumference...
October 16, 2017: Annals of Human Biology
https://www.readbyqxmd.com/read/29036837/simvastatin-as-a-potential-disease-modifying-therapy-for-patients-with-parkinson-s-disease-rationale-for%C3%A2-clinical-trial-and-current-progress
#11
Camille B Carroll, Richard K H Wyse
Many now believe the holy grail for the next stage of therapeutic advance surrounds the development of disease-modifying approaches aimed at intercepting the year-on-year neurodegenerative decline experienced by most patients with Parkinson's disease (PD). Based on recommendations of an international committee of experts who are currently bringing multiple, potentially disease-modifying, PD therapeutics into long-term neuroprotective PD trials, a clinical trial involving 198 patients is underway to determine whether Simvastatin provides protection against chronic neurodegeneration...
October 13, 2017: Journal of Parkinson's Disease
https://www.readbyqxmd.com/read/29035430/the-use-pattern-and-clinical-impact-of-new-antiplatelet-agents-including-prasugrel-and-ticagrelor-on-30-day-outcomes-after-acute-myocardial-infarction-in-korea-korean-health-insurance-review-and-assessment-data
#12
Choongki Kim, Dong Ho Shin, Chul Min Ahn, Jung Sun Kim, Byeong Keuk Kim, Young Guk Ko, Donghoon Choi, Myeong Ki Hong, Juhee Park, Hyeyeong Lee, Yoon Jung Choi, Youn Song Choi, Sang Kwon Oh, Yangsoo Jang
BACKGROUND AND OBJECTIVES: Despite the favorable efficacy of new antiplatelet agents demonstrated in randomized controlled trials, their clinical implications in Korea are unclear. The purpose of this study was to investigate trends in antiplatelet agent use for acute myocardial infarction (AMI) and their impact on 30-day clinical outcomes. METHODS: AMI patients undergoing percutaneous coronary intervention between 2010 and 2015 were assessed using claim data from the Health Insurance Review and Assessment Service...
September 12, 2017: Korean Circulation Journal
https://www.readbyqxmd.com/read/29034722/the-efficacy-of-apaziquone-in-the-treatment-of-bladder-cancer
#13
Francesco Caramés Masana, Theo M de Reijke
Bladder cancer is nowadays a common tumor. Non-muscle invasive bladder cancer (NMIBC) has still chances of recurrence and progression in spite of surgery and adjuvant treatments. New therapies are being developed to reduce these percentages with less adverse effects - Apaziquone (EO9) is an example. Areas covered: A literature search has been performed using Pubmed, UpToDate and Google verified information (mainly from Food and Drug Administration and Spectrum Pharmaceutics websites). We have included data from the most representative clinical trials and reviews published...
October 16, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29033099/custirsen-ogx-011-combined-with-cabazitaxel-and-prednisone-versus-cabazitaxel-and-prednisone-alone-in-patients-with-metastatic-castration-resistant-prostate-cancer-previously-treated-with-docetaxel-affinity-a-randomised-open-label-international-phase-3-trial
#14
Tomasz M Beer, Sebastien J Hotte, Fred Saad, Boris Alekseev, Vsevolod Matveev, Aude Fléchon, Gwenaelle Gravis, Florence Joly, Kim N Chi, Zafar Malik, Brent Blumenstein, Patricia S Stewart, Cindy A Jacobs, Karim Fizazi
BACKGROUND: Docetaxel and cabazitaxel improve overall survival compared with mitoxantrone in patients with metastatic castration-resistant prostate cancer. Custirsen (OGX011) is a second generation highly specific antisense oligonucleotide that inhibits the production of clusterin, an antiapoptotic protein that is upregulated in response to chemotherapy and that confers treatment resistance. We aimed to assess whether custirsen in combination with cabazitaxel and prednisone increases overall survival in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel...
October 9, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29032849/mapping-the-landscape-of-patient-centric-activities-within-clinical-research
#15
Mary Jo Lamberti, Josephine Awatin
PURPOSE: Although there has been more involvement by patients in the drug-development process, there are not a lot of published data that quantify patient-centric activities or that document these activities across a large scale. In order to examine the patient-centricity landscape and to quantify the adoption and implementation of these initiatives, the Tufts Center for the Study of Drug Development and the Drug Information Association collaborated on a research study. The study examined patient-centric activities implemented by pharmaceutical, biotechnology, and contract research organizations, as well as activities being piloted or in the planning stages...
October 9, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29030423/graphics-and-statistics-for-cardiology-designing-effective-tables-for-presentation-and-publication
#16
REVIEW
Maarten Boers
Research is of little use if its results are not effectively communicated. Data visualised in tables (and graphs) are key components in any scientific report, but their design leaves much to be desired. This article focuses on table design, following two general principles: clear vision and clear understanding. Clear vision is achieved by maximising the signal to noise ratio. In a table, the signal is the data in the form of numbers, and the noise is the support structure necessary to interpret the numbers...
October 13, 2017: Heart: Official Journal of the British Cardiac Society
https://www.readbyqxmd.com/read/29030411/global-shortage-of-neonatal-and-paediatric-antibiotic-trials-rapid-review
#17
Georgina Thompson, Charlotte I Barker, Laura Folgori, Julia A Bielicki, John S Bradley, Irja Lutsar, Mike Sharland
OBJECTIVES: There have been few clinical trials (CTs) on antibiotics that inform neonatal and paediatric drug labelling. The rate of unlicensed and off-label prescribing in paediatrics remains high. It is unclear whether the current neonatal and paediatric antibiotic research pipeline is adequate to inform optimal drug dosing. Using the ClinicalTrials.gov registry, this review aims to establish the current global status of antibiotic CTs in children up to 18 years of age. METHODS: Studies were identified using key word searches of the ClinicalTrials...
October 13, 2017: BMJ Open
https://www.readbyqxmd.com/read/29029810/characteristics-and-changes-of-pediatric-therapeutic-trials-under-the-best-pharmaceuticals-for-children-act
#18
Debbie Avant, Gerold T Wharton, Dianne Murphy
No abstract text is available yet for this article.
October 10, 2017: Journal of Pediatrics
https://www.readbyqxmd.com/read/29028878/web-based-drug-repurposing-tools-a-survey
#19
Elizabeth Sam, Prashanth Athri
Drug repurposing (a.k.a. drug repositioning) is the search for new indications or molecular targets distinct from a drug's putative activity, pharmacological effect or binding specificities. With the ever-increasing rates of termination of drugs in clinical trials, drug repositioning has risen as one of the effective solutions against the risk of drug failures. Repositioning finds a way to reverse the grim but real trend that Eroom's law portends for the pharmaceutical and biotech industry, and drug discovery in general...
October 6, 2017: Briefings in Bioinformatics
https://www.readbyqxmd.com/read/29028616/simultaneous-determination-of-a-novel-c-met-axl-dual-target-small-molecule-inhibitor-bpi-9016m-and-its-metabolites-in-human-plasma-by-liquid-chromatography-tandem-mass-spectrometry-application-in-a-pharmacokinetic-study-in-chinese-advanced-solid-tumor-patients
#20
Xinge Cui, Xin Zheng, Ji Jiang, Fenlai Tan, Lieming Ding, Pei Hu
BPI-9016M is a novel dual-target small-molecule inhibitor targeting c-Met and AXL, which was developed by Betta Pharmaceuticals Co., Ltd (Hangzhou, China). It has great potential in the treatment of advanced cancer. A high throughput quantitation method, based on liquid chromatography-tandem mass spectrometry, was developed and validated for the simultaneous determination of BPI-9016M and its main metabolite, M1 and M2-2, in human plasma with a sample preparation method of precipitation of protein. Liquid chromatographic separation was performed with a gradient elution of formic acid-10mM ammonium acetate aqueous solution (1:1000, v/v) and acetonitrile at a flow rate of 0...
October 8, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
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