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Drugs in R&D

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https://www.readbyqxmd.com/read/28389998/psychotropic-drug-related-fall-incidents-in-nursing-home-residents-living-in-the-eastern-part-of-the-netherlands
#1
Sarah I M Janus, Gezinus H Reinders, Jeannette G van Manen, Sytse U Zuidema, Maarten J IJzerman
BACKGROUND: Older people are more susceptible to falls than younger people. Therefore, as the Dutch population ages, the total number of falls and costs associated with them will rise. The use of psychotropic drugs is associated with an increased risk of falling. To create tailored fall-prevention programmes, information on the magnitude of the association between fall incidents and specific psychotropic drugs or drug classes is needed. OBJECTIVE: The goal of this study was to delineate the associations between fall incidents and specific psychotropic drugs or drug classes...
April 8, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28386738/manufacturing-of-recombinant-human-follicle-stimulating-hormone-ovaleap-%C3%A2-xm17-comparability-with-gonal-f-%C3%A2-and-performance-consistency
#2
Rainer Winstel, Juergen Wieland, Beate Gertz, Arnd Mueller, Hermann Allgaier
Ovaleap(®) (XM17) is a recombinant human follicle-stimulating hormone to treat infertility by inducing ovulation or controlled ovarian stimulation for assisted reproductive technology (ART) procedures. Ovaleap(®) (follitropin-α) was approved by the European Medicines Agency in 2013 as a biosimilar medicinal product to the reference medicine, Gonal-f(®). Information is often not easily accessible and/or publicly available regarding the rigorous manufacturing procedures for biosimilars. Objectives of the current analysis were to report on validation procedures for the Ovaleap(®) manufacturing process, to compare the characteristics of Ovaleap(®) versus Gonal-f(®), and to describe the performance and consistency of Ovaleap(®)...
April 6, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28324583/revisiting-cdk-inhibitors-for-treatment-of-glioblastoma-multiforme
#3
REVIEW
Dorota Lubanska, Lisa Porter
Despite extensive efforts and continual progress in research and medicine, outcomes for patients with high-grade glioma remain exceptionally poor. Over the past decade, research has revealed a great deal about the complex biology behind glioma development, and has brought to light some of the major barriers preventing successful treatment. Glioblastoma multiforme (GBM) (stage 4 astrocytoma) is a highly dynamic tumour and one of the most extreme examples of intratumoural heterogeneity, making targeting with specific therapeutics an inefficient and highly unpredictable goal...
March 21, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28299646/hyperlipidemia-alters-the-pharmacokinetics-of-posaconazole-and-vincristine-upon-co-administration-in-rats
#4
Hadeel A Khalil, Mohammed A W ElKhatib, Tarek S Belal, Ahmed F El-Yazbi, Dalia A Hamdy
OBJECTIVES: Co-administration of posaconazole (PSZ) and vincristine (VCR) in the treatment of patients with acute lymphoblastic leukemia increases the neurotoxicity of VCR. Our aim is to study the effect of increased lipoprotein levels on the pharmacokinetics of PSZ and VCR upon co-administration in rats. METHODS: Rats were assigned to three groups, normolipidemic (NL), intermediate hyperlipidemic (IHL), and extreme hyperlipidemic (HL) groups. All rats were administered PSZ orally followed by VCR intravenously 4 h later...
March 15, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28285448/canagliflozin-as-an-initial-therapy-in-drug-na%C3%A3-ve-subjects-with-type-2-diabetes-mellitus-a-potential-involvement-of-atherogenic-lipids-in-its-glycemic-efficacy
#5
Eiji Kutoh, Asuka Wada, Teruma Murayama, Yui Takizawa
BACKGROUND AND OBJECTIVES: The aim of this study is to investigate canagliflozin as an initial therapy in type 2 diabetes mellitus and to explore the effects on metabolic parameters in relation to effects on glycemic control. SUBJECTS AND METHODS: Treatment-naïve subjects with type 2 diabetes mellitus received canagliflozin 50-100 mg/day monotherapy. At 3 months, levels of glycemic and non-glycemic parameters were compared with those at baseline (n = 39). As a comparator, our previous data of baseline glycosylated hemoglobin (HbA1c)-matched treatment-naïve subjects with ipragliflozin 25-50 mg monotherapy (n = 27) were employed...
March 11, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28258478/in-vitro-diagnosis-of-immediate-drug-hypersensitivity-anno-2017-potentials-and-limitations
#6
REVIEW
I I Decuyper, E A Mangodt, A L Van Gasse, K Claesen, A Uyttebroek, M Faber, V Sabato, C H Bridts, C Mertens, M M Hagendorens, L S De Clerck, Didier G Ebo
BACKGROUND: For most physicians, quantification of drug-specific immunoglobulin E (drug-sIgE) antibodies constitutes the primary in vitro measure to document immediate drug hypersensitivity reactions (IDHR). Unfortunately, this is often insufficient to correctly identify patients with IgE-mediated IDHR and impossible for non-IgE-mediated IDHR that result from alternative routes of basophil and mast cell activation. In these difficult cases, diagnosis might benefit from cellular tests such as basophil activation tests (BAT)...
March 4, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28229376/the-pharmacogenetics-of-tacrolimus-in-corticosteroid-sparse-pediatric-and-adult-kidney-transplant-recipients
#7
Mads Juul Madsen, Troels K Bergmann, Kim Brøsen, Helle Charlotte Thiesson
INTRODUCTION: Tacrolimus is a calcineurin inhibitor used as an immunosuppressant drug in solid organ transplantation, and is mainly metabolized by cytochrome P450 (CYP) 3A4 and CYP3A5. Studies have shown an association between the CYP3A5 genotype and tacrolimus dose-adjusted trough concentrations. Variants in the genes PPARA, POR and CYP3A4 have recently been shown to influence tacrolimus metabolism. Furthermore, pharmacokinetic interaction between corticosteroid treatment and tacrolimus has been shown...
February 22, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28160230/risk-evaluation-and-mitigation-strategies-remss-are-they-improving-drug-safety-a-critical-review-of-remss-requiring-elements-to-assure-safe-use-etasu
#8
REVIEW
Pol F Boudes
Risk Evaluation and Mitigation Strategies (REMSs) with Elements to Assure Safe Use (ETASU) are requested for drugs with significant safety risks. We reviewed REMS programs issued since 2011 to evaluate their rationales, characteristics, and consistencies, and evaluated their impact on improving drug safety. We conducted a literature search and a survey of relevant websites (FDA, manufacturers, and REMSs). ETASU characteristics were summarized. REMS risks were compared with labeled risks, including black box warnings...
February 3, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28124232/effectiveness-and-risk-factors-for-virological-outcome-of-raltegravir-based-therapy-for-treatment-experienced-hiv-infected-patients
#9
José Antonio Mata-Marín, Ariane Estrella Weiser Smeke, Mariana Rotzinger Rodriguez, Marcelino Chávez-García, Marco Isaac Banda-Lara, Alma Minerva Pérez Rios, Nohemí Nuñez-Rodríguez, Juan Carlos Domínguez-Hermosillo, Alberto Chaparro Sánchez, Irene Juarez-Kasusky, Javier Enrique Cruz Herrera, Jorge Luis Sandoval Ramírez, Jesús Gaytán-Martínez
OBJECTIVE: We evaluated the effectiveness of a raltegravir (RAL)-containing regimen plus an optimized background regimen in HIV-1 highly treatment-experienced patients. DESIGN: A retrospective cohort, multicentre study was conducted. METHODS: Adult (>16 years old) HIV treatment-experience patients starting therapy with a RAL-containing regimen were included. Effectiveness was evaluated as the percentage of patients with an undetectable HIV-1 RNA viral load (<50 and <200 copies/mL) after 48 weeks, and changes in CD4+ cell counts...
March 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28105610/antithyroid-drug-induced-agranulocytosis-state-of-the-art-on-diagnosis-and-management
#10
Nuno Vicente, Luís Cardoso, Luísa Barros, Francisco Carrilho
Agranulocytosis is a rare but serious complication of antithyroid drug therapy, and an up-to-date understanding of this topic is important. Both direct toxicity and immune-mediated responses have been described as possible mechanisms. Some major susceptibility loci have recently been identified, which may lead the diagnosis of agranulocytosis into a genomic era. Onset is acute and patients present with symptoms and signs of infection together with high fever. Clinical suspicion is pivotal and should prompt blood sampling...
March 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28101837/drug-exposure-and-the-risk-of-microscopic-colitis-a-critical-update
#11
Alfredo J Lucendo
A variety of luminal antigens, including a wide range of drugs, have been associated with the still little-known pathophysiology of microscopic colitis (MC), with variable evidence suggesting causality. This article aims to review the aspects related to drugs as potential triggers of MC; to discuss the most commonly identified associations between drugs and MC; and to analyze the limitations of the studies currently available. A literature search was performed in PubMed combining the search terms 'drug exposure', 'drug consumption', and 'risk factors' with 'microscopic colitis', 'lymphocytic colitis', and 'collagenous colitis', with no language restrictions...
March 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28101836/a-review-of-clinical-outcomes-associated-with-two-meropenem-dosing-strategies
#12
REVIEW
Kyle John Wilby, Ziad Ghantous Nasr, Shereen Elazzazy, Tim T Y Lau, Anas Hamad
Meropenem is a carbapenem antibiotic that exhibits time-dependent bactericidal activity, traditionally dosed intravenously at 1 g every 8 h. In order to maximize its pharmacodynamic activity and reduce costs, an alternative regimen employed by many institutions is 500 mg every 6 h. The objective of this review was to summarize and evaluate published literature comparing clinical outcomes associated with these two meropenem dosing regimens. The literature was searched up to October 2016 using the MEDLINE, EMBASE, and Google Scholar databases...
March 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28078600/net-budgetary-impact-of-ferric-citrate-as-a-first-line-phosphate-binder-for-the-treatment-of-hyperphosphatemia-a-markov-microsimulation-model
#13
Steven M Brunelli, Scott P Sibbel, David Van Wyck, Amit Sharma, Andrew Hsieh, Glenn M Chertow
Ferric citrate (FC) has demonstrated efficacy as a phosphate binder and reduces the requirements for erythropoiesis-stimulating agents (ESAs) and intravenous (IV) iron in dialysis patients. We developed a net budgetary impact model to evaluate FC vs. other phosphate binders from the vantage of a large dialysis provider. We used a Markov microsimulation model to simulate mutually referential longitudinal effects between serum phosphate and phosphate binder dose; categories of these defined health states. Health states probabilistically determined treatment attendance and utilization of ESA and IV iron...
March 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28078599/besifloxacin-ophthalmic-suspension-0-6-compared-with-gatifloxacin-ophthalmic-solution-0-3-for-the-treatment-of-bacterial-conjunctivitis-in-neonates
#14
Christine M Sanfilippo, Catherine M Allaire, Heleen H DeCory
PURPOSE: The aim of this study was to evaluate the safety and efficacy of topical besifloxacin ophthalmic suspension 0.6% compared with gatifloxacin ophthalmic solution 0.3% in the treatment of bacterial conjunctivitis in neonates. METHODS: This was a multicenter, randomized, double-masked, parallel group study. Subjects ≤31 days of age with severity grade ≥1 (scale 0-3) for both conjunctival discharge and conjunctival hyperemia were randomized to besifloxacin or gatifloxacin instilled three times daily for 7 days, and completed five study visits (three clinic visits and two phone calls)...
March 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28074335/clinical-effects-of-topiroxostat-on-renal-and-endothelial-function-in-a-patient-with-chronic-kidney-disease-and-hyperuricemic-arteriolopathy-a-case-report
#15
Atsushi Tanaka, Tsukasa Nakamura, Eiichi Sato, Koichi Node
Hyperuricemia is associated with the progression of chronic kidney disease (CKD) and cardiovascular diseases. Topiroxostat, a selective xanthine oxidase inhibitor, effectively reduces serum uric acid (UA) levels and urinary albumin excretion (UAE) in CKD patients. A 50-year-old Japanese man was referred to our hospital due to albuminuria and hyperuricemia, and renal biopsy showed a typical hyperuricemic arteriolopathy. Treatment with topiroxostat decreased serum UA levels (9.2 mg/dL at baseline to 6.4 mg/dL after 6 months), UAE (388 to 88 mg/g...
March 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28074334/saliva-versus-plasma-bioequivalence-of-azithromycin-in-humans-validation-of-class-i-drugs-of-the-salivary-excretion-classification-system
#16
Nasir Idkaidek, Tawfiq Arafat, Hazim Hamadi, Salim Hamadi, Ibrahim Al-Adham
AIM: The aim of this study was to compare human pharmacokinetics and bioequivalence metrics in saliva versus plasma for azithromycin as a model class I drug of the Salivary Excretion Classification System (SECS). METHODS: A pilot, open-label, two-way crossover bioequivalence study was done, and involved a single 500-mg oral dose of azithromycin given to eight healthy subjects under fasting conditions, followed by a 3-week washout period. Blood and unstimulated saliva samples were collected over 72 h and deep frozen until analysis by a validated liquid chromatography with mass spectroscopy method...
March 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28074333/rosiglitazone-metabolism-in-human-liver-microsomes-using-a-substrate-depletion-method
#17
Maryam Bazargan, David J R Foster, Andrew K Davey, Beverly S Muhlhausler
BACKGROUND: Elimination of rosiglitazone in humans is via hepatic metabolism. The existing studies suggest that CYP2C8 is the major enzyme responsible, with a minor contribution from CYP2C9; however, other studies suggest the involvement of additional cytochrome P450 enzymes and metabolic pathways. Thus a full picture of rosiglitazone metabolism is unclear. OBJECTIVE: This study aimed to improve the current understanding of potential drug-drug interactions and implications for therapy by evaluating the kinetics of rosiglitazone metabolism and examining the impact of specific inhibitors on its metabolism using the substrate depletion method...
March 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28063023/vorapaxar-the-current-role-and-future-directions-of-a-novel-protease-activated-receptor-antagonist-for-risk-reduction-in-atherosclerotic-disease
#18
REVIEW
Rebecca J Gryka, Leo F Buckley, Sarah M Anderson
INTRODUCTION: Despite the current standard of care, patients with cardiovascular disease remain at a high risk for recurrent events. Inhibition of thrombin-mediated platelet activation through protease-activated receptor-1 antagonism may provide reductions in atherosclerotic disease beyond those achievable with the current standard of care. OBJECTIVE: Our primary objective is to evaluate the clinical literature regarding the role of vorapaxar (Zontivity™) in the reduction of cardiovascular events in patients with a history of myocardial infarction and peripheral artery disease...
March 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28063022/identification-of-a-syndrome-class-of-neuropsychiatric-adverse-reactions-to-mefloquine-from-latent-class-modeling-of-fda-adverse-event-reporting-system-data
#19
Remington L Nevin, Jeannie-Marie Leoutsakos
INTRODUCTION: Although mefloquine use is known to be associated with a risk of severe neuropsychiatric adverse reactions that are often preceded by prodromal symptoms, specific combinations of neurologic or psychiatric reactions associated with mefloquine use are not well described in the literature. This study sought to identify a distinct neuropsychiatric syndrome class associated with mefloquine use in reports of adverse events. METHODS: Latent class modeling of US Food and Drug Administration Adverse Event Reporting System (FAERS) data was performed using indicators defined by the Medical Dictionary for Regulatory Activities neurologic and psychiatric high-level group terms, in a study dataset of FAERS reports (n = 5332) of reactions to common antimalarial drugs...
March 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28063021/hepatotoxicity-with-vismodegib-an-md-anderson-cancer-center-and-research-on-adverse-drug-events-and-reports-project
#20
Beatrice J Edwards, Dennis W Raisch, Smita S Saraykar, Ming Sun, Josh A Hammel, Hai T Tran, Nathaniel Wehr, Rasha Arabyat, Dennis P West
BACKGROUND: On 30 January 2012, the US FDA approved vismodegib (Erivedge(®), Genentech, CA, USA) for the management of both metastatic and locally advanced basal cell carcinoma. OBJECTIVE: Our objective was to identify evidence of hepatotoxicity with vismodegib in the FDA Adverse Event Reporting System (FAERS) in treated patients in two National Cancer Institute Comprehensive Cancer Centers. METHODS: FAERS was searched for reports dated 1 January 2009 through 31 December 2015 using terms including hedgehog pathway and vismodegib and hepatic-related terms such as liver, jaundice, and hepatitis, among others...
March 2017: Drugs in R&D
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