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Drugs in R&D

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https://www.readbyqxmd.com/read/28905271/pharmacokinetics-of-a-new-oral-vitamin-d-receptor-activator-2-methylene-19-nor-20s-1%C3%AE-25-dihydroxyvitamin-d3-in-patients-with-chronic-kidney-disease-and-secondary-hyperparathyroidism-on-hemodialysis
#1
Richa Pandey, Julia B Zella, Jinge G Zhu, Lori A Plum, Margaret Clagett-Dame, William J Blaser, Wendy Bedale, Hector F DeLuca, Daniel W Coyne
BACKGROUND: 2-Methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D3 (DP001 or 2MD) is a novel, potent 1α-hydroxylated vitamin D analog that binds to the vitamin D receptor and suppresses parathyroid hormone synthesis and secretion with potential for an improved safety profile compared to existing active vitamin D analogs. The purpose of this study was to evaluate the pharmacokinetics of DP001 given orally after hemodialysis. METHODS: DP001 (550 ng) was given orally to 11 hemodialysis patients with secondary hyperparathyroidism after each dialysis session (3 times/week) for 4 weeks...
September 13, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28905245/identification-of-polymorphic-forms-of-active-pharmaceutical-ingredient-in-low-concentration-dry-powder-formulations-by-synchrotron-x-ray-powder-diffraction
#2
Kenji Egusa, Fumiaki Okazaki, Joerg Schiewe, Ulrike Werthmann, Markus Wolkenhauer
BACKGROUND: The identification of different (pseudo) polymorphs of an active pharmaceutical ingredient in dry powder formulations is of importance during development and entire product lifecycle, e.g., quality control. Whereas determination of polymorphic differences of pure substances is rather easy, in dry powder formulations, it is generally difficult and the difficulties increase particularly, if the substance of interest is present only in low concentrations in the formulation. Such a formulation is Spiriva(®) inhalation powder (Boehringer Ingelheim), which contains only 0...
September 13, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28895069/feasibility-safety-and-efficacy-of-an-alternative-schedule-of-sunitinib-for-the-treatment-of-patients-with-metastatic-renal-cell-carcinoma-a-retrospective-study
#3
Sebastiano Buti, Maddalena Donini, Melissa Bersanelli, Alessia Gattara, Francesco Leonardi, Rodolfo Passalacqua
BACKGROUND: Standard treatment with sunitinib for patients with metastatic renal cancer provides an 'on-off' schedule (daily administration of a 50-mg capsule for 4 weeks, followed by a 2-week break; consecutive 6-week cycles). We developed an alternative intermittent schedule to reduce the toxicity and symptoms of tumor regrowth during the rest period and to allow prolonged continuation of therapy, maintaining dose intensity. OBJECTIVE: The objective of this study was to provide a retrospective evaluation of the feasibility, safety, and efficacy of an alternative schedule of sunitinib in patients who did not tolerate classical treatment...
September 11, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28879645/pharmacokinetic-effects-of-antidrug-antibodies-occurring-in-healthy-subjects-after-a-single-dose-of-intravenous-infliximab
#4
Eli D Ehrenpreis
BACKGROUND: Infliximab pharmacokinetic studies have been performed in patients receiving chronic infliximab therapy. In these patients, infliximab antidrug antibodies (ADAs) increase infliximab clearance and decrease serum levels and drug efficacy. OBJECTIVE: This study analyzed the pharmacokinetic effect of infliximab ADAs in healthy subjects receiving a single dose of intravenous infliximab. METHODS: Data were obtained from a single-blind, parallel-group, single-dose study of healthy subjects receiving 5 mg/kg of intravenous SB2 (infliximab biosimilar), EU-sourced Remicade (EU-IFX) or US-sourced Remicade (US-IFX)...
September 6, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28879638/impact-of-etoposide-on-brca1-expression-in-various-breast-cancer-cell-lines
#5
Xi Zhang, Simone Hofmann, Nadia Harbeck, Udo Jeschke, Sophie Sixou
Breast cancer 1 (BRCA1), as a tumor suppressor, exerts an effective influence on protecting DNA integrity to suppress the development of breast cancer (BC). BRCA1 expression is induced in response to DNA-damaging agents such as etoposide. Germline BRCA1 gene mutations are associated with development of hereditary BC. However, besides BRCA-mutated BCs, some sporadic cancers may also exhibit a BRCA-like phenotype, displaying so-called 'BRCAness'. This common phenotype may respond to similar therapeutic approaches as BRCA-mutated tumors and may thus have important implications for the clinical management of these cancers...
September 6, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28879584/adverse-event-profile-of-pyrimethamine-based-therapy-in-toxoplasmosis-a-systematic-review
#6
REVIEW
Ruben R Ben-Harari, Elizabeth Goodwin, Julio Casoy
INTRODUCTION: Approximately a third of the population worldwide is chronically infected with Toxoplasma gondii. Pyrimethamine-based regimens are recommended for the treatment of toxoplasmosis. OBJECTIVE: The aim was to evaluate the safety profile of pyrimethamine-based treatment for the three main Toxoplasma manifestations: toxoplasmic encephalitis (TE), ocular toxoplasmosis, and congenital toxoplasmosis. METHODS: PubMed, Cochrane Library, and Google Scholar databases were searched through August 1, 2016...
September 6, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28875397/boceprevir-and-antiretroviral-pharmacokinetic-interactions-in-hiv-hcv-co-infected-persons-aids-clinical-trials-group-study-a5309s
#7
Jennifer J Kiser, Darlene Lu, Susan L Rosenkranz, Gene D Morse, Robin DiFrancesco, Kenneth E Sherman, Adeel A Butt
OBJECTIVE: The objective of this study was to determine the magnitude of drug interactions between the hepatitis C virus (HCV) protease inhibitor boceprevir (BOC) and antiretroviral (ARV) agents in persons with HIV/HCV co-infection. METHODS: Participants taking two nucleos(t)ide analogs with either efavirenz, raltegravir, or ritonavir-boosted atazanavir, darunavir, or lopinavir underwent intensive pharmacokinetic (PK) sampling for ARV 2 weeks before (week 2) and 2 weeks after initiating BOC (week 6) and for BOC at week 6...
September 5, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28865038/benzodiazepines-and-z-drugs-an-updated-review-of-major-adverse-outcomes-reported-on-in-epidemiologic-research
#8
REVIEW
Jaden Brandt, Christine Leong
Various adverse events resulting from, or associated with, benzodiazepine and/or Z-drug use have been extensively reported on and discussed in great detail within the biomedical literature. It is widely accepted that motor vehicle accidents and falls leading to fractures in older adults are major adverse events that have been shown to occur more frequently in users of sedative-hypnotic medication, especially of the benzodiazepine and related Z-drug variety. However, the last few years have seen increasing reports in the literature raising the issue of benzodiazepine and Z-drug exposure in the development of other serious medical issues including dementia, infections, respiratory disease exacerbation, pancreatitis, and cancer...
September 1, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28831752/longitudinal-assessment-of-the-effect-of-atrasentan-on-thoracic-bioimpedance-in-diabetic-nephropathy-a-randomized-double-blind-placebo-controlled-trial
#9
David J Webb, Blai Coll, Hiddo J L Heerspink, Dennis Andress, Yili Pritchett, John J Brennan, Mark Houser, Ricardo Correa-Rotter, Donald Kohan, Hirofumi Makino, Vlado Perkovic, Giuseppe Remuzzi, Sheldon W Tobe, Robert Toto, Robert Busch, Pablo Pergola, Hans-Henrik Parving, Dick de Zeeuw
BACKGROUND: Fluid retention is a common adverse event in patients who receive endothelin (ET) receptor antagonist therapy, including the highly selective ETA receptor antagonist, atrasentan. OBJECTIVE: We performed longitudinal assessments of thoracic bioimpedance in patients with type 2 diabetes mellitus and nephropathy to determine whether a decrease in bioimpedance accurately reflected fluid retention during treatment with atrasentan. STUDY DESIGN: We conducted a randomized, double-blind, placebo-controlled study in 48 patients with type 2 diabetes mellitus and nephropathy who were receiving stable doses of renin angiotensin system inhibitors and diuretics...
August 22, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28828595/the-egfr-inhibitor-gefitinib-enhanced-the-response-of-human-oral-squamous-cell-carcinoma-to-cisplatin-in-vitro
#10
Ashraf Khalil, Mark J Jameson
INTRODUCTION: The epidermal growth factor receptor (EGFR) is highly expressed in a variety of solid tumors including oral cavity squamous cell carcinoma (OSCC) and has been implicated in the resistance of these tumors to cisplatin. This study was performed to determine if the EGFR tyrosine kinase inhibitor gefitinib could enhance the cytotoxic effect of cisplatin on OSCC cells in vitro. METHODS: The expression of EGFR and the phosphorylation of its downstream signaling to ERK, and AKT pathway were detected by Western blotting...
August 21, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28815425/methodological-study-of-vancomycin-dosing-in-elderly-patients-using-actual-serum-creatinine-versus-rounded-serum-creatinine
#11
Tramaine Young, Matt Daniel, Stephanie Baumhover, Duke Eidson, Jane Green
PURPOSE: The practice of intentional rounding up of serum creatinine (SCr) in elderly patients with low measured values can lead to an underestimation of creatinine clearance and subsequent inaccurate dosing of medications. Thus, the purpose of this study was to evaluate the accuracy of vancomycin dose calculations for patients aged ≥65 years using an SCr rounded up to 1 mg/dL versus actual SCr. METHODS: This study compared the difference between measured steady-state vancomycin trough concentrations with predicted trough concentrations that have been calculated using rounded SCr and actual SCr...
August 16, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28801802/does-dose-modification-affect-efficacy-of-first-line-pazopanib-in-metastatic-renal-cell-carcinoma
#12
Paolo Grassi, Elena Verzoni, Raffaele Ratta, Luca Porcu, Michele Prisciandaro, Alessia Mennitto, Giuseppina Calareso, Filippo de Braud, Giuseppe Procopio
BACKGROUND: Pazopanib is a standard treatment for metastatic renal cell carcinoma (mRCC), and 800 mg/daily is considered the optimal dose. However, some patients require dose modification because of toxicity. Whether a reduced dose of pazopanib is as effective as the standard dose in achieving clinical benefit remains unclear. OBJECTIVES: Our objective was to conduct a retrospective analysis to investigate the clinical effect of different therapeutic doses of first-line pazopanib in patients with mRCC...
August 11, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28776237/differences-in-dihydrotetrabenazine-isomer-concentrations-following-administration-of-tetrabenazine-and-valbenazine
#13
Heather Skor, Evan B Smith, Gordon Loewen, Christopher F O'Brien, Dimitri E Grigoriadis, Haig Bozigian
BACKGROUND: Tetrabenazine (TBZ) activity is thought to result from four isomeric dihydrotetrabenazine (HTBZ) metabolites ([+]-α-HTBZ, [-]-α-HTBZ, [+]-β-HTBZ, [-]-β-HTBZ). Each isomer has a unique profile of vesicular monoamine transporter 2 (VMAT2) inhibition and off-target binding. Previously published data only report total isomer (α) and (β) concentrations. We developed a method to quantify the individual HTBZ isomers in samples from patients with Huntington's disease receiving TBZ...
August 3, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28756607/a-randomized-open-label-two-way-crossover-single-dose-bioequivalence-study-of-temozolomide-200%C3%A2-mg-m-2-dralitem-%C3%A2-vs-temodal-%C3%A2-capsules-in-patients-with-primary-tumors-of-the-central-nervous-system-under-fasting-conditions
#14
Alejandro Muggeri, Miguel Vago, Sebastián Pérez, Marcelo Rubio, Cecilia González, Cristian Magariños, Mónica Rosenberg, Fernando Costa, Santiago Pérez-Lloret
BACKGROUND: Temozolomide is an antineoplastic agent of proven efficacy against high-grade gliomas. PURPOSE: The objective of this crossover, single-dose, bioequivalence study was to compare the rate and extent of absorption of oral temozolomide after administration of the study product (Dralitem(®), Monte Verde Sociedad Anónima) and the reference product (Temodal(®), originator product manufactured by Schering Plough Laboratories) in patients with primary central nervous system (CNS) tumors under fasting conditions...
July 29, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28748348/impact-of-genetic-polymorphisms-on-phenytoin-pharmacokinetics-and-clinical-outcomes-in-the-middle-east-and-north-africa-region
#15
REVIEW
Renée Dagenais, Kyle John Wilby, Hazem Elewa, Mary H H Ensom
BACKGROUND: Genetic polymorphisms are known to influence outcomes with phenytoin yet effects in the Middle East and North Africa region are poorly understood. OBJECTIVES: The objective of this systematic review was to evaluate the impact of genetic polymorphisms on phenytoin pharmacokinetics and clinical outcomes in populations originating from the Middle East and North Africa region, and to characterize genotypic and allelic frequencies within the region for genetic polymorphisms assessed...
July 26, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28744772/breakthrough-pain-management-with-sublingual-fentanyl-tablets-in-patients-with-cancer-age-subgroup-analysis-of-a-multicenter-prospective-study
#16
Jordi Guitart, María Isabel Vargas, Vicente De Sanctis, Jordi Folch, Rafael Salazar, José Fuentes, Joan Coma, Julia Ferreras, Jordi Moya, Albert Tomás, Pere Estivill, Francisco Rodelas, Antonio Javier Jiménez, Almudena Sanz
INTRODUCTION: Breakthrough pain (BTP) management in patients with cancer is challenging, especially in the elderly. However, no studies examining the influence of age on BTP medication have been conducted. The aim of this work was to investigate the effect of sublingual fentanyl tablets (SFTs) in terms of efficacy, safety, and quality of life in two age categories. METHODS: We performed age subgroup analyses (<65 and ≥65 years) from a recently completed study conducted in Spain...
July 25, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28741150/eslicarbazepine-acetate-a-new-improvement-on-a-classic-drug-family-for-the-treatment-of-partial-onset-seizures
#17
REVIEW
Graciana L Galiana, Angela C Gauthier, Richard H Mattson
Eslicarbazepine acetate is a new anti-epileptic drug belonging to the dibenzazepine carboxamide family that is currently approved as adjunctive therapy and monotherapy for partial-onset (focal) seizures. The drug enhances slow inactivation of voltage-gated sodium channels and subsequently reduces the activity of rapidly firing neurons. Eslicarbazepine acetate has few, but some, drug-drug interactions. It is a weak enzyme inducer and it inhibits cytochrome P450 2C19, but it affects a smaller assortment of enzymes than carbamazepine...
July 24, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28667384/effectiveness-and-safety-of-switching-from-innovator-infliximab-to-biosimilar-ct-p13-in-inflammatory-rheumatic-diseases-a-real-world-case-study
#18
Cristina Vergara-Dangond, Marina Sáez Belló, Mónica Climente Martí, Pilar Llopis Salvia, Juan José Alegre-Sancho
OBJECTIVE: CT-P13 is a biosimilar with comparable pharmacokinetics, efficacy and safety to its reference product (RP), infliximab. Studies have shown that switching from RP to CT-P13 does not reduce the effectiveness or safety of treatment. METHODS: In this retrospective real-world study, patients with inflammatory diseases treated with RP were switched to CT-P13 (n = 7) or continued on RP (n = 6). Clinical outcomes were compared between groups after four treatment cycles...
June 30, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28646384/lipophilicity-influences-drug-binding-to-%C3%AE-1-acid-glycoprotein-f1-s-variants-but-not-to-the-a-variant
#19
Kazuhiko Hanada
OBJECTIVE: Human α1-acid glycoprotein has genetic variants, the F1, S, and A variants, which can be separated isoelectrophoretically. These variants show differences in their affinity of binding to several drugs. In this study, we investigated the factors determining drug binding to these α1-acid glycoprotein genetic variants using disopyramide, warfarin, and tamsulosin as marker compounds. METHODS: Binding of the marker drugs to human α1-acid glycoprotein was determined by ultra-filtration in the presence or absence of various other drugs...
June 23, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28580512/comparative-effect-of-calcium-channel-blockers-on-glomerular-function-in-hypertensive-patients-with-diabetes-mellitus
#20
Yayoi Nishida, Yasuo Takahashi, Kotoe Tezuka, Satoshi Takeuchi, Tomohiro Nakayama, Satoshi Asai
BACKGROUND: We conducted a retrospective cohort study to evaluate and compare the longitudinal effect of monotherapy with L-, L/T-, L/N-, and L/N/T-type calcium channel blockers (CCBs) on estimated glomerular filtration rate (eGFR), and to investigate the association of treatment duration with eGFR in diabetic patients with hypertension. METHODS: Using a clinical database, we identified new users of five CCBs, i.e. amlodipine (L-type, n = 693), nifedipine (L-type, n = 189), azelnidipine (L/T-type, n = 91), benidipine (L/N/T-type, n = 183), and cilnidipine (L/N-type, n = 61)...
June 3, 2017: Drugs in R&D
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