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Drugs in R&D

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https://www.readbyqxmd.com/read/28828595/the-egfr-inhibitor-gefitinib-enhanced-the-response-of-human-oral-squamous-cell-carcinoma-to-cisplatin-in-vitro
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
https://www.readbyqxmd.com/read/28577294/comparison-of-generic-drug-reviews-for-marketing-authorization-between-japan-and-canada
#12
Ryosuke Kuribayashi, Scott Appleton
PURPOSE: Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. OBJECTIVE: The objective of this study was to examine generic drug reviews in Japan and Canada. METHODS: We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms...
June 2, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28577293/pharmacokinetics-of-bevacizumab-in-three-patients-under-the-age-of-3%C3%A2-years-with-cns-malignancies
#13
Johannes Gojo, Robert Sauermann, Ursula Knaack, Irene Slavc, Andreas Peyrl
BACKGROUND: Bevacizumab is a recombinant antibody that is increasingly used in pediatric malignancies. The pharmacokinetics of bevacizumab in pediatric patients have been shown to be influenced by tumor localization and body weight. In this report, we present data on the pharmacokinetics and safety of bevacizumab in children under the age of 3 years with central nervous system (CNS) malignancies. METHODS: Three patients (mean age 22 months) were treated with intravenous bevacizumab 10 mg/kg every 2 weeks...
June 2, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28577292/a-dipeptidyl-peptidase-4-inhibitor-teneligliptin-decreases-plasma-triglyceride-rich-lipoprotein-remnants-in-diabetic-patients-with-chronic-kidney-disease-undergoing-hemodialysis
#14
Koichiro Homma, Joe Yoshizawa, Yutaka Shiina, Hideki Ozawa, Muneki Igarashi, Tadashi Matsuoka, Junichi Sasaki, Mamoru Yoshizawa, Yasuhiko Homma
OBJECTIVE: A high plasma level of remnant-like particle cholesterol (RLP-C), which is equivalent to triglyceride-rich lipoprotein remnant, is an important coronary risk marker. RLP-C level is high, independent of other plasma lipids, in patients with chronic kidney disease (CKD) undergoing hemodialysis. The effect of teneligliptin, a dipeptidyl peptidase (DPP)-4 inhibitor, on plasma levels of RLP-C in patients with diabetes mellitus and CKD under hemodialysis was studied. METHODS: Teneligliptin 20 mg/day was administered to 15 patients with diabetes and CKD undergoing hemodialysis for 12 weeks...
June 2, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28573606/a-phase-i-study-of-combination-therapy-with-sorafenib-and-5-fluorouracil-in-patients-with-advanced-hepatocellular-carcinoma
#15
Takuya Sho, Mitsuru Nakanishi, Kenichi Morikawa, Masatsugu Ohara, Naoki Kawagishi, Takaaki Izumi, Machiko Umemura, Jun Ito, Masato Nakai, Goki Suda, Koji Ogawa, Makoto Chuma, Takashi Meguro, Michio Nakamura, Atsushi Nagasaka, Hiromasa Horimoto, Yoshiya Yamamoto, Naoya Sakamoto
BACKGROUND AND AIMS: Sorafenib is the first molecular targeted drug approved for the treatment of advanced hepatocellular carcinoma (HCC) and is a potent small molecule inhibitor of multiple kinases. Combination therapy with sorafenib and other cytotoxic agents for HCC may result in additive anticancer activity. The purpose of this phase I study was to investigate the safety and tolerability of combination therapy with sorafenib and 5-fluorouracil (5-FU) and to determine the optimum dose of 5-FU for a phase II trial...
June 1, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28470465/solubilization-and-stability-of-mitomycin-c-solutions-prepared-for-intravesical-administration
#16
Alan L Myers, Yan-Ping Zhang, Jitesh D Kawedia, Ximin Zhou, Stacey M Sobocinski, Michael J Metcalfe, Mark A Kramer, Colin P N Dinney, Ashish M Kamat
BACKGROUND: Mitomycin C (MMC) is an antitumor agent that is often administered intravesically to treat bladder cancer. Pharmacologically optimized studies have suggested varying methods to optimize delivery, with drug concentration and solution volume being the main drivers. However, these MMC concentrations (e.g. 2.0 mg/mL) supersede its solubility threshold, raising major concerns of inferior drug delivery. OBJECTIVE: In this study, we seek to confirm that the pharmacologically optimized MMC concentrations are achievable in clinical practice through careful modifications of the solution preparation methods...
June 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28389998/psychotropic-drug-related-fall-incidents-in-nursing-home-residents-living-in-the-eastern-part-of-the-netherlands
#17
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...
June 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
#18
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(®)...
June 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28324583/revisiting-cdk-inhibitors-for-treatment-of-glioblastoma-multiforme
#19
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...
June 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28299646/hyperlipidemia-alters-the-pharmacokinetics-of-posaconazole-and-vincristine-upon-co-administration-in-rats
#20
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...
June 2017: Drugs in R&D
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