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Drugs in R&D

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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
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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/28547536/a-comparative-study-of-the-hemoglobin-maintaining-effects-between-epoetin-%C3%AE-pegol-and-darbepoetin-%C3%AE-in-patients-with-chronic-kidney-disease-during-3%C3%A2-months-before-dialysis-initiation
#8
Satoru Oka, Yoko Obata, Kenta Torigoe, Miki Torigoe, Shinichi Abe, Kumiko Muta, Yuki Ota, Mineaki Kitamura, Satoko Kawasaki, Misaki Hirose, Tadashi Uramatsu, Hiroshi Yamashita, Hideyuki Arai, Hiroshi Mukae, Tomoya Nishino
BACKGROUND AND OBJECTIVE: We compared the hemoglobin-maintaining effects between continuous erythropoietin receptor activator (CERA) and darbepoetin-α (DA) in patients with chronic kidney disease (CKD) during the 3 months before dialysis initiation. METHODS: This study was conducted with 37 CERA-administered patients and 26 DA-administered patients who had initiated dialysis at a participating facility between January 2012 and December 2014. We investigated clinical laboratory data 3 months before and at dialysis initiation, and compared these data between the CERA and DA groups...
May 25, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28528515/comment-on-net-budgetary-impact-of-ferric-citrate-as-a-first-line-phosphate-binder-for-the-treatment-of-hyperphosphatemia-a-markov-microsimulation-mode
#9
LETTER
https://www.readbyqxmd.com/read/28516342/pharmacokinetic-bioequivalence-studies-of-an-extended-release-oxycodone-hydrochloride-tablet-in-healthy-japanese-subjects-under-fasting-and-fed-conditions-without-an-opioid-antagonist
#10
Kaoru Toyama, Hidetoshi Furuie, Kana Kuroda, Hitoshi Ishizuka
Oxycodone is a semisynthetic opioid used for the treatment of moderate to severe pain. Two separate studies were conducted to assess the pharmacokinetic bioequivalence of a newly formulated oxycodone hydrochloride extended-release tablet to a marketed oxycodone product in Japan under fasting and fed conditions. Each study was a randomized, open-label, single-dose, single-center, two-period, two-way crossover study. Healthy male Japanese subjects received the oxycodone 10-mg products under fasting and fed conditions...
May 17, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28470465/solubilization-and-stability-of-mitomycin-c-solutions-prepared-for-intravesical-administration
#11
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
#12
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
#13
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
#14
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
#15
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
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
#16
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...
June 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28258478/in-vitro-diagnosis-of-immediate-drug-hypersensitivity-anno-2017-potentials-and-limitations
#17
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)...
June 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28229376/the-pharmacogenetics-of-tacrolimus-in-corticosteroid-sparse-pediatric-and-adult-kidney-transplant-recipients
#18
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...
June 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
#19
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...
June 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
#20
MULTICENTER STUDY
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
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