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https://www.readbyqxmd.com/read/28632830/-declaration-of-the-chilean-academy-of-medicine-of-law-20-850-on-clinical-trials-of-pharmaceutical-products-and-medical-devices-and-of-the-bylaw-that-will-regulate-its-application
#1
Gloría López, Gloría Valdés, Emilio Roessler, Vicente Valdivieso
In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will endanger local interest in front-line research: 1) The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2) The 10 year period during which any adverse event is assumed to have been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3) Individuals submitted to the trials are entitled to free post trial access to the treatment received during the study, financed by the trial supporting entities and as long as the drug or devise is considered to be useful...
April 2017: Revista Chilena de Infectología: órgano Oficial de la Sociedad Chilena de Infectología
https://www.readbyqxmd.com/read/28628923/cremophor-el-alters-the-plasma-protein-binding-and-pharmacokinetic-profile-of-valspodar-in-rats
#2
Ziyad Binkhathlan
Cremophor EL is a nonionic surfactant widely used in pharmaceutical formulations. Nonetheless, there are several reports on the influence of this excipient on the protein binding, pharmacokinetics, and pharmacodynamics of drugs. Valspodar is an investigational non-immunosuppressive derivative of cyclosporine A, used in clinical trials for treatment of multidrug resistant tumors. The formulation of valspodar (Amdray(®)) contains cremophor EL and ethanol as solubilizing agents. The main aim of the current study was to assess the plasma protein binding (in vitro) and the pharmacokinetic profile of valspodar in the cremophor EL-based formulation in comparison to a cremophor EL-free formulation following intravenous (i...
June 19, 2017: Drug Research
https://www.readbyqxmd.com/read/28628225/utilization-of-the-bridging-strategy-for-the-development-of-new-drugs-in-oncology-to-avoid-drug-lag
#3
Seiji Kogure, Nobuyuki Koyama, Shinji Hidaka
Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style...
June 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28625625/economic-burden-of-clinical-trials-in-lung-cancer-in-a-german-comprehensive-cancer-center
#4
F Kron, A Kostenko, M Scheffler, D Müller, J-P Glossmann, R Fischer, S Michels, L Nogova, M Hallek, T Zander, J Wolf
OBJECTIVES: The recent success of individualized lung cancer therapy has triggered fundamental changes in clinical research strategies. To date there is a strong focus on early proof of concept trials in genetically preselected small patient subgroups. This analysis focuses on the economic burden caused by such trials for advanced lung cancer patients in a German Comprehensive Cancer Center (CCC). METHODS: The profit margins between recruiting groups with ≤3 and >3 patients were compared...
June 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28624775/complexing-agents-and-ph-influence-on-chemical-durability-of-type-i-moulded-glass-containers
#5
Alberto Biavati, Michele Poncini, Arianna Ferrarini, Nicola Favaro, Martina Scarpa, Marta Vallotto
Among the factors that affect the glass surface chemical durability, pH and complexing agents presence in aqueous solution have the main role (1). Glass surface attack can be also related to the delamination issue with glass particles appearance in the pharmaceutical preparation. A few methods to check for glass containers delamination propensity and some control guidelines have been proposed (2,3). The present study emphasizes the possible synergy between a few complexing agents with pH on the borosilicate glass chemical durability...
June 16, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28622912/clinical-approaches-to-the-development-of-a-neuroprotective-therapy-for-pd
#6
REVIEW
C W Olanow, K Kieburtz, R Katz
The development of a neuroprotective or disease-modifying therapy is the major unmet need in the management of Parkinson's Disease (PD) and the goal of much clinical and scientific research. However, despite enormous efforts and expense, no disease-modifying therapy for PD has been approved to date. Historically attempts to define such a therapy have been limited by confounding symptomatic/pharmacologic effects of the study intervention and the lack of a clear and well-defined regulatory and clinical development pathway that leads to a disease-modifying indication...
June 13, 2017: Experimental Neurology
https://www.readbyqxmd.com/read/28619938/kilogram-scale-prexasertib-monolactate-monohydrate-synthesis-under-continuous-flow-cgmp-conditions
#7
Kevin P Cole, Jennifer McClary Groh, Martin D Johnson, Christopher L Burcham, Bradley M Campbell, William D Diseroad, Michael R Heller, John R Howell, Neil J Kallman, Thomas M Koenig, Scott A May, Richard D Miller, David Mitchell, David P Myers, Steven S Myers, Joseph L Phillips, Christopher S Polster, Timothy D White, Jim Cashman, Declan Hurley, Robert Moylan, Paul Sheehan, Richard D Spencer, Kenneth Desmond, Paul Desmond, Olivia Gowran
Advances in drug potency and tailored therapeutics are promoting pharmaceutical manufacturing to transition from a traditional batch paradigm to more flexible continuous processing. Here we report the development of a multistep continuous-flow CGMP (current good manufacturing practices) process that produced 24 kilograms of prexasertib monolactate monohydrate suitable for use in human clinical trials. Eight continuous unit operations were conducted to produce the target at roughly 3 kilograms per day using small continuous reactors, extractors, evaporators, crystallizers, and filters in laboratory fume hoods...
June 16, 2017: Science
https://www.readbyqxmd.com/read/28619000/astrocytes-pathology-in-als-a-potential-therapeutic-target
#8
Sonja Johann
The mechanisms underlying neurodegeneration in amyotrophic lateral sclerosis (ALS) are multifactorial and include genetic and environmental factors. Nowadays, it is well accepted that neuronal loss is driven by non-cell autonomous toxicity. Non-neuronal cells, such as astrocytes, have been described to significantly contribute to motoneuron cell death and disease progression in cell culture experiments and animal models of ALS. Astrocytes are essential for neuronal survival and function by regulating neurotransmitter and ion homeostasis, immune response, blood flow and glucose uptake, antioxidant defence and growth factor release...
June 15, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28617255/a-harmonized-and-efficient-clinical-research-environment-would-benefit-patients-and-enhance-european-competitiveness-commentary
#9
Antonino Amato, Eugenio Aringhieri, Stefania Boccia, Filippo Buccella, Barbara Gorini, Donatella Gramaglia, Riccardo Masetti, Paolo Rossi, Pier Giuseppe Pelicci
The forthcoming implementation of the European Clinical Trial Regulation (Regulation (EU) No. 536/2014), which is expected to facilitate the conduct of clinical trials across the European Union, will require National Authorities to create the best conditions for the implementation of the new Regulation through national guidelines, so that sponsors may reconsider Europe as a prime location for planning clinical trials. During a meeting titled "Innovation in Clinical Research", an expert panel discussed potential local advances fostering competitiveness of European clinical research with representatives of the pharmaceutical industry, patient organisations and Italian regulatory agency in view of the forthcoming implementation of (EU) No...
April 2017: Annali Dell'Istituto Superiore di Sanità
https://www.readbyqxmd.com/read/28614452/-profile-of-clinical-trials-enrolling-brazilian-children
#10
Jean Mendes de Lucena Vieira, Elisangela da Costa Lima, Marcelo Gerardin Poirot Land, Miriam Ventura, Helena Lutescia Luna Coelho
This study aimed to characterize the clinical trials with medicines enrolling Brazilian children and adolescents, registered in the databases of Clinical Trials and the Brazilian Clinical Trials Network (ReBEC) from 1994 to 2014. Only 462 clinical trials enrolled Brazilian children and adolescents. There was an increase in registrations beginning in 2003, with an important drop in 2011. Among these trials, 35.5% were hosted in Brazil. The international clinical trials were mostly conducted by North American companies...
June 12, 2017: Cadernos de Saúde Pública
https://www.readbyqxmd.com/read/28611391/isothiocyanates-are-detected-in-human-synovial-fluid-following-broccoli-consumption-and-can-affect-the-tissues-of-the-knee-joint
#11
Rose Davidson, Sarah Gardner, Orla Jupp, Angela Bullough, Sue Butters, Laura Watts, Simon Donell, Maria Traka, Shikha Saha, Richard Mithen, Mandy Peffers, Peter Clegg, Yongping Bao, Aedin Cassidy, Ian Clark
Osteoarthritis is a major cause of disability and there is no current pharmaceutical treatment which can prevent the disease or slow its progression. Dietary advice or supplementation is clearly an attractive option since it has low toxicity and ease of implementation on a population level. We have previously demonstrated that sulforaphane, a dietary isothiocyanate derived from its glucosinolate precursor which is found in broccoli, can prevent cartilage destruction in cells, in in vitro and in vivo models of osteoarthritis...
June 13, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28610802/herbal-medicine-in-children-with-respiratory-tract-infection-systematic-review-and-meta-analysis
#12
REVIEW
Dennis Anheyer, Holger Cramer, Romy Lauche, Felix Joyonto Saha, Gustav Dobos
BACKGROUND: Herbal medicines are particularly regarded as an alternative or complement to conventional pharmaceuticals in the treatment and prevention of respiratory tract infections (RTI). OBJECTIVE: Therefore the purpose of this review was to identify evidence for herbal therapy in the treatment of RTI concerning effectiveness and safety. DATA SOURCES: Medline/PubMed, Scopus and the Cochrane Library were searched through 12 February 2015...
June 10, 2017: Academic Pediatrics
https://www.readbyqxmd.com/read/28606620/efficacy-and-safety-of-lumacaftor-and-ivacaftor-in-patients-aged-6-11-years-with-cystic-fibrosis-homozygous-for-f508del-cftr-a-randomised-placebo-controlled-phase-3-trial
#13
Felix Ratjen, Christopher Hug, Gautham Marigowda, Simon Tian, Xiaohong Huang, Sanja Stanojevic, Carlos E Milla, Paul D Robinson, David Waltz, Jane C Davies
BACKGROUND: Lumacaftor and ivacaftor combination treatment showed efficacy in patients aged 12 years or older with cystic fibrosis homozygous for F508del-cystic fibrosis transmembrane conductance regulator (CFTR) in placebo-controlled studies and patients aged 6-11 years with cystic fibrosis homozygous for F508del-CFTR in an open-label study. We report efficacy and safety of lumacaftor and ivacaftor in patients with cystic fibrosis aged 6-11 years homozygous for F508del-CFTR. METHODS: In this phase 3, randomised, double-blind, placebo-controlled, multicentre study, patients were enrolled at 54 hospitals and medical centres in nine countries (the USA, Australia, Belgium, Canada, Denmark, France, Germany, Sweden, and the UK)...
June 8, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28603635/clinical-trial-allocation-in-multinational-pharmaceutical-companies-a-qualitative-study-on-influential-factors
#14
Tilde Dombernowsky, Merete Haedersdal, Ulrik Lassen, Simon F Thomsen
Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were (1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting trial sites...
June 2017: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28602779/ceritinib-versus-chemotherapy-in-patients-with-alk-rearranged-non-small-cell-lung-cancer-previously-given-chemotherapy-and-crizotinib-ascend-5-a-randomised-controlled-open-label-phase-3-trial
#15
Alice T Shaw, Tae Min Kim, Lucio Crinò, Cesare Gridelli, Katsuyuki Kiura, Geoffrey Liu, Silvia Novello, Alessandra Bearz, Oliver Gautschi, Tony Mok, Makoto Nishio, Giorgio Scagliotti, David R Spigel, Stéphanie Deudon, Cheng Zheng, Serafino Pantano, Patrick Urban, Cristian Massacesi, Kalyanee Viraswami-Appanna, Enriqueta Felip
BACKGROUND: Ceritinib is a next-generation anaplastic lymphoma kinase (ALK) inhibitor, which has shown robust anti-tumour efficacy, along with intracranial activity, in patients with ALK-rearranged non-small-cell lung cancer. In phase 1 and 2 studies, ceritinib has been shown to be highly active in both ALK inhibitor-naive and ALK inhibitor-pretreated patients who had progressed after chemotherapy (mostly multiple lines). In this study, we compared the efficacy and safety of ceritinib versus single-agent chemotherapy in patients with advanced ALK-rearranged non-small-cell lung cancer who had previously progressed following crizotinib and platinum-based doublet chemotherapy...
June 8, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28601936/acute-kidney-injury-emerging-pharmacotherapies-in-current-clinical-trials
#16
Stefanie Woolridge Benoit, Prasad Devarajan
Acute kidney injury (AKI) is a significant source of morbidity and mortality in pediatric patients, affecting more than one quarter of critically ill children. Despite significant need, there are no targeted therapies to reliably prevent or treat AKI. Recent advances in our understanding of renal injury and repair signaling pathways have enabled the development of several targeted pharmaceuticals. Here we review emerging pharmacotherapies for AKI that are currently in clinical trials. Categorized by their general mechanism of action, the therapies discussed include anti-inflammatory agents (recAP, AB103, ABT-719), antioxidants (iron chelators, heme arginate), vasodilators (levosimendan), apoptosis inhibitors (QPI-1002), and repair agents (THR-184, BB-3, mesenchymal stem cells)...
June 10, 2017: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
https://www.readbyqxmd.com/read/28601837/development-of-a-core-outcome-set-for-clinical-trials-in-inflammatory-bowel-disease-study-protocol-for-a-systematic-review-of-the-literature-and-identification-of-a-core-outcome-set-using-a-delphi-survey
#17
Christopher Ma, Remo Panaccione, Richard N Fedorak, Claire E Parker, Reena Khanna, Barrett G Levesque, William J Sandborn, Brian G Feagan, Vipul Jairath
INTRODUCTION: Crohn's disease (CD) and ulcerative colitis (UC), the main forms of inflammatory bowel disease (IBD), are chronic, progressive and disabling disorders of the gastrointestinal tract. Although data from randomised controlled trials (RCTs) provide the foundation of evidence that validates medical therapy for IBD, considerable heterogeneity exists in the measured outcomes used in these studies. Furthermore, in recent years, there has been a paradigm shift in IBD treatment targets, moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance, inflammatory biomarkers and histological and radiographic end points...
June 9, 2017: BMJ Open
https://www.readbyqxmd.com/read/28601545/red-yeast-rice-preparations-are-they-suitable-substitutions-for-statins
#18
REVIEW
Carlos A Dujovne
Red yeast rice, a commercially available food supplement known to reduce serum cholesterol, has been repeatedly advocated as alternative therapy for hypercholesterolemic patients that refuse statins, cannot tolerate statin therapy's side effects, or request a "naturopathic" medicine. Red yeast rice contains a fungus (Monascus purpureus), which was utilized in the original production of lovastatin (Mevacor TM), the first marketed pharmaceutical statin, and is chemically identical to such product. Their identical properties account for the similarity in therapeutic and side effects of red yeast rice and lovastatin...
June 7, 2017: American Journal of Medicine
https://www.readbyqxmd.com/read/28601256/aurora-a-kinase-is-a-priority-pharmaceutical-target-for-the-treatment-of-cancers
#19
REVIEW
Arun Prasath Damodaran, Lucie Vaufrey, Olivia Gavard, Claude Prigent
Aurora kinases control multiple events during cell cycle progression and are essential for mitotic and meiotic bipolar spindle assembly and function. There are three Aurora kinases in mammals, some of which have oncogenic properties and all of which are overexpressed in multiple cancers. Pharmaceutical companies quickly made these kinases priority targets for the development of inhibitors to be used as cancer treatments. In this review, we focus on Aurora A, against which several inhibiting compounds have been discovered and made available; however, even though some of these compounds underwent clinical trials, none have yet gone beyond Phase III trials...
June 7, 2017: Trends in Pharmacological Sciences
https://www.readbyqxmd.com/read/28600132/brentuximab-vedotin-or-physician-s-choice-in-cd30-positive-cutaneous-t-cell-lymphoma-alcanza-an-international-open-label-randomised-phase-3-multicentre-trial
#20
H Miles Prince, Youn H Kim, Steven M Horwitz, Reinhard Dummer, Julia Scarisbrick, Pietro Quaglino, Pier Luigi Zinzani, Pascal Wolter, Jose A Sanches, Pablo L Ortiz-Romero, Oleg E Akilov, Larisa Geskin, Judith Trotman, Kerry Taylor, Stephane Dalle, Michael Weichenthal, Jan Walewski, David Fisher, Brigitte Dréno, Rudolf Stadler, Tatyana Feldman, Timothy M Kuzel, Yinghui Wang, Maria Corinna Palanca-Wessels, Erin Zagadailov, William L Trepicchio, Wenwen Zhang, Hui-Min Lin, Yi Liu, Dirk Huebner, Meredith Little, Sean Whittaker, Madeleine Duvic
BACKGROUND: Cutaneous T-cell lymphomas are rare, generally incurable, and associated with reduced quality of life. Present systemic therapies rarely provide reliable and durable responses. We aimed to assess efficacy and safety of brentuximab vedotin versus conventional therapy for previously treated patients with CD30-positive cutaneous T-cell lymphomas. METHODS: In this international, open-label, randomised, phase 3, multicentre trial, we enrolled adult patients with CD30-positive mycosis fungoides or primary cutaneous anaplastic large-cell lymphoma who had been previously treated...
June 6, 2017: Lancet
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