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https://www.readbyqxmd.com/read/29452210/computer-simulations-for-bioequivalence-trials-selection-of-analyte-in-bcs-class-ii-and-iv-drugs-with-first-pass-metabolism-two-metabolic-pathways-and-intestinal-efflux-transporter
#1
V Mangas-Sanjuan, C Navarro-Fontestad, A García-Arieta, I F Trocóniz, M Bermejo
A semi-physiological two compartment pharmacokinetic model with two active metabolites (primary (PM) and secondary metabolites (SM)) with saturable and non-saturable pre-systemic efflux transporter, intestinal and hepatic metabolism has been developed. The aim of this work is to explore in several scenarios which analyte (parent drug or any of the metabolites) is the most sensitive to changes in drug product performance (i.e. differences in in vivo dissolution) and to make recommendations based on the simulations outcome...
February 13, 2018: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29451077/intravitreal-aflibercept-versus-ranibizumab-for-wet-age-related-macular-degeneration-a-cost-effectiveness-analysis
#2
Luis Hernandez, Tereza Lanitis, Clifford Cele, Hector Toro-Diaz, Andrea Gibson, Andreas Kuznik
BACKGROUND: Age-related macular degeneration (AMD) is the leading cause of vision loss in the United States. The most severe vision loss occurs in patients with neovascular AMD, known as wet AMD (wAMD). The most commonly used antivascular endothelial growth factor (VEGF) therapies approved by the FDA to treat patients with wAMD are ranibizumab, 0.5 mg administered by intravitreal injection once a month (approximately every 28 days), and intravitreal aflibercept injection (IAI), 2 mg every 4 weeks (monthly) for the first 12 weeks (3 months), followed by IAI 2 mg once every 8 weeks (2 months)...
February 16, 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29451036/pharmaceutical-grade-chondroitin-sulfate-in-the-management-of-knee-osteoarthritis
#3
Olivier Bruyère
Chondroitin Sulfate (CS) is a drug which is available as pharmaceutical-grade and nutriceutical-grade products, with important variations in preparation, composition, purity and therapeutic effects. Previous studies using pharmaceutical-grade CS suggested that the compound improves pain and function and delays structural progression in knee osteoarthritis (OA), whereas discrepant results were observed when lower grade preparations were investigated. The recently published chondroitin versus celecoxib versus Placebo Trial (CONCEPT) assessed the symptomatic effect of pharmaceutical-grade CS 800 mg/day in symptomatic knee OA...
February 16, 2018: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29450863/using-self-reported-patient-experiences-to-understand-patient-burden-learnings-from-digital-patient-communities-in-ankylosing-spondylitis
#4
Prashanth Sunkureddi, Dawn Gibson, Stephen Doogan, John Heid, Samir Benosman, Yujin Park
INTRODUCTION: Online communities contain a wealth of information containing unsolicited patient experiences that may go beyond what is captured by guided surveys or patient-reported outcome (PRO) instruments used in clinical settings. This study described patient experiences reported online to better understand the day-to-day disease burden of ankylosing spondylitis (AS). METHODS: Unguided, English-language patient narratives reported between January 2010 and May 2016 were collected from 52 online sources (e...
February 15, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29447382/randomized-controlled-trial-of-acupuncture-for-women-with-fibromyalgia-group-acupuncture-with-traditional-chinese-medicine-diagnosis-based-point-selection
#5
Scott D Mist, Kim Dupree Jones
Background: Group acupuncture is a growing and cost-effective method for delivering acupuncture in the United States and is the practice model in China. However, group acupuncture has not been tested in a research setting. Objective: To test the treatment effect of group acupuncture vs group education in persons with fibromyalgia. Design: Random allocation two-group study with repeated measures. Setting: Group clinic in an academic health center in Portland, Oregon...
February 13, 2018: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/29446874/transplant-recipients-are-vulnerable-under-the-medicare-part-d-benefit
#6
Lisa M Potter, Angela Q Maldonado, Krista L Lentine, Mark A Schnitzler, Zidong Zhang, Gregory P Hess, Edward Garrity, Bertram L Kasiske, David A Axelrod
Transplant immunosuppressants are often used off-label due to insufficient randomized prospective trial data to achieve organ-specific US Food and Drug Administration (FDA) approval. Transplant recipients who rely on Medicare Part D for immunosuppressant drug coverage are vulnerable to coverage denial for off-label prescriptions, unless use is supported by Centers for Medicare & Medicaid Services (CMS)-approved compendia. An integrated data set including national transplant registry data and 3 years of dispensed pharmacy records was used to identify the prevalence of immunosuppression use that is both off-label and not supported by CMS-approved compendia...
February 15, 2018: American Journal of Transplantation
https://www.readbyqxmd.com/read/29446851/non-commercial-versus-commercial-clinical-trials-a-retrospective-study-of-the-applications-submitted-to-a-research-ethics-committee
#7
Inmaculada Fuentes Camps, Alexis Rodríguez, Antonia Agustí
There are a lot of difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study some design characteristics, the clinical trial public register and the publication rate of non-commercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16...
February 15, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29446006/exploring-the-chemical-space-of-peptides-for-drug-discovery-a-focus-on-linear-and-cyclic-penta-peptides
#8
Bárbara I Díaz-Eufracio, Oscar Palomino-Hernández, Richard A Houghten, José L Medina-Franco
Peptide and peptide-like structures are regaining attention in drug discovery. Previous studies suggest that bioactive peptides have diverse structures and may have physicochemical properties attractive to become hit and lead compounds. However, chemoinformatic studies that characterize such diversity are limited. Herein, we report the physicochemical property profile and chemical space of four synthetic linear and cyclic combinatorial peptide libraries. As a case study, the analysis was focused on penta-peptides...
February 14, 2018: Molecular Diversity
https://www.readbyqxmd.com/read/29443664/nusinersen-versus-sham-control-in-later-onset-spinal-muscular-atrophy
#9
Eugenio Mercuri, Basil T Darras, Claudia A Chiriboga, John W Day, Craig Campbell, Anne M Connolly, Susan T Iannaccone, Janbernd Kirschner, Nancy L Kuntz, Kayoko Saito, Perry B Shieh, Már Tulinius, Elena S Mazzone, Jacqueline Montes, Kathie M Bishop, Qingqing Yang, Richard Foster, Sarah Gheuens, C Frank Bennett, Wildon Farwell, Eugene Schneider, Darryl C De Vivo, Richard S Finkel
BACKGROUND: Nusinersen is an antisense oligonucleotide drug that modulates pre-messenger RNA splicing of the survival motor neuron 2 ( SMN2) gene. It has been developed for the treatment of spinal muscular atrophy (SMA). METHODS: We conducted a multicenter, double-blind, sham-controlled, phase 3 trial of nusinersen in 126 children with SMA who had symptom onset after 6 months of age. The children were randomly assigned, in a 2:1 ratio, to undergo intrathecal administration of nusinersen at a dose of 12 mg (nusinersen group) or a sham procedure (control group) on days 1, 29, 85, and 274...
February 15, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29440464/outcome-measures-in-coeliac-disease-trials-the-tampere-recommendations
#10
Jonas F Ludvigsson, Carolina Ciacci, Peter Hr Green, Katri Kaukinen, Ilma R Korponay-Szabo, Kalle Kurppa, Joseph A Murray, Knut Erik Aslaksen Lundin, Markku J Maki, Alina Popp, Norelle R Reilly, Alfonso Rodriguez-Herrera, David S Sanders, Detlef Schuppan, Sarah Sleet, Juha Taavela, Kristin Voorhees, Marjorie M Walker, Daniel A Leffler
OBJECTIVE: A gluten-free diet is the only treatment option of coeliac disease, but recently an increasing number of trials have begun to explore alternative treatment strategies. We aimed to review the literature on coeliac disease therapeutic trials and issue recommendations for outcome measures. DESIGN: Based on a literature review of 10 062 references, we (17 researchers and 2 patient representatives from 10 countries) reviewed the use and suitability of both clinical and non-clinical outcome measures...
February 13, 2018: Gut
https://www.readbyqxmd.com/read/29438649/cannabis-for-paediatric-epilepsy-challenges-and-conundrums
#11
Kerrie-Anne Chen, Michelle A Farrar, Michael Cardamone, John A Lawson
Research is expanding for the use of cannabidiol as an anticonvulsant drug. The mechanism of cannabidiol in paediatric epilepsy is unclear but is thought to play a role in modulation of synaptic transmission. Evidence for its efficacy in treating epilepsy is limited but growing, with a single pharmaceutical company-funded randomised double-blind controlled trial in children with Dravet syndrome. Progress towards the use of medicinal cannabinoids incorporates a complex interplay of social influences and political and legal reform...
February 19, 2018: Medical Journal of Australia
https://www.readbyqxmd.com/read/29437768/fda-approval-ribociclib-for-the-treatment-of-postmenopausal-women-with-hormone-receptor-positive-her2-negative-advanced-or-metastatic-breast-cancer
#12
Anand Shah, Erik Bloomquist, Shenghui Tang, Wentao Fu, Youwei Bi, Qi Liu, Jingyu Yu, Ping Zhao, Todd R Palmby, Kirsten B Goldberg, C J George Chang, Paresma Patel, Elleni Alebachew, Amy Tilley, William F Pierce, Amna Ibrahim, Gideon M Blumenthal, Rajeshwari Sridhara, Julia A Beaver, Richard Pazdur
On March 13, 2017, the U.S. Food and Drug Administration approved ribociclib (KISQALI, Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. The approval was based on a randomized, double-blind, placebo-controlled, international clinical trial (MONALEESA-2)...
February 7, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29435938/transgene-like-animal-models-using-intronic-micrornas
#13
Shi-Lung Lin, Shin-Ju E Chang, Shao-Yao Ying
Transgenic animal models are valuable tools for testing gene functions and drug mechanisms in vivo. They are also the best similitude for a human body for etiological and pathological research of diseases. All pharmaceutically developed medicines must be proven to be safe and effective in animals before approval by the Food and Drug Administration (FDA) to be used in clinical trials. To this end, the transgenic animal models of diseases serve as the front line of drug evaluation. However, there is currently no transgenic animal model for microRNA (miRNA)-related research...
2018: Methods in Molecular Biology
https://www.readbyqxmd.com/read/29433740/foxos-maintaining-the-equilibrium-for-better-or-for-worse
#14
Sabina van Doeselaar, Boudewijn M T Burgering
A paradigm shift is emerging within the FOXO field and accumulating evidence indicates that we need to reappreciate the role of FOXOs, at least in cancer development. Here, we discuss the possibility that FOXOs are both tumor suppressors as well as promoters of tumor progression. This is mostly dependent on the biological context. Critical to this dichotomous role is the notion that FOXOs are central in preserving cellular homeostasis in redox control, genomic stability, and protein turnover. From this perspective, a paradoxical role in both suppressing and enhancing tumor progression can be reconciled...
2018: Current Topics in Developmental Biology
https://www.readbyqxmd.com/read/29432499/industry-corrupted-psychiatric-trials
#15
REVIEW
Jay D Amsterdam, Leemon B McHenry, Jon N Jureidini
The goal of this paper is to expose the research misconduct of pharmaceutical industry sponsored clinical trials via three short case studies of corrupted psychiatric trials that were conducted in the United States. We discuss the common elements that enable the misrepresentation of clinical trial results including ghostwriting for medical journals, the role of key opinion leaders as co-conspirators with the pharmaceutical industry and the complicity of top medical journals in failing to uphold standards of science and peer review...
December 30, 2017: Psychiatria Polska
https://www.readbyqxmd.com/read/29430415/impact-of-data-transparency-scientific-publications
#16
REVIEW
Mohit Joshi, Payal Bhardwaj
Data transparency has been an important aspect of medical research as it helps in enabling evidence-based decisions in medicine which leads to foster trust among the patients and research community alike. Currently, it is one of the key talking points owing to a number of initiatives taken by the pharmaceutical organizations, regulatory bodies, and the other decision enablers of the industry. Thanks to this, there are a number of ways by which a single piece of datum is available through multiple access points, namely, clinical trial disclosures (CTDs), clinical study reports (CSRs), plain language summaries, and scientific publications including abstracts, posters, and manuscripts, to name a few...
January 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/29426436/prospective-case-control-trial-evaluating-silicone-gel-for-the-treatment-of-direct-brow-lift-scars
#17
Nicolas Cadet, Isabelle Hardy, Diana Dudek, Krystyna Miszkiewicz, Patrick Boulos, Quyhn Nguyen, Jamie Wong
OBJECTIVE: To evaluate the effectiveness of a topical silicone gel on scars in patients who had undergone bilateral direct brow lift surgery. DESIGN: A randomized double-blind clinical trial with a placebo applied to one scar and topical silicone gel (Dermatix Ultra; Valeant Pharmaceuticals, Laval, Que.) used on the other scar for 2 months. PARTICIPANTS: Twelve patients (for a total of 24 surgical scars evaluated) were included in the study...
February 2018: Canadian Journal of Ophthalmology. Journal Canadien D'ophtalmologie
https://www.readbyqxmd.com/read/29425080/receptor-mediated-uptake-of-phosphorothioate-antisense-oligonucleotides-in-different-cell-types-of-the-liver
#18
Colton M Miller, Michael Tanowitz, Aaron J Donner, Thazha P Prakash, Eric E Swayze, Edward N Harris, Punit P Seth
Oligonucleotide therapeutics have emerged as a third distinct platform for drug discovery within the pharmaceutical industry. Five oligonucleotide-based drugs have been approved by the US FDA and over 100 oligonucleotides drugs are currently at different stages of human trials. Several of these oligonucleotide drugs are modified using the phosphorothioate (PS) backbone modification where one of the nonbridging oxygen atoms of the phosphodiester linkage is replaced with sulfur. In this review, we summarize our knowledge on receptor-mediated uptake of PS antisense oligonucleotides (ASOs) within different cell types of the liver-a privileged organ for the discovery of oligonucleotide-based therapeutics...
February 9, 2018: Nucleic Acid Therapeutics
https://www.readbyqxmd.com/read/29424255/the-therapeutic-potential-of-cetp-inhibitors-a-patent-review
#19
Xinran Wang, Wei Li, Lijuan Hao, Honglei Xie, Chenzhou Hao, Chunchi Liu, Wenyan Li, Xuqiong Xiong, Dongmei Zhao
Epidemiological studies have identified that high levels of low-density lipoprotein-cholesterol (LDL-C) and low levels of high-density lipoprotein-cholesterol (HDL-C) are two independent causes of cardiovascular disease (CVD). Statins, niacin and fibrate are used for the treatment of CVD. However, some defects are shown in the treatment process. Thus, there is a demand for better treatment strategies that confer preferable efficacy with fewer side effects. Cholesteryl ester transfer protein (CETP) promotes the movement of CEs from HDL to LDL and VLDL in exchange for triglycerides (TGs)...
February 9, 2018: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/29417755/safety-signal-detection-and-evaluation-in-clinical-development-programs-a-case-study-of-tofacitinib
#20
Gorana Dasic, Thomas Jones, Vera Frajzyngier, Ricardo Rojo, Ann Madsen, Hernan Valdez
Adverse events are anticipated during a clinical development program. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We describe here the process undertaken by Pfizer to investigate a safety signal for pancreatic cancer with tofacitinib. Potential cases of pancreatic cancer across indications from Pfizer's clinical trials and safety databases were identified and underwent in-depth case review and external expert consultation. The magnitude of the signal was quantified...
February 2018: Pharmacology Research & Perspectives
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