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https://www.readbyqxmd.com/read/29229334/broad-range-chemical-profiling-of-natural-deep-eutectic-solvent-extracts-using-a-high-performance-thin-layer-chromatography-based-method
#1
Xiaojie Liu, Samantha Ahlgren, Henrie A A J Korthout, Luis F Salomé-Abarca, Lina M Bayona, Robert Verpoorte, Young Hae Choi
Natural deep eutectic solvents (NADES) made mainly with abundant primary metabolites are being increasingly applied in green chemistry. The advantages of NADES as green solvents have led to their use in novel green products for the food, cosmetics and pharma markets. However, one of the main difficulties encountered in the development of novel products and their quality control arises from their low vapour pressure and high viscosity. These features create the need for the development of new analytical methods suited to this type of sample...
December 6, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/29228145/rejuvenating-the-face-an-analysis-of-100-absorbable-suture-suspension-patients
#2
Michael Patrick Ogilvie, Julius Warren Few, Shikhar Singh Tomur, Chad Michael Teven, Alec James Semersky, Caroline Regan Bruno, Natasha Tamagni Kulick
Background: Absorbable suture suspension (Silhouette InstaLift, Sinclair Pharma, Irvine, CA) is a novel, minimally invasive system that utilizes a specially manufactured synthetic suture to help address the issues of facial aging, while minimizing the risks associated with historic thread lifting modalities. Objectives: The purpose of the study was to assess the safety, efficacy, and patient satisfaction of the absorbable suture suspension system in regards to facial rejuvenation and midface volume enhancement...
December 8, 2017: Aesthetic Surgery Journal
https://www.readbyqxmd.com/read/29226797/axicabtagene-ciloleucel-car-t-cell-therapy-in-refractory-large-b-cell-lymphoma
#3
Sattva S Neelapu, Frederick L Locke, Nancy L Bartlett, Lazaros J Lekakis, David B Miklos, Caron A Jacobson, Ira Braunschweig, Olalekan O Oluwole, Tanya Siddiqi, Yi Lin, John M Timmerman, Patrick J Stiff, Jonathan W Friedberg, Ian W Flinn, Andre Goy, Brian T Hill, Mitchell R Smith, Abhinav Deol, Umar Farooq, Peter McSweeney, Javier Munoz, Irit Avivi, Januario E Castro, Jason R Westin, Julio C Chavez, Armin Ghobadi, Krishna V Komanduri, Ronald Levy, Eric D Jacobsen, Thomas E Witzig, Patrick Reagan, Adrian Bot, John Rossi, Lynn Navale, Yizhou Jiang, Jeff Aycock, Meg Elias, David Chang, Jeff Wiezorek, William Y Go
Background In a phase 1 trial, axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, showed efficacy in patients with refractory large B-cell lymphoma after the failure of conventional therapy. Methods In this multicenter, phase 2 trial, we enrolled 111 patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, or transformed follicular lymphoma who had refractory disease despite undergoing recommended prior therapy. Patients received a target dose of 2×106 anti-CD19 CAR T cells per kilogram of body weight after receiving a conditioning regimen of low-dose cyclophosphamide and fludarabine...
December 10, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29222625/using-patient-feedback-to-optimize-the-design-of-a-certolizumab-pegol-electromechanical-self-injection-device-insights-from-human-factors-studies
#4
Barbara Domańska, Oliver Stumpp, Steven Poon, Serkan Oray, Irina Mountian, Clovis Pichon
INTRODUCTION: We incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of ava®, an electromechanical device (e-Device) for self-injecting the anti-tumor necrosis factor certolizumab pegol (CZP). METHODS: Healthcare professionals, caregivers, healthy volunteers, and patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn's disease participated in 11 formative HFS to optimize the e-Device design through intended user feedback; nine studies involved simulated injections...
December 8, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/29218492/efficacy-of-secukinumab-in-the-treatment-of-moderate-to-severe-plaque-psoriasis-in-the-north-american-subgroup-of-patients-pooled-analysis-of-four-phase-3-studies
#5
David Pariser, Ellen Frankel, Joel Schlessinger, Yves Poulin, Ronald Vender, Richard G Langley, Xiangyi Meng, Adriana Guana, Judit Nyirady
INTRODUCTION: Demographic and disease characteristics may impact response to psoriasis therapies. The objective of this study is to explore the safety and efficacy profile of secukinumab in North American (NA) versus non-NA patients with moderate to severe psoriasis. METHODS: Data were pooled from four phase 3 studies of secukinumab. Secukinumab (300 and 150 mg) was administered at baseline, weeks 1, 2, and 3, then every 4 weeks from week 4 to 48. RESULTS: Peak efficacy was observed at week 16 in NA and non-NA patients with secukinumab 300 mg and secukinumab 150 mg, and disease clearance was maintained to week 52...
December 7, 2017: Dermatology and Therapy
https://www.readbyqxmd.com/read/29217520/alex-azar-critics-cry-revolving-door-as-trump-picks-pharma-executive-for-top-us-health-job
#6
Liz Seegert
No abstract text is available yet for this article.
December 7, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/29216926/pro-inflammatory-adjuvant-properties-of-pigment-grade-titanium-dioxide-particles-are-augmented-by-a-genotype-that-potentiates-interleukin-1%C3%AE-processing
#7
Sebastian Riedle, Laetitia C Pele, Don E Otter, Rachel E Hewitt, Harjinder Singh, Nicole C Roy, Jonathan J Powell
BACKGROUND: Pigment-grade titanium dioxide (TiO2) particles are an additive to some foods (E171 on ingredients lists), toothpastes, and pharma-/nutraceuticals and are absorbed, to some extent, in the human intestinal tract. TiO2 can act as a modest adjuvant in the secretion of the pro-inflammatory cytokine interleukin 1β (IL-1β) when triggered by common intestinal bacterial fragments, such as lipopolysaccharide (LPS) and/or peptidoglycan. Given the variance in human genotypes, which includes variance in genes related to IL-1β secretion, we investigated whether TiO2 particles might, in fact, be more potent pro-inflammatory adjuvants in cells that are genetically susceptible to IL-1β-related inflammation...
December 8, 2017: Particle and Fibre Toxicology
https://www.readbyqxmd.com/read/29213040/-brivaracetam-in-the-treatment-of-patients-with-epilepsy
#8
V A Karlov, P N Vlasov, I A Zhidkova, M Ya Kissin, A V Lebedeva, L V Lipatova, V R Mkrtchyan, K Yu Mukhin, I G Rudakova
The newest antiepileptic drug (AED) brivaracetam (Briviac, UCB Pharma) (BRV) was approved in the Russian Federation in 2017 as an adjuvant therapy for the treatment of partial seizures with/without secondary generalization in adults and adolescents over 16 years old with epilepsy. This review contains the data of BRV preclinical studies, pharmacokinetic profile and the results of comparative study of BRV and LEV. The results of main studies of efficacy and tolerability with pooled analysis as well as data from meta-analysis are presented...
2017: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
https://www.readbyqxmd.com/read/29209955/acalabrutinib-first-global-approval
#9
Anthony Markham, Sohita Dhillon
Acerta Pharma is developing the Bruton's tyrosine kinase inhibitor acalabrutinib (Calquence®) for the treatment of various haematological and solid malignancies. The drug has received accelerated approval from the US FDA for the treatment of mantle cell lymphoma based on the results of a phase II study, and phase III trials in mantle cell lymphoma and chronic lymphocytic leukaemia are currently underway. This article summarizes the milestones in the development of acalabrutinib leading to this first approval for mantle cell lymphoma...
December 5, 2017: Drugs
https://www.readbyqxmd.com/read/29209131/dramatic-response-of-hepatitis-c-patients-chronically-infected-with-hepatitis-c-virus-genotype-3-to-sofosbuvir-based-therapies-in-punjab-pakistan-a-prospective-study
#10
Sajjad Iqbal, Muhammad Haroon Yousuf, Muhammad Iftikhar Yousaf
AIM: To prospectively evaluate the efficacy of sofobuvir (SOF) in hepatitis C patients infected with hepatitis C virus (HCV) genotype 3 in Pakistan. METHODS: The present study was performed with the coordination of gastroenterology and pathology departments of Shalamar Hospital Lahore from August 2014 to May 2016. The total number of patients included in this study was 1375 and all of them were infected with HCV genotype 3. On the basis of drug combinations, all the patients were separated into two groups...
November 28, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/29197875/efficacy-and-tolerability-of-leuprorelin-acetate-eligard%C3%A2-in-daily-practice-in-germany-pooled-data-from-2-prospective-non-interventional-studies-with-3-or-6-month-depot-formulations-in-patients-with-advanced-prostate-cancer
#11
Carsten-Henning Ohlmann, Marco Gross-Langenhoff
INTRODUCTION: We evaluated the efficacy and tolerability of 3- and 6-month leuprorelin acetate (LA) depot formulations (Eligard®, Astellas Pharma GmbH) in patients with advanced prostate cancer treated in routine clinical practice in Germany. MATERIALS AND METHODS: Data was pooled from 2 prospective, open-label, non-interventional studies in which 1,906 patients were treated for 12 months with either the 3-month (n = 633) or 6-month (n = 1,273) LA formulation...
December 1, 2017: Urologia Internationalis
https://www.readbyqxmd.com/read/29181493/neflamapimod-clinical-phase-2b-ready-oral-small-molecule-inhibitor-of-p38%C3%AE-to-reverse-synaptic-dysfunction-in-early-alzheimer-s-disease
#12
J Alam, K Blackburn, D Patrick
Neflamapimod (previously code named VX-745) is a clinical phase 2b-ready highly specific inhibitor of the intra-cellular enzyme p38 mitogen activated protein kinase alpha ("p38α") that is being developed as a disease-modifying drug for Alzheimer's disease (AD) that acts via targeting synaptic dysfunction. Neflamapimod was discovered through a proprietary structure-based drug discovery platform at Vertex Pharmaceuticals, and developed previously by Vertex through to phase 2a in rheumatoid arthritis. EIP Pharma licensed the compound in 2014 for development and commercialization as a treatment of central nervous system (CNS) disorders...
2017: Journal of Prevention of Alzheimer's Disease
https://www.readbyqxmd.com/read/29180728/cryo-electron-microscopy-makes-waves-in-pharma-labs
#13
Mark Peplow
No abstract text is available yet for this article.
November 28, 2017: Nature Reviews. Drug Discovery
https://www.readbyqxmd.com/read/29177699/a-phase-ic-study-evaluating-the-safety-tolerability-pharmacokinetics-and-cognitive-outcomes-of-bi-409306-in-patients-with-mild-to-moderate-schizophrenia
#14
David Brown, Kristen Daniels, Solen Pichereau, Michael Sand
INTRODUCTION: This randomized, double-blind, parallel-group study investigated the safety, tolerability, pharmacokinetics (PK), and cognitive outcomes of BI 409306-a selective phosphodiesterase 9A (PDE9A) inhibitor-in patients with schizophrenia. METHODS: Patients with mild-to-moderate schizophrenia were randomized (1:1:1:1) to receive BI 409306 at 25, 50, or 100 mg or placebo once daily over 14 days. The primary endpoints were safety and tolerability; the secondary endpoints were PK and cognitive outcomes...
November 24, 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/29175699/-do-it-yourself-vaccine-rejection-and-complementary-and-alternative-medicine-cam
#15
Katie Attwell, Paul R Ward, Samantha B Meyer, Philippa J Rokkas, Julie Leask
In this article, we elucidate a symbiotic relationship between complementary and alternative medicine (CAM) and rejection of, or hesitancy towards, vaccination. In Fremantle, Western Australia, and Adelaide, South Australia, we conducted in-depth interviews from September 2013-December 2015 with 29 parents who had refused or delayed some or all of their children's vaccines. Our qualitative analysis found that for many, their do-it-yourself ethic and personal agency was enhanced by self-directed CAM use, alongside (sometimes informal) CAM practitioner instruction...
November 16, 2017: Social Science & Medicine
https://www.readbyqxmd.com/read/29174115/modeling-clinical-efficacy-of-the-s1p-receptor-modulator-ponesimod-in-psoriasis
#16
Andreas Krause, Daniele D'Ambrosio, Jasper Dingemanse
BACKGROUND: Ponesimod is currently the only S1P receptor modulator studied in psoriasis. In a dose-finding study, the active doses showed similar efficacy. OBJECTIVE: Prediction of efficacy at lower doses to aid clinical phase 3 planning with respect to dose selection, duration of treatment, and patient inclusion criteria based on pharma-co-kinetic/pharmacodynamic (PK/PD) modeling and simulation. METHODS: The dose-finding study treated 326 patients (67 on placebo, 126 on 20mg, and 133 on 40mg) over 16 weeks...
November 20, 2017: Journal of Dermatological Science
https://www.readbyqxmd.com/read/29164480/dispensing-patterns-of-ranibizumab-and-aflibercept-for-the-treatment-of-neovascular-age-related-macular-degeneration-a-retrospective-cohort-study-in-australia
#17
Adrian Skelly, Hans-Joachim Carius, Vladimir Bezlyak, Fred K Chen
INTRODUCTION: Anti-vascular endothelial growth factor therapy is the standard of care for neovascular age-related macular degeneration (nAMD). The dosage of two licensed agents, ranibizumab and aflibercept, was established through clinical trials; however, it is unclear if either agent is administered as recommended in routine clinical practice. Using pharmacy claims data, we investigated if the dispensing patterns of ranibizumab differ from those of aflibercept 6 and 12 months after treatment initiation...
November 21, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/29162334/results-of-asertaa-a-randomized-prospective-crossover-pharmacogenetic-study-of-immediate-release-versus-extended-release-tacrolimus-in-african-american-kidney-transplant-recipients
#18
Jennifer Trofe-Clark, Daniel C Brennan, Patricia West-Thielke, Michael C Milone, Mary Ann Lim, Robin Neubauer, Vincenza Nigro, Roy D Bloom
BACKGROUND: Differences in tacrolimus dosing across ancestries is partly attributable to polymorphisms in CYP3A5 genes that encode tacrolimus-metabolizing cytochrome P450 3A5 enzymes. The CYP3A5*1 allele, preponderant in African Americans, is associated with rapid metabolism, subtherapeutic concentrations, and higher dose requirements for tacrolimus, all contributing to worse outcomes. Little is known about the relationship between CYP3A5 genotype and the tacrolimus pharmacokinetic area under the curve (AUC) profile in African Americans or whether pharmacogenetic differences exist between conventional twice-daily, rapidly absorbed, immediate-release tacrolimus (IR-Tac) and once-daily extended-release tacrolimus (LifeCycle Pharma Tac [LCPT]) with a delayed absorption profile...
November 18, 2017: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
https://www.readbyqxmd.com/read/29141717/diagnostic-accuracy-of-global-pharma-health-fund-minilab%C3%A2-in-assessing-pharmacopoeial-quality-of-antimicrobials
#19
Hui Pan, William Ba-Thein
Global Pharma Health Fund (GPHF) Minilab™, a semi-quantitative thin-layer chromatography (TLC)-based commercially available test kit, is widely used in drug quality surveillance globally, but its diagnostic accuracy is unclear. We investigated the diagnostic accuracy of minilab system for antimicrobials, using high-performance liquid chromatography (HPLC) as reference standard. Following the Minilab protocols and the Pharmacopoeia of the People's Republic of China protocols, Minilab-TLC and HPLC were used to test five common antimicrobials (506 batches) for relative concentration of active pharmaceutical ingredients...
November 6, 2017: American Journal of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/29138986/secukinumab-in-active-rheumatoid-arthritis-after-anti-tnf%C3%AE-therapy-a-randomized-double-blind-placebo-controlled-phase-3-study
#20
Hasan Tahir, Atul Deodhar, Mark Genovese, Tsutomu Takeuchi, Jacob Aelion, Filip Van den Bosch, Sibylle Haemmerle, Hanno B Richards
INTRODUCTION: 'REASSURE' (NCT01377012), a phase 3 study, evaluated the efficacy and safety of secukinumab in patients with active rheumatoid arthritis (RA) who had an inadequate response to, or intolerance of, tumor necrosis factor inhibitors (TNF-inhibitors). METHODS: A total of 637 patients were randomized (1:1:1) to receive intravenous secukinumab 10 mg/kg (baseline, weeks 2 and 4) followed by subcutaneous secukinumab 150 mg or 75 mg every 4 weeks (starting from week 8) or placebo at the same dosing schedule...
December 2017: Rheumatology and Therapy
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