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Carlijn C M Welten, Maarten W J Koeter, Tamar D Wohlfarth, Jitschak G Storosum, Wim van den Brink, Christine C Gispen-de Wied, Hubert G M Leufkens, Damiaan A J P Denys
OBJECTIVE: To investigate whether early nonresponse to antipsychotic treatment of acute mania predicts treatment failure and, if so, to establish the best definition or criterion of an early nonresponse. DATA SOURCES: Short-term efficacy studies assessing antipsychotics that were submitted to the Dutch Medicines Evaluation Board during an 11-year period as part of the marketing authorization application for the indication of acute manic episode of bipolar disorder...
September 2016: Journal of Clinical Psychiatry
Caijun Yang, Lina Wu, Wenfang Cai, Wenwen Zhu, Qian Shen, Zongjie Li, Yu Fang
OBJECTIVE: Drug shortages were a complex global problem. The aim of this study was to analyze, characterize, and assess the drug shortages, and identify possible solutions in Shaanxi Province, western China. METHODS: A qualitative methodological approach was conducted during May-June 2015 and December 2015-January 2016. Semi-structured interviews were performed to gather information from representatives of hospital pharmacists, wholesalers, pharmaceutical producers, and local health authorities...
2016: PloS One
Jan P Kamiński, Emily Miraflor, Karen Zaghiyan, Phillip Fleshner
Treatment of Crohn's disease (CD) relies on medical therapy with surgery reserved for medically refractory cases. This study measured pharmaceutical therapies that CD patients receive before surgery. Prospective data were collected on 558 patients undergoing surgery for medically refractory CD from November 1999 through June 2014. Patient demographics and preoperative medical therapies were tabulated, including types and number of doses of aminosalicylic acid, corticosteroids, immunomodulators, and biologic therapies...
October 2016: American Surgeon
Kevin D Clark, Cheng Zhang, Jared L Anderson
Biological and pharmaceutical samples represent formidable challenges in sample preparation that hold important consequences for bioanalysis and genotoxic impurity quantification. This Feature will emphasize significant advances toward the development of rapid, sensitive, and selective sample preparation methods.
October 25, 2016: Analytical Chemistry
Fumiaki Shima, Hirokazu Narita, Ayami Hiura, Hiroshi Shimoda, Mitsuru Akashi
There is considerable global demand for three-dimensional (3D) functional tissues which mimic our native organs and tissues for use as in vitro drug screening systems and in regenerative medicine. In particular, there has been an increasing number of patients who suffer from arterial diseases such as arteriosclerosis. As such, in vitro 3D arterial wall models that can evaluate the effects of novel medicines and a novel artificial graft for the treatment are required. In our previous study, we reported the rapid construction of 3D tissues by employing a Layer-by-Layer (LbL) technique and revealed their potential applications in the pharmaceutical fields and tissue engineering...
October 25, 2016: Journal of Biomedical Materials Research. Part A
Amanda C Capino, Jamie L Miller, Peter N Johnson
The need for sedation and analgesia and treatment of iatrogenic drug withdrawal is common in critically ill children. First-line therapy typically includes opioid agonists. However, clonidine, a central alpha2 agonist, has been suggested as a treatment option for sedation and analgesia and iatrogenic drug withdrawal. Therefore, we conducted a literature search to identify articles evaluating the use of enteral and transdermal clonidine in critically ill infants and children for sedation and analgesia and treatment of iatrogenic drug withdrawal...
October 25, 2016: Pharmacotherapy
Gianfranco Parati
Hypertension is associated with alterations in the vascular structure, which in turn enhance the risk of cardiovascular events. Notably, anti-hypertensive treatment may prevent or regress the changes of arterial wall structures. Lercanidipine is a third-generation CCB with peculiar pharmaceutical properties. Enalapril is an effective drug acting on the renin-angiotensin-aldosterone axis. This commentary discusses the vascular effects of the lercanidipine/enalapril combination, and comments on their potential clinical relevance...
October 2016: Current Medical Research and Opinion
Su Chen, Pengbo Zhang, Wanyun Shu, Yuzhen Gao, Guo Tang, Yufen Zhao
Pyrrolo[1,2-a]indole is a common structural motif found in many natural products and pharmaceuticals. A silver-mediated oxidative phosphinoylation of N-propargyl-substituted indoles was used to construct a variety of 2-phosphinoyl-9H-pyrrolo[1,2-a]indoles under mild conditions. This transformation offers a straightforward route to the formation of the C-P bond, cyclization, and isomerization in one step.
October 25, 2016: Organic Letters
Serli Önlü, Melek Türker Saçan
The authors constructed novel, robust and validated linear Quantitative Structure-Toxicity Relationship (QSTR) models in line with OECD criteria using the two cytotoxicity data sets which were obtained from the Alamar Blue (AB) and 5-carboxyfluorescein diacetate acetoxymethyl ester (CFDA-AM) assays. The data sets comprise the cytotoxic effect of structurally diverse and widely used pharmaceuticals, synthetic musks and industrial chemicals on the rainbow trout (Oncorhynchus mykiss) liver cell line RTL-W1. Common descriptors defined the relationship between structure and cytotoxicity for both the AB and the CFDA-AM assays which measure the metabolic activity and membrane integrity, respectively...
October 25, 2016: Environmental Toxicology and Chemistry
J L Baker, D Shriner, A R Bentley, C N Rotimi
As the common birthplace of all human populations, modern humans have lived longer on the African continent than in any other geographical region of the world. This long history, along with the evolutionary need to adapt to environmental challenges such as exposure to infectious agents, has led to greater genetic variation in Africans. The vast genetic variation in Africans also extends to genes involved in the absorption, distribution, metabolism and excretion of pharmaceuticals. Ongoing cataloging of these clinically relevant variants reveals huge allele-frequency differences within and between African populations...
October 25, 2016: Pharmacogenomics Journal
Eva C Thoma, Tobias Heckel, David Keller, Nicolas Giroud, Brian Leonard, Klaus Christensen, Adrian Roth, Cristina Bertinetti-Lapatki, Martin Graf, Christoph Patsch
Due to their broad differentiation potential, pluripotent stem cells (PSCs) offer a promising approach for generating relevant cellular models for various applications. While human PSC-based cellular models are already advanced, similar systems for non-human primates (NHPs) are still lacking. However, as NHPs are the most appropriate animals for evaluating the safety of many novel pharmaceuticals, the availability of in vitro systems would be extremely useful to bridge the gap between cellular and animal models...
October 25, 2016: Scientific Reports
Muhammad Ajaz Hussain, Muhammad Umer Ashraf, Gulzar Muhammad, Muhammad Nawaz Tahir, Syed Nasir Abbas Bukhari
The review summarizes the efforts to fabricate inclusion complexes of different therapeutic agents based on a versatile material . is a macrocyclic nano-basket which is the marvelous host with distinct hydrophobic three dimensional cavities to entrap and encapsulate biologically active guest drugs. and its derivatives are used as carriers (host-guest) for anti-cancer, anti-convulsant, anti-hypertensive, anthelmentic, anti-inflammatory, antimicrobial and anti-psychotic drugs, etc. They are the important biocompatible materials to improve solubility and chemical reactivity, and decrease cytotoxicity of poorly soluble drugs...
September 28, 2016: Current Pharmaceutical Design
Ygal Rotenstreich, Adi Tzameret, Sapir E Kalish, Ettel Bubis, Michael Belkin, Iris Moroz, Mordechai Rosner, Itay Levy, Shlomo Margel, Ifat Sher
PURPOSE: To investigate the feasibility and safety of a novel minimally invasive adjustable-depth blunt injector for pharmaceuticals delivery into the posterior segment. METHODS: Indocyanine green (ICG), sodium fluorescein and iron oxide nanoparticles (IONPs) were injected using the new injector into the extravascular spaces of the choroid (EVSC) compartment of rabbits and cadaver pig eyes. Spectral domain optical coherence tomography (SD-OCT), fundus imaging and histology analysis were performed for assessment of injection safety and efficacy...
October 25, 2016: Acta Ophthalmologica
M Viprey, R Jeannin, V Piriou, P Chevalier, C Michel, G Aulagner, J Berthiller, X Armoiry
WHAT IS KNOWN AND OBJECTIVE: The complex dose regimens of the direct-acting oral anticoagulants (DOAC) make their appropriate prescribing highly challenging. Inappropriate prescribing of the DOAC remains poorly addressed. We studied the patterns of DOAC prescription and estimated the prevalence of drug-related problems (DRPs) associated with their use. METHODS: A cross-sectional study was conducted using data from medical records system of the Lyon teaching hospitals...
October 24, 2016: Journal of Clinical Pharmacy and Therapeutics
Anthony J Hatswell, Nick Freemantle, Gianluca Baio
BACKGROUND: Pharmaceuticals are usually granted a marketing authorisation on the basis of randomised controlled trials (RCTs). Occasionally the efficacy of a treatment is assessed without a randomised comparator group (either active or placebo). OBJECTIVE: To identify and develop a taxonomic account of economic modelling approaches for pharmaceuticals licensed without RCT data. METHODS: We searched PubMed, the websites of UK health technology assessment bodies and the International Society for Pharmacoeconomics and Outcomes Research Scientific Presentations Database for assessments of treatments granted a marketing authorisation by the US Food and Drug Administration or European Medicines Agency from January 1999 to May 2014 without RCT data (74 indications)...
October 24, 2016: PharmacoEconomics
Aneta M Białkowska
2,3-Butanediol (2,3-BD) is a promising bulk chemical with a potentially wide range of applications e.g., in the manufacture of printing inks, perfumes, synthetic rubber, fumigants, antifreeze agents, fuel additives, foodstuffs and pharmaceuticals. Its high heating value and ability to increase the octane number of fuels make 2,3-BD a promising drop-in fuel. It can also be converted to methyl-ethyl ketone (MEK), which is considered an effective liquid fuel additive. After combination with MEK and hydrogenation reaction, 2,3-BD can be converted to octane, which is used to produce high-quality aviation fuel...
December 2016: World Journal of Microbiology & Biotechnology
Richard Bogan, Todd Swick, Mortimer Mamelak, Ruzica Kovacevic-Ristanovic, Chinglin Lai, Jed Black, Kathleen F Villa, Jacques Montplaisir
INTRODUCTION: The present post hoc analysis was designed to evaluate health-related quality of life (HRQoL) using the 36-item Short Form Health Status Survey (SF-36) during an 8-week trial of sodium oxybate (SXB). METHODS: SF-36 was assessed in a phase 3 placebo-controlled trial in patients with narcolepsy (N = 228) randomized to placebo or SXB in doses of 4.5, 6, or 9 g nightly for 8 weeks. Changes from baseline in SF-36 (last observation carried forward) were compared between SXB and placebo, and effect sizes (ES) were estimated...
October 24, 2016: Neurology and Therapy
Claudia Riedel, Birka Lehmann, Karl Broich, Thomas Sudhop
In Germany and throughout Europe, medicinal products for adults have been developed and evaluated systematically for decades. Medicinal products for children and adolescents, however, have only been researched for the past ten years. As a result, many medicinal products have been administered to children without systematic clinical trials, for example regarding dosage or pharmaceutical form.EU Regulation 1901/2006 aimes to close the gaps in the medical treatment of children and adolescents. In order to do so, the regulation provides for paediatric use marketing authorisations (PUMA) for previously authorised products no longer covered by intellectual property rights and also grants holders of such PUMA licenses further property rights...
October 24, 2016: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
Xuan Cao, Yu-Bei Lv, Jun Chen, Tadayuki Imanaka, Liu-Jing Wei, Qiang Hua
BACKGROUND: Limonene, a monocyclic monoterpene, is known for its using as an important precursor of many flavoring, pharmaceutical, and biodiesel products. Currently, d-limonene has been produced via fractionation from essential oils or as a byproduct of orange juice production, however, considering the increasing need for limonene and a certain amount of pesticides may exist in the limonene obtained from the citrus industry, some other methods should be explored to produce limonene. RESULTS: To construct the limonene synthetic pathway in Yarrowia lipolytica, two genes encoding neryl diphosphate synthase 1 (NDPS1) and limonene synthase (LS) were codon-optimized and heterologously expressed in Y...
2016: Biotechnology for Biofuels
Rieko Tanaka, Yuji Kumagai
Antibody drug is a kind of glycoprotein which molecular weight is over one hundred thousand. The number of pharmaceutical approval of antibody drug has been increasing in recent years. In terms of a working mechanism and pharmacokinetics, antibody drug is markedly different from existing low molecular weight drugs. In prospect, about body kinetics is the same. This paper describes general features of antibody drug mainly about internal kinetics in the first half. In the last half, body kinetics of human anti-RANKL monoclonal antibody called Denosumab and body kinetics changes in special population are outlined...
2016: Clinical Calcium
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