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https://www.readbyqxmd.com/read/28448887/macro-raman-spectroscopy-for-bulk-composition-and-homogeneity-analysis-of-multi-component-pharmaceutical-powders
#1
Hui Wang, David Barona, Sulayman Oladepo, Lisa Williams, Susan Hoe, David Lechuga-Ballesteros, Reinhard Vehring
A new macro-Raman system equipped with a motorized translational sample stage and low-frequency shift capabilities was developed for bulk composition and homogeneity analysis of multi-component pharmaceutical powders. Different sampling methods including single spot and scanning measurement were compared. It was found that increasing sample volumes significantly improved the precision of quantitative composition analysis, especially for poorly mixed powders. The multi-pass cavity of the macro-Raman system increased effective sample volumes by 20 times from the sample volume defined by the collection optics, i...
April 23, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28448782/amcp-partnership-forum-driving-value-and-outcomes-in-oncology
#2
(no author information available yet)
Innovation in cancer treatment has provided a wealth of recently available therapeutic agents and a healthy drug pipeline that promises to change the way we approach this disease and the lives of those affected in the years to come. However, the majority of these new agents, many of which are targeted to specific genomic features of various tumors, may challenge the health care system's ability to afford cancer care. This innovation drives the need to focus on the value of the treatments provided to patients with cancer and on methods to optimize the efficiency of the dollars we spend, in addition to the clinical value itself...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28445526/biosynthesis-of-the-oxygenated-diterpene-nezukol-in-the-medicinal-plant-isodon-rubescens-is-catalyzed-by-a-pair-of-diterpene-synthases
#3
Kyle A Pelot, David M Hagelthorn, J Bennett Addison, Philipp Zerbe
Plants produce an immense diversity of natural products (i.e. secondary or specialized metabolites) that offer a rich source of known and potentially new pharmaceuticals and other desirable bioproducts. The Traditional Chinese Medicinal plant Isodon rubescens (Lamiaceae) contains an array of bioactive labdane-related diterpenoid natural products. Of these, the ent-kauranoid oridonin is the most prominent specialized metabolite that has been extensively studied for its potent antimicrobial and anticancer efficacy...
2017: PloS One
https://www.readbyqxmd.com/read/28443099/a-century-of-radiation-therapy-and-adaptive-immunity
#4
REVIEW
Dörthe Schaue
The coming of age for immunotherapy (IT) as a genuine treatment option for cancer patients through the development of new and effective agents, in particular immune checkpoint inhibitors, has led to a huge renaissance of an old idea, namely to harness the power of the immune system to that of radiation therapy (RT). It is not an overstatement to say that the combination of RT with IT has provided a new conceptual platform that has re-energized the field of radiation oncology as a whole. One only has to look at the immense rise in sessions at professional conferences and in grant applications dealing with this topic to see its emergence as a force, while the number of published reviews on the topic is staggering...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28438231/health-technology-assessment-in-evaluation-of-pharmaceuticals-in-the-czech-republic
#5
Lenka Vostalová, Jana Mazelová, Jiří Samek, Milan Vocelka
OBJECTIVES: In the Czech Republic, the health technology assessment (HTA) approaches have been implemented in evaluation of medicinal products since 2008. The aim of this study was to provide an overview of the implementation of HTA and different levels thereof in the evaluation process conducted by the State Institute for Drug Control (SUKL) and to describe the impact of HTA on the entrance of new medicinal entities into out-patient healthcare system including highly innovative and orphan drugs...
April 25, 2017: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/28434919/a-review-of-dtca-techniques-appraising-their-success-and-potential-impact-on-medication-users
#6
REVIEW
Zaheer-Ud-Din Babar, Ashna Medina Siraj, Louise Curley
BACKGROUND: Direct-to-consumer advertising (DTCA) has been present in some countries for nearly two decades. Its success and ramifications have been examined but not yet cataloged recently in a comprehensive manner. OBJECTIVE: To review existing literature studies on the topic of DTCA techniques to provide an analysis of the current methods considered by drug marketers to enhance the effect of pharmaceutical product promotion and its success, as well as examine ramifications on the drug use process...
April 12, 2017: Research in Social & Administrative Pharmacy: RSAP
https://www.readbyqxmd.com/read/28428052/opening-eyes-to-nanomedicine-where-we-are-challenges-and-expectations-on-nanotherapy-for-diabetic-retinopathy
#7
REVIEW
Elisa J Campos, António Campos, João Martins, António Francisco Ambrósio
People affected with ocular diseases will significantly increase over the next decades, and, consequently, a substantial increase in health costs is expected. Diabetic retinopathy is the most common chronic complication of diabetes. The treatment of eye diseases affecting the posterior segment, such as diabetic retinopathy, is quite challenging due to the anatomy, physiology and biochemistry of the eye. Therefore, the development of new therapeutics for posterior eye diseases has been a major focus of pharmaceutical research in the area of vision sciences...
April 17, 2017: Nanomedicine: Nanotechnology, Biology, and Medicine
https://www.readbyqxmd.com/read/28425297/new-approaches-for-itaconic-acid-production-bottlenecks-and-possible-remedies
#8
Richa Bafana, R A Pandey
Currently, growing attention is being devoted to the conversion of biomass into value-added products, such as itaconic acid (IA), which is considered as the cleanest alternative to petroleum-based acrylic acid. IA is an unsaturated dicarboxylic acid that is used as a building block chemical for the production of several value-added products such as poly-itaconic acid. IA and its derivatives have a wide range of potential applications in textile, paint, pharmaceutical and chemical industries. Presently, industries are producing IA on the large scale by fermentation from glucose...
April 20, 2017: Critical Reviews in Biotechnology
https://www.readbyqxmd.com/read/28423954/the-design-and-scale-up-of-spray-dried-particle-delivery-systems
#9
Ali Al-Khattawi, Andrew Bayly, Andy Phillips, David Wilson
The rising demand for pharmaceutical particles with tailored physico-chemical properties has opened new markets for the spray drying technology especially for solubility enhancement, improvement of inhalation medicines and stabilization of biopharmaceuticals. Despite this, the literature on spray drying is scattered and often does not address the fundamental principles underpinning the robust development of pharmaceutical products. It is therefore necessary to present a clearer picture of the field and highlight the principles and factors influencing particle design and scale-up...
April 19, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28421428/how-has-cder-prepared-for-the-nano-revolution-a-review-of-risk-assessment-regulatory-research-and-guidance-activities
#10
Katherine M Tyner, Nan Zheng, Stephanie Choi, Xiaoming Xu, Peng Zou, Wenlei Jiang, Changning Guo, Celia N Cruz
The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial...
April 18, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28416645/performance-stability-of-silicon-oxide-coated-plastic-parenteral-vials
#11
Christopher M Weikart, Carlo G Pantano, Jeff R Schallenberger
A new packaging system was developed for parenteral pharmaceuticals that combines the best attributes of plastic and glass without their respective drawbacks. This technological advancement is based on the synergy between high precision injection-molded plastics and plasma coating technology. The result is a shatter resistant, optically clear, low particulate and chemically durable packaging system. The demand for this product is driven by the expanding market, regulatory constraints and product recalls for injectable drugs and biologics packaged in traditional glass materials...
April 17, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28416025/healthcare-innovation-and-patent-law-s-pharmaceutical-privilege-is-there-a-pharmaceutical-privilege-and-if-so-should-we-remove-it
#12
Graham Dutfield
This article reviews current trends in patent claims regarding personalised, stratified and precision medicine. These trends are not particularly well understood by policymakers, even less by the public, and are quite recent. Consequently, their implications for the public interest have hardly been thought out. Some see personalised and other secondary drug patent claims as promoting better targeted treatment. Others are inclined to see them as \manifestations of 'evergreening' whereby companies are, in some cases quite cynically, trying to extend market monopolies in old products or creating new monopolies based on supposedly improved versions of such earlier drugs...
April 18, 2017: Health Economics, Policy, and Law
https://www.readbyqxmd.com/read/28414846/clinical-trials-in-latin-america-implications-for-the-sustainability-and-safety-of-pharmaceutical-markets-and-the-wellbeing-of-research-subjects
#13
Núria Homedes, Antonio Ugalde
This study sought to verify whether drugs approved by the US Food and Drug Administration (FDA) were registered, commercialized and sold at affordable prices in the Latin American countries where they had been tested, as well as to ascertain their contribution to the quality of the pharmaceutical market. The list of New Molecular Entities (NMEs) approved by the FDA in 2011 and 2012 was consulted to determine the countries where pivotal trials were conducted. Affordability was assessed as a proportion of income and information on safety and efficacy was gathered from independent drug bulletins...
July 2016: Salud Colectiva
https://www.readbyqxmd.com/read/28410122/high-value-compounds-from-microalgae-with-industrial-exploitability-a-review
#14
Muhammad Bilal, Tahir Rasheed, Ishtiaq Ahmed, Hafiz M N Iqbal
  From the past several years, algal biotechnology has gained noticeable interests among research-based organizations and industrial sectors. Recent studies have provided considerable evidence that microalgae-derived bioactive compounds could play a vital role in bio- and non-bio sectors of the modern world. Microalgae-based industrial exploitability ranges from basic biomass-based food and feeds nutraceuticals to high-value pharmaceuticals, cosmeceuticals, ecological and biomedical applications. With ever increasing scientific knowledge, social and environmental awareness, bio-inspired synthesis of microalgae-based green products, and recent advancements in algal biotechnology will extend the utilization of microalgae into new areas...
June 1, 2017: Frontiers in Bioscience (Scholar Edition)
https://www.readbyqxmd.com/read/28409561/the-most-prevalent-side-effects-of-pegylated-liposomal-doxorubicin-monotherapy-in-women-with-metastatic-breast-cancer-a-systematic-review-of-clinical-trials
#15
REVIEW
L Ansari, F Shiehzadeh, Z Taherzadeh, S Nikoofal-Sahlabadi, A A Momtazi-Borojeni, A Sahebkar, S Eslami
Despite benefits of systemic chemotherapy in breast cancer treatment, several patients with early-stage breast cancer will develop metastatic breast cancer (MBC). Doxorubicin is among the most active agents against MBC. However, the use of doxorubicin is related to some life-threatening side effects including cardiotoxicity. Many efforts were made to lessen the side effects of doxorubicin and improve its efficacy. Pegylated liposomal doxorubicin (PLD) is a product claimed to achieve these two objectives because of its different pharmacokinetic profile...
April 14, 2017: Cancer Gene Therapy
https://www.readbyqxmd.com/read/28407936/optimization-of-the-recovery-of-high-value-compounds-from-pitaya-fruit-by-products-using-microwave-assisted-extraction
#16
Federico Ferreres, Clara Grosso, Angel Gil-Izquierdo, Patrícia Valentão, Ana T Mota, Paula B Andrade
A green microwave-assisted extraction of high value-added compounds from exotic fruits' peels was optimized by Box-Behnken design using 3 factors: solid/solvent ratio, X1, temperature, X2, and extraction time, X3. By using Derringer's desirability function, optimum extraction yields are obtained with X1=1/149.95g/mL, X2=72.27°C and X3=39.39min (white-fleshed red pitaya) and X1=1/148.96g/mL, X2=72.56°C and X3=5.02min (yellow pitaya) and a maximum betacyanin content is achieved with X1=1/150g/mL, X2=49.33°C and X3=5min...
September 1, 2017: Food Chemistry
https://www.readbyqxmd.com/read/28406289/phylogenomic-analysis-of-the-microviridin-biosynthetic-pathway-coupled-with-targeted-chemo-enzymatic-synthesis-yields-potent-protease-inhibitors
#17
Muhammad N Ahmed, Emmanuel Reyna-González, Bianca Schmid, Vincent Wiebach, Roderich D Süssmuth, Elke Dittmann, David P Fewer
Natural products and their semisynthetic derivatives are an important source of drugs for the pharmaceutical industry. Bacteria are prolific producers of natural products and encode a vast diversity of natural product biosynthetic gene clusters. However, much of this diversity is inaccessible to natural product discovery. Here, we use a combination of phylogenomic analysis of the microviridin biosynthetic pathway and chemo-enzymatic synthesis of bioinformatically predicted microviridins to yield new protease inhibitors...
April 26, 2017: ACS Chemical Biology
https://www.readbyqxmd.com/read/28400289/mathematical-modelling-of-liquid-transport-in-swelling-pharmaceutical-immediate-release-tablets
#18
Daniel Markl, Samy Yassin, D Ian Wilson, Daniel J Goodwin, Andrew Anderson, J Axel Zeitler
Oral dosage forms are an integral part of modern health care and account for the majority of drug delivery systems. Traditionally the analysis of the dissolution behaviour of a dosage form is used as the key parameter to assess the performance of a drug product. However, understanding the mechanisms of disintegration is of critical importance to improve the quality of drug delivery systems. The disintegration performance is primarily impacted by the hydration and subsequent swelling of the powder compact. Here we compare liquid ingress and swelling data obtained using terahertz pulsed imaging (TPI) to a set of mathematical models...
April 8, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28398242/drug-induced-liver-injury-can-biomarkers-assist-rucam-in-causality-assessment
#19
REVIEW
Rolf Teschke, Johannes Schulze, Axel Eickhoff, Gaby Danan
Drug induced liver injury (DILI) is a potentially serious adverse reaction in a few susceptible individuals under therapy by various drugs. Health care professionals facing DILI are confronted with a wealth of drug-unrelated liver diseases with high incidence and prevalence rates, which can confound the DILI diagnosis. Searching for alternative causes is a key element of RUCAM (Roussel Uclaf Causality Assessment Method) to assess rigorously causality in suspected DILI cases. Diagnostic biomarkers as blood tests would be a great help to clinicians, regulators, and pharmaceutical industry would be more comfortable if, in addition to RUCAM, causality of DILI can be confirmed...
April 11, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28396631/transcranial-electrical-stimulation-to-enhance-cognitive-performance-of-healthy-minors-a-complex-governance-challenge
#20
REVIEW
Jantien W Schuijer, Irja M de Jong, Frank Kupper, Nienke M van Atteveldt
An increasing number of healthy adolescents are consuming products that can enhance their cognitive performance in educational settings. Currently, the use of pharmaceuticals is the most widely discussed enhancement method in the literature, but new evidence suggests that other methods based on Transcranial Electrical Stimulation (tES) also have potential as cognitive enhancer. Just like pharmaceutical enhancers, the availability and education-related use of tES-devices raise a broad range of ethical, legal, and societal issues that need to be addressed by policy-makers...
2017: Frontiers in Human Neuroscience
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