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Generic drug

Hui Liu, Fan Zhang, Shital Kumar Mishra, Shuigeng Zhou, Jie Zheng
Modeling of signaling pathways is crucial for understanding and predicting cellular responses to drug treatments. However, canonical signaling pathways curated from literature are seldom context-specific and thus can hardly predict cell type-specific response to external perturbations; purely data-driven methods also have drawbacks such as limited biological interpretability. Therefore, hybrid methods that can integrate prior knowledge and real data for network inference are highly desirable. In this paper, we propose a knowledge-guided fuzzy logic network model to infer signaling pathways by exploiting both prior knowledge and time-series data...
October 24, 2016: Scientific Reports
Adam C Fisher, Sau L Lee, Daniel P Harris, Lucinda Buhse, Steven Kozlowski, Lawrence Yu, Michael Kopcha, Janet Woodcock
Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality...
October 20, 2016: International Journal of Pharmaceutics
Julien Wils, Julie Favre, Jérémy Bellien
Diabetes induces a decrease in the number and function of different pro-angiogenic cells types generically designated as putative endothelial progenitor cells (EPC), which encompasses cells from myeloid origin that act in a paracrine fashion to promote angiogenesis and putative "true" EPC that contribute to endothelial replacement. This not only compromises neovasculogenesis in ischemic tissues but also impairs, at an early stage, the reendotheliziation process at sites of injury, contributing to the development of endothelial dysfunction and cardiovascular complications...
October 20, 2016: Pharmacology & Therapeutics
R Turck
Complaints about cancer drug costs are manifold. While there is excess in some cases and a significant financial burden for patients it appears that the outrage is not always well informed. In recent years innovative cancer drugs have improved patient' survival while better maintaining quality of life. Cancer drug costs represent less than 1% of overall healthcare costs, yet it is estimated that 83% of increased cancer survival can be attributed to new treatments. The challenge is to provide those cancer drugs that best address a patient's needs in the most cost-effective manner...
October 22, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Aaron S Kesselheim, Wesley Eddings, Tara Raj, Eric G Campbell, Jessica M Franklin, Kathryn M Ross, Lisa A Fulchino, Jerry Avorn, Joshua J Gagne
BACKGROUND: Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process...
2016: PloS One
Lawrence C Ku, Huali Wu, Rachel G Greenberg, Kevin D Hill, Daniel Gonzalez, Christoph P Hornik, Alysha Berezny, Jeffrey T Guptill, Wenlei Jiang, Nan Zheng, Michael Cohen-Wolkowiez, Chiara Melloni
BACKGROUND: Defining a drug's therapeutic index (TI) is important for patient safety and regulating the development of generic drugs. For many drugs, the TI is unknown. A systematic approach was developed to characterize the TI of a drug using therapeutic drug monitoring and electronic health record (EHR) data with pharmacokinetic (PK) modeling. This approach was first tested on phenytoin, which has a known TI, and then applied to lamotrigine, which lacks a defined TI. METHODS: Retrospective EHR data from patients in a tertiary hospital were used to develop phenytoin and lamotrigine population PK models and to identify adverse events (anemia, thrombocytopenia, and leukopenia) and efficacy outcomes (seizure-free)...
October 19, 2016: Therapeutic Drug Monitoring
Mingyue Zhao, Jing Wu
OBJECTIVE: Examine the effects of regulated competition on the drug pricing in China. METHODS: Based on product-level data, a regression method was employed for pricing by using data from Tianjin Urban Employee Basic Medical Insurance (UEBMI) database. The market competition measures distinguished generic competition within the same molecule from therapeutic competition within the same therapeutic class. RESULTS: The increases in pricing are inversely related to the number of generic competitions...
October 20, 2016: Expert Review of Pharmacoeconomics & Outcomes Research
William James Deardorff, George T Grossberg
Currently available therapies for the treatment of Alzheimer's disease (AD) consist of cholinesterase inhibitors (ChEIs), such as donepezil, and the N-methyl-D-aspartate receptor antagonist memantine. In December 2014, the US Food and Drug Administration approved Namzaric™, a once-daily, fixed-dose combination (FDC) of memantine extended-release (ER) and donepezil for patients with moderate-to-severe AD. The FDC capsule is bioequivalent to the coadministered individual drugs, and its bioavailability is similar when taken fasting, with food, or sprinkled onto applesauce...
2016: Drug Design, Development and Therapy
Joseph E Cruz, Zachariah Thomas, David Lee, David M Moskowitz, Jeff Nemeth
BACKGROUND: Generic price inflation has resulted in rising acquisition costs for sodium nitroprusside (SNP), an agent historically described as the drug of choice for the treatment of perioperative hypertension in cardiac surgery. PURPOSE: To describe the implementation and cost avoidance achieved by utilizing clevidipine as an alternative to SNP in cardiac surgery patients at a 520-bed community teaching hospital that performs more than 300 cardiac surgeries each year...
October 2016: P & T: a Peer-reviewed Journal for Formulary Management
Stephen Barlas
Generic companies press for REMS relief with Senate bill.
October 2016: P & T: a Peer-reviewed Journal for Formulary Management
Dwijen Kumar Choudhury, Babul Kumar Bezbaruah
OBJECTIVES: The aim of this study is to evaluate the prescribing pattern of analgesics and analyze the rational use of analgesic in orthopedic in-patient department of tertiary care teaching hospital, Guwahati, Assam. SUBJECTS AND METHODS: An observational and cross-sectional study was carried out for 1 month from April to May 2014. Collected data included age, sex, diagnosis and line of management during the study. The generic name and the average cost of treatment per patient were evaluated using Indian Drug Review, 2014...
July 2016: Indian Journal of Pharmacology
Sverre Kjeldsen
There is a whole armament of good drugs for treatment of hypertension including diuretics, calcium antagonist, angiotensin receptor antagonists and angiotensin converting enzyme inhibitors. Secondary drugs mostly used for special indications include beta-blockers, alpha-blockers, mineralocorticoid receptor antagonists (aldosterone antagonists), renin-inhibitors, centrally acting drugs, direct vasodilators and others.A variety of new drugs targeting different pressor mechanism exist and have partly been studies experimentally but will unlikely make it to clinical use in human hypertension...
September 2016: Journal of Hypertension
Albertino Damasceno
Hypertension is the main risk factor for morbidity and mortality in the world. In Sub-Saharan Africa, hypertension, previously almost unknown, is now a major risk factor. A paper recently published showed that mean systolic blood pressure is higher in all regions of Africa compared with other parts of the world, and, most important and contrary to what is happening in the rest of the world, it is increasing in the last years. Another important issue that characterises hypertension in Africa is its extremely low level of awareness and consequently low level of control...
September 2016: Journal of Hypertension
Agustin Ramirez
The presentation will focus on the different guidelines we have actually in hands (JNCHT 8, ESH / ESC, ISH) and compare them to the last Latin-American Society of Hypertension Guidelines to be published in this year.In this way, we will focus our attention in the socio-economic problem of the different countries in LA and the differences we have included in our Guidelines due to the actual needs in LA.Additionally we will specially mention the special populations from LA like andineans, people living over 500m from sea level, and the different black populations that are different from those described in North America...
September 2016: Journal of Hypertension
Mathew Clement, James A Pearson, Stephanie Gras, Hugo A van den Berg, Anya Lissina, Sian Llewellyn-Lacey, Mark D Willis, Tamsin Dockree, James E McLaren, Julia Ekeruche-Makinde, Emma Gostick, Neil P Robertson, Jamie Rossjohn, Scott R Burrows, David A Price, F Susan Wong, Mark Peakman, Ania Skowera, Linda Wooldridge
CD8(+) T-cells play a role in the pathogenesis of autoimmune diseases such as multiple sclerosis and type 1 diabetes. However, drugs that target the entire CD8(+) T-cell population are not desirable because the associated lack of specificity can lead to unwanted consequences, most notably an enhanced susceptibility to infection. Here, we show that autoreactive CD8(+) T-cells are highly dependent on CD8 for ligand-induced activation via the T-cell receptor (TCR). In contrast, pathogen-specific CD8(+) T-cells are relatively CD8-independent...
October 17, 2016: Scientific Reports
Bashir Mohamed Elmahi Yousif, Siripen Supakankunti
BACKGROUND: The appropriate use of medicines is essential for the provision of quality health services, patient safety, and the rational use of health resources. In Sudan, general practitioners (GPs) provide 80 % of insured patients' health services. Pharmaceutical service costs have been increasing since 2010. OBJECTIVES: We aimed to use the World Health Organization (WHO) and International Network for the Rational Use of Drugs prescribing indicators to assess prescription quality among GPs in different types of primary healthcare centers (PHCCs) within the National Health Insurance Fund (NHIF) in Gezira State, Sudan...
September 2016: Drugs—Real World Outcomes
Hong-Wei Fan, Zhi-Xiang Ma, Jing Chen, Xing-Ye Yang, Jun-Lin Cheng, Ying-Bin Li
INTRODUCTION: Hydroxychloroquine (HCQ), 4-aminoquinoline, is an antimalarial drug and has become a basic therapy for rheumatic disease treatment. It can stabilize the condition of SLE patients and reduce the chances of patient relapse through its immunosuppressive function and antiinflammatory effects. This drug was absorbed completely and rapidly by oral administration, but has a prolonged half-life for elimination. The objective of this study was to evaluate the pharmacokinetic parameters and relative bioequivalence of a new generic (test) formulation with the branded (reference) formulation of HCQ in healthy Chinese male volunteers...
December 2015: Rheumatol Ther
(no author information available yet)
Fosfomycin trometamol is a broad spectrum antibiotic recently marketed in the UK for the treatment of acute uncomplicated lower urinary tract infections (UTIs) in adults(1,2) and in adult and adolescent females.(3) It is also indicated for prophylaxis in diagnostic and surgical transurethral procedures.(1-3) Fosfomycin was discovered in 1969 and the reference drug was first marketed as Monuril in France in 1986.(3,4) Although Monuril had UK marketing authorisation, it was never distributed in the UK. However, national guidance included the option of using unlicensed imported fosfomycin...
October 2016: Drug and Therapeutics Bulletin
Aastha Gupta, Sandeep Juneja, Marco Vitoria, Vincent Habiyambere, Boniface Dongmo Nguimfack, Meg Doherty, Daniel Low-Beer
With anti-retroviral treatment (ART) scale-up set to continue over the next few years it is of key importance that manufacturers and planners in low- and middle-income countries (LMICs) hardest hit by the HIV/AIDS pandemic are able to anticipate and respond to future changes to treatment regimens, generics pipeline and demand, in order to secure continued access to all ARV medicines required. We did a forecast analysis, using secondary WHO and UNAIDS data sources, to estimate the number of people living with HIV (PLHIV) and the market share and demand for a range of new and existing ARV drugs in LMICs up to 2025...
2016: PloS One
Getahun E Agga, John W Schmidt, Terrance M Arthur
: Concerns have been raised that in-feed chlortetracycline (CTC) may increase antimicrobial resistance (AMR), specifically tetracycline-resistant (TET(r)) Escherichia coli, and third-generation cephalosporin-resistant (3GC(r)) E. coli We evaluated the impact of a 5-day in-feed CTC prophylaxis on animal health, TET(r) E. coli, and 3GC(r) E. coli A "control group" of cattle (n = 150) received no CTC, while a "CTC group" (n = 150) received in-feed CTC (10 mg/lb of body weight/day) from the 5th to the 9th day after feedlot arrival...
October 7, 2016: Applied and Environmental Microbiology
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