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Oral Anticoagulation in Atrial Fibrillation.
Authors: Ansari JG, Garcha GS, Lakkis N Abstract Atrial fibrillation affects approximately 5 million patients in the United States. The rate of stroke in adults with atrial fibrillation depending on their risk factors varies between 1-20% annually. Anticoagulation with vitamin K antagonists such as warfarin has been the mainstay therapy but it is cumbersome and requires close follow-up. Since 2010, three new oral anticoagulants have received Food and Drug Administration approval for stroke prevention in atrial fibrillation. This review summarizes data from three landmark trials: RE-LY, ROCKET-AF, and ARISTOTLE. In ...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - November 23, 2014 Category: Cardiology Tags: Cardiovasc Hematol Agents Med Chem Source Type: research

P2Y12 inhibitors: pharmacologic mechanism and clinical relevance.
Authors: Secco GG, Parisi R, Mirabella F, Fattori R, Genoni G, Agostoni P, De Luca G, Marino PN, Lupi A, Rognoni A Abstract Platelets play a critical role in the pathogenesis of atherothrombotic processes and inhibition of platelet aggregation by antiplatelet therapy is essential and really important in the acute coronary syndromes or in the setting of percutaneous coronary intervention. The first family of adenosine diphosphate P2Y12 receptors inhibiting drug is represented by thienopyridines and among these ticlopidine was the first approved by Food and Drug Administration; actually its use is discouraged because...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - November 23, 2014 Category: Cardiology Tags: Cardiovasc Hematol Agents Med Chem Source Type: research

Dabigatran: a new chapter in anticoagulation.
Authors: Ahmed S, Levin V, Malacoff R, Martinez MW Abstract For the last 60 years warfarin has been the cornerstone for chronic anticoagulation in prevention of ischemic strokes and systemic embolization. Warfarin therapy has several limitations including frequent monitoring and various food and significant drug interactions, which make it a less than ideal chronic oral anticoagulant. The continued search for safe, effective, medications with predictable pharmacokinetic profiles has led to newer alternatives. Dabigatran is a potent reversible, competitive direct thrombin inhibitor which is available as the prodrug,...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - November 23, 2014 Category: Cardiology Tags: Cardiovasc Hematol Agents Med Chem Source Type: research

Barrier Methods for Human Immunodeficiency Virus Prevention
Condoms remain the most effective barrier against the sexual transmission of the human immunodeficiency virus (HIV). Male condoms have proven to be 80% to 90% effective, and female condoms have similar results. Poor adherence and improper use limit their effectiveness. In addition to condoms, microbicides are a promising barrier against HIV transmission. More than 50 candidate topical microbicide compounds have undergone preclinical or clinical testing in the last 10 years, but there are currently no US Food and Drug Administration (FDA)-approved compounds. Rectal microbicides are also being developed, as anal receptive se...
Source: Infectious Diseases Clinics of North America - November 22, 2014 Category: Infectious Diseases Authors: Ellen F. Eaton, Craig J. Hoesley Source Type: research

The lingering question of menthol in cigarettes
Abstract Tobacco use is the single most important preventable cause of cancer-related deaths in the USA and many parts of the world. There is growing evidence that menthol cigarettes are starter tobacco products for children, adolescents, and young adults. Accumulating research also suggests that smoking menthol cigarettes reinforces nicotine dependence, impedes cessation, and promotes relapse. However, menthol cigarettes are exempt from the US Food and Drug Administration ban on flavored cigarettes due, in part, to the lack of empirical evidence describing the health consequences of smoking menthol cigarettes rel...
Source: Cancer Causes and Control - November 22, 2014 Category: Cancer & Oncology Source Type: research

Comparison of Image-guided Radiotherapy Technologies for Prostate Cancer
Radiation oncology has seen a rapid increase in the use of image-guided radiotherapy technology (IGRT) for prostate cancer patients over the past decade. The increase in the use of IGRT is largely driven by the fact that these technologies have been approved by the Food and Drug Administration and are now readily reimbursed by many insurance companies. Prostate cancer patients undergoing intensity modulated radiotherapy (IMRT) now have access to a wide variety of IGRTs that can cost anywhere from $500,000 or more in upfront costs, and can add anywhere from 10 to 15 thousand dollars to a course of IMRT. Some of the IGRT opt...
Source: American Journal of Clinical Oncology - November 21, 2014 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Purification and Mode of Action of Antilisterial Bacteriocins Produced by Lactobacillus pentosus SJ65 Isolated from Uttapam Batter
This study aims at partial purification of bacteriocins from Lactobacillus pentosus SJ65 isolated from fermented Uttapam batter, a South Indian fermented food source, their characterization and mode of action. The bacteriocin was purified using various strategies such as acetone precipitation, gel permeation and hydrophobic interaction chromatography. The bacteriocin was stable at acidic and neutral pH and up to 100C and exhibited a wide spectrum of activity against clinically relevant gram‐positive and gram‐negative pathogens. However, Tris‐tricine sodium dodecyl sulfate, native polyacrylamide gel electrophoresis ...
Source: Journal of Food Biochemistry - November 21, 2014 Category: Food Science Authors: Appukuttan Saraniya, Kadirvelu Jeevaratnam Tags: Full Article Source Type: research

An Electrical Cause of Stridor: Pediatric Vagal Nerve Stimulators
Vagal Nerve Stimulators (VNS) are surgically implantable medical devices which are approved by the Food and Drug administration (FDA) for treatment of medically refractory epilepsy in children. Two children with seizures disorders presented to the pediatric otolaryngology clinic with complaints of stridor and sleep apnea following implantation of VNS devices. Both children were evaluated with flexible laryngoscopy, direct laryngoscopy and bronchoscopy. The children were noted to have contraction of their vocal folds and supraglottis and the settings of their VNS were adjusted until no further contractions were noted. (Sour...
Source: International Journal of Pediatric Otorhinolaryngology - November 20, 2014 Category: ENT & OMF Authors: Gregory Kelts, Peter D. O’Connor, Richard W. Hussey, Stephen Maturo Tags: Case Report Source Type: research

James P. Allison received the 2014 Szent-Györgi Prize for Progress in Cancer Research.
This report highlights the history and mission of the Szent-Györgyi Prize, its role in promoting discovery-oriented cancer research, and the pioneering work led by the 2014 prize winner, Dr. James Allison. Dr. Allison's work in the area of cancer immunotherapy led to the successful development of immune checkpoint therapy, and the first drug approved by the United States Food and Drug Administration for the treatment of metastatic melanoma. PMID: 25189714 [PubMed - in process] (Source: Chinese Journal of Cancer)
Source: Chinese Journal of Cancer - November 19, 2014 Category: Cancer & Oncology Tags: Chin J Cancer Source Type: research

Assessing cognition and function in Alzheimer's disease clinical trials: Do we have the right tools?
Publication date: November 2014 Source:Alzheimer's & Dementia, Volume 10, Issue 6 Author(s): Peter J. Snyder , Kristin Kahle-Wrobleski , Stephen Brannan , David S. Miller , Rachel J. Schindler , Susan DeSanti , J. Michael Ryan , Glenn Morrison , Michael Grundman , Julie Chandler , Richard J. Caselli , Maria Isaac , Lisa Bain , Maria C. Carrillo Several lines of evidence from Alzheimer's disease (AD) research continue to support the notion that the biological changes associated with AD are occurring possibly several decades before an individual will experience the cognitive and functional changes associated with t...
Source: Alzheimer's and Dementia: The Journal of the Alzheimer's Association - November 19, 2014 Category: Geriatrics Source Type: research

Oseltamivir and zanamivir have limited effect on symptoms and do not reduce hospitalisation or serious complications of influenza
Commentary on: Jefferson T, Jones MA, Doshi P, et al.. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Cochrane Database Syst Rev 2014;4:CD008965. Context Neuraminidase inhibitors are widely prescribed for the treatment of influenza. Observational studies have reported that oseltamivir significantly lowers respiratory tract complications and the likelihood of hospitalisation, while an industry-sponsored systematic review of randomised controlled trials (RCTs) concluded that oseltamivir reduced the likelihood of complications requiring an antibiotic.1 2 However, many clinical t...
Source: Evidence-Based Medicine - November 19, 2014 Category: Internal Medicine Authors: Ebell, M. H. Tags: Clinical trials (epidemiology), Influenza, Pneumonia (infectious disease), Pneumonia (respiratory medicine), Ethics Therapeutics Source Type: research

Balancing competing risks: perinatal exposure to macrolides increases the risk of infantile hypertrophic pyloric stenosis
Commentary on: Lund M, Pasternak B, Davidsen RB, et al.. Use of macrolides in mother and child and risk of infantile hypertrophic pyloric stenosis: nationwide cohort study. BMJ 2014;348:g1908. Context Infantile hypertrophic pyloric stenosis (IHPS) is a potentially life-threatening condition for which surgical treatment yields excellent patient outcomes.1 However, the aetiology of IHPS remains elusive. Prior studies have implicated early neonatal exposure to erythromycin as a strong risk factor for IHPS, but it is less clear whether maternal use in late pregnancy or while breastfeeding also poses a risk.2 Perinatal exposure...
Source: Evidence-Based Medicine - November 19, 2014 Category: Internal Medicine Authors: Honein, M. A., Cragan, J. D. Tags: Epidemiologic studies, Stomach and duodenum, Childhood nutrition, Pregnancy Harm Source Type: research

Controversies concerning mitochondrial replacement therapy
Research on mitochondrial replacement therapy (MRT) holds the promise of helping women who have, or are at risk of transmitting, mitochondrial disease, but has recently been blocked by the Food and Drug Administration (FDA). Thus, several critical ethical and policy questions arise. Mitochondrial disease can be devastating for those who have it. Yet existing treatments remain supportive rather than curative. Women confronting this disease have a high chance of having an affected child and limited reproductive alternatives. (Source: Fertility and Sterility)
Source: Fertility and Sterility - November 19, 2014 Category: Reproduction Medicine Authors: Robert Klitzman, Mark Toynbee, Mark V. Sauer Tags: Conceptions Source Type: research

Likelihood approach for evaluating bioequivalence of highly variable drugs
Bioequivalence (BE) is required for approving a generic drug. The two one‐sided tests procedure (TOST, or the 90% confidence interval approach) has been used as the mainstream methodology to test average BE (ABE) on pharmacokinetic parameters such as the area under the blood concentration‐time curve and the peak concentration. However, for highly variable drugs (%CV > 30%), it is difficult to demonstrate ABE in a standard cross‐over study with the typical number of subjects using the TOST because of lack of power. Recently, the US Food and Drug Administration and the European Medicines Agency recommended similar b...
Source: Pharmaceutical Statistics - November 19, 2014 Category: Statistics Authors: Liping Du, Leena Choi Tags: Main Paper Source Type: research

Blend uniformity and powder phenomena inside the continuous tumble mixer using DEM simulations
This article is protected by copyright. All rights reserved. (Source: AIChE Journal)
Source: AIChE Journal - November 18, 2014 Category: Science Authors: Miguel Florian‐Algarin, Rafael Méndez Tags: Particle Technology and Fluidization Source Type: research

Preclinical pharmacology of amphetamine: Implications for the treatment of neuropsychiatric disorders
Publication date: September 2014 Source:Pharmacology & Therapeutics, Volume 143, Issue 3 Author(s): Peter H. Hutson , Frank I. Tarazi , Manisha Madhoo , Craig Slawecki , Ashwin A. Patkar The primary mechanism by which amphetamine exerts its neurobehavioral effects is through an enhancement of synaptic monoamine levels, which is mediated by interactions with monoamine transporters, storage, and metabolism. However, preclinical data are now emerging that support more widespread neurobiologic effects for amphetamine. This review describes preclinical evidence suggesting that direct interactions of amphetamine with m...
Source: Pharmacology and Therapeutics - November 18, 2014 Category: Drugs & Pharmacology Source Type: research

Mechanism of action of narcolepsy medications.
Abstract The medications used to treat narcolepsy are targeted toward alleviating symptoms such as excessive sleepiness and cataplexy. The cause of this neurological sleep disorder is still not completely clear, though a destruction of hypocretin/orexin neurons has been implicated. The destruction of these neurons is linked to inactivity of neurotransmitters including histamine, norepinephrine, acetylcholine, and serotonin, causing a disturbance in the sleep/wake cycles of narcoleptic patients. Stimulants and MAOIs have traditionally been used to counteract excessive daytime sleepiness and sleep attacks by inhibiti...
Source: CNS Spectrums - November 18, 2014 Category: Neurology Authors: Gowda CR, Lundt LP Tags: CNS Spectr Source Type: research

Cellular manufacturing for clinical applications.
Authors: Sheu J, Klassen H, Bauer G Abstract Rapid progress has been made in the development of novel cell-based approaches for the potential treatment of retinal degenerative diseases. As a result, one must consider carefully the conditions under which these therapeutics are manufactured if they are to be used in clinical studies or, ultimately, be approved as licensed cellular therapeutics. Here, we describe the principles behind the manufacturing of clinical-grade cellular products, as well as potential methods for large-scale expansion and processing according to Good Manufacturing Practice (GMP) standards sets...
Source: Developments in Ophthalmology - November 17, 2014 Category: Opthalmology Tags: Dev Ophthalmol Source Type: research

Drugs for Macular Degeneration
To the Editor In his Viewpoint, Dr Silver wrote that “After bevacizumab was introduced, the manufacturer, Genentech, received approval from the US Food and Drug Administration (FDA) for a genetically engineered variant of the Fab portion of bevacizumab to be used in small doses intraocularly to treat neovascular [age-related macular degeneration] AMD.” This is incorrect. (Source: JAMA)
Source: JAMA - November 17, 2014 Category: Journals (General) Source Type: research

Drug Derivation Clarified
In the Viewpoint entitled “Drugs for Macular Degeneration, Price Discrimination, and Medicare’s Responsibility Not to Overpay” published in the July 2, 2014, issue of JAMA (2014;312[1]:23-24. doi:10.1001/jama.2014.6672), the description of ranibizumab as the Fab portion of bevacizumab in the second paragraph was not accurate. The sentence should have read: “After bevacizumab was introduced, the manufacturer, Genentech, received approval from the US Food and Drug Administration (FDA) for a genetically engineered variant of the Fab portion of bevacizumab to be used in small doses intraocularly to treat neovascular AM...
Source: JAMA - November 17, 2014 Category: Journals (General) Source Type: research

Centralized adjudication of cardiovascular endpoints in cardiovascular and non-cardiovascular pharmacologic trials: A report from the cardiac safety research consortium
Publication date: Available online 10 November 2014 Source:American Heart Journal Author(s): Jonathan H. Seltzer , J. Rick Turner , Mary Jane Geiger , Giuseppe Rosano , Kenneth W. Mahaffey , William B. White , Mary Beth Sabol , Norman Stockbridge , Philip T. Sager This White Paper provides a summary of presentations and discussions at a Cardiovascular (CV) Endpoint Adjudication Think Tank co-sponsored by the Cardiac Safety Research Committee (CSRC) and the US Food and Drug Administration (FDA) that was convened at the FDA's White Oak headquarters on November 6th, 2013. Attention focused on the lack of clarity concerning ...
Source: American Heart Journal - November 17, 2014 Category: Cardiology Source Type: research

Comparison of The Roche Cobas® 4800 HPV assay to Digene Hybrid Capture 2, Roche Linear Array and Roche Amplicor for Detection of High-Risk Human Papillomavirus Genotypes in Women undergoing treatment for cervical dysplasia
The Roche Cobas 4800 HPV assay (Cobas) is currently accredited by Food and Drug Administration (FDA) for reflex testing of patients with atypical squamous cells of undetermined significance (ASC-US) cytology and in conjunction with routine Pap testing of women over age 30. This assay was also recently approved for use in primary screening of women over 25 years of age [1]. The clinical evaluation was primarily provided through a multicenter trial designed to demonstrate validation of the Cobas HPV test in these scenarios [2]. (Source: Journal of Clinical Virology)
Source: Journal of Clinical Virology - November 17, 2014 Category: Virology Authors: Samuel Phillips, Suzanne M. Garland, Jeffery H. Tan, Michael A. Quinn, Sepehr N. Tabrizi Tags: Short Communication Source Type: research

Comparison of the Roche Cobas 4800 HPV assay to Digene Hybrid Capture 2, Roche Linear Array and Roche Amplicor for Detection of High-Risk Human Papillomavirus Genotypes in Women undergoing treatment for cervical dysplasia
The Roche Cobas 4800 HPV assay (Cobas) is currently accredited by Food and Drug Administration (FDA) for reflex testing of patients with atypical squamous cells of undetermined significance (ASC-US) cytology and in conjunction with routine Pap testing of women over age 30. This assay was also recently approved for use in primary screening of women over 25 years of age [1]. The clinical evaluation was primarily provided through a multicenter trial designed to demonstrate validation of the Cobas HPV test in these scenarios [2]. (Source: Journal of Clinical Virology)
Source: Journal of Clinical Virology - November 17, 2014 Category: Virology Authors: Samuel Phillips, Suzanne M. Garland, Jeffery H. Tan, Michael A. Quinn, Sepehr N. Tabrizi Tags: Short Communication Source Type: research

Molecular action of lenalidomide in lymphocytes and hematologic malignancies.
Authors: McDaniel JM, Pinilla-Ibarz J, Epling-Burnette PK Abstract The immunomodulatory agent, lenalidomide, is a structural analogue of thalidomide approved by the US Food and Drug Administration for the treatment of myelodysplastic syndrome (MDS) and multiple myeloma (MM). This agent is also currently under active investigation for the treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL), as well as in drug combinations for some solid tumors and mantle cell lymphoma (MCL). Although treatment with lenalidomide has translated into a significant extension in overall survival in MM and MDS...
Source: Advances in Hematology - November 16, 2014 Category: Hematology Tags: Adv Hematol Source Type: research

Treatment of depression in a former smoker with varenicline? A case report and discussion.
Authors: Kausch O Abstract The U.S. Food and Drug Administration has warned that patients being treated for smoking cessation with varenicline may develop depression. A case of successful treatment for depression with varenicline is described. The patient's depression recurred several times with inadvertent varenicline discontinuation, then remitted again after resuming varenicline. The literature supporting the potential use of varenicline for depression is reviewed. PMID: 24763764 [PubMed - in process] (Source: Journal of Neuropsychiatry and Clinical Neurosciences)
Source: Journal of Neuropsychiatry and Clinical Neurosciences - November 16, 2014 Category: Psychiatry Tags: J Neuropsychiatry Clin Neurosci Source Type: research

Genotoxicity of styrene oligomers extracted from polystyrene intended for use in contact with food
Publication date: Available online 15 November 2014 Source:Toxicology Reports Author(s): Makoto Nakai , Mifumi Tsubokura , Masaru Suzuki , Saori Fujishima , Yoichi Watanabe , Yu Hasegawa , Kazuhiro Oyama , Shozo Ogura Here we conducted in vitro genotoxicity tests to evaluate the genotoxicity of styrene oligomers extracted from polystyrene intended for use in contact with food. Styrene oligomers were extracted with acetone and the extract was subjected to the Ames test (OECD test guideline No. 471) and the in vitro chromosomal aberration test (OECD test guideline No. 473) under good laboratory practice conditions. The con...
Source: Toxicology Reports - November 16, 2014 Category: Toxicology Source Type: research

Fluorescent nanoparticle imaging allows noninvasive evaluation of immune cell modulation in esophageal dysplasia.
Authors: Habibollahi P, Waldron T, Heidari P, Cho HS, Alcantara D, Josephson L, Wang TC, Rustgi AK, Mahmood U Abstract Esophageal tumors provide unique challenges and opportunities for developing and testing surveillance imaging technology for different tumor microenvironment components, including assessment of immune cell modulation, with the ultimate goal of promoting early detection and response evaluation. In this context, accessibility through the lumen using a minimally invasive approach provides a means for repetitive evaluation longitudinally by combining fluorescent endoscopic imaging technology with novel...
Source: Molecular Imaging - November 15, 2014 Category: Radiology Tags: Mol Imaging Source Type: research

Exploring the pharmacogenomics knowledge base (PharmGKB) for repositioning breast cancer drugs by leveraging Web ontology language (OWL) and cheminformatics approaches.
In this study, we used pharmacogenomics data generated from pharmacogenomics studies, applied informatics and Semantic Web technologies to address the drug repositioning problem. Specifically, we explored PharmGKB to identify pharmacogenomics related associations as pharmacogenomics profiles for US Food and Drug Administration (FDA) approved breast cancer drugs. We then converted and represented these profiles in Semantic Web notations, which support automated semantic inference. We successfully evaluated the performance and efficacy of the breast cancer drug pharmacogenomics profiles by case studies. Our results demonstra...
Source: Pacific Symposium on Biocomputing - November 15, 2014 Category: Bioinformatics Tags: Pac Symp Biocomput Source Type: research

Losartan administration reduces fibrosis but hinders functional recovery after volumetric muscle loss injury
This study shows that, after several weeks of recovery, VML injury results in little to no muscle regeneration, but is marked by persistent inflammation, chronic upregulation of profibrotic markers and extracellular matrix (i.e., collagen type I), and fat deposition at the defect site, which manifest irrecoverable deficits in force production. Losartan administration at 10 mg·kg–1·day–1 was able to modulate the gene expression of fibrotic markers and was also effective at reducing fibrosis (i.e., the deposition of collagen type I) in the injured muscle. However, there were no improvements in muscl...
Source: Journal of Applied Physiology - November 15, 2014 Category: Physiology Authors: Garg, K., Corona, B. T., Walters, T. J. Tags: ARTICLES Source Type: research

Beyond anti-VEGF: dual-targeting antiangiogenic and antiproliferative therapy.
Authors: Chen CT, Hung MC Abstract Antiangiogenesis is a promising antitumor strategy that inhibits tumor vascular formation to suppress tumor growth. Specifically, targeting VEGF has shown therapeutic benefits in many cancer types, leading to its approval as the first antiangiogenic drug by the Food and Drug Administration in the United States. It is known, however, that patients will experience unfavorable side effects as the VEGF and/or VEGF receptor signaling pathway is also required for homeostasis in normal tissues. Moreover, due to the cytostatic nature of antiangiogenic, cancer cells that are not killed by ...
Source: American Journal of Translational Research - November 14, 2014 Category: Research Tags: Am J Transl Res Source Type: research

Anticancer drug discovery from the marine environment.
Authors: Nastrucci C, Cesario A, Russo P Abstract Discovery, isolation, biochemical/pharmacological characterization, pre-clinical and clinical trials of drugs derived from the marine environment are continuously developing and increasing. One of the most promising area is cancer therapy. Currently, there are two drugs approved by the Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products (EMA) in cancer treatment, namely Cytarabine (Cytosar-U1®) and Eribulin (E7389 or Halaven®). Trabectedin (ET-743 or Yondelis1®), approved by EMA, is completing key Phase III studies in t...
Source: Recent Patents on Anti-Cancer Drug Discovery - November 14, 2014 Category: Cancer & Oncology Tags: Recent Pat Anticancer Drug Discov Source Type: research

Current and emerging nonsurgical treatment options for hidradenitis suppurativa.
Authors: Kerdel FA Abstract Several nonsurgical strategies for managing hidradenitis suppurativa (HS) are used that are successful in many patients. The overall goals of pharmacologic therapy are to clear or reduce the number and extent of current lesions and to prevent new lesions from forming. No pharmacologic agent is universally effective in all patients with HS, and, to date, none has been approved for this indication by the US Food and Drug Administration. Among the agents most commonly used are topical and systemic antibiotics and intralesional and systemic corticosteroids. Within the past decade, clinical e...
Source: Seminars in Cutaneous Medicine and Surgery - November 14, 2014 Category: Dermatology Tags: Semin Cutan Med Surg Source Type: research

Molecular platforms utilized to detect BRAF V600E mutation in melanoma.
Authors: Curry JL, Torres-Cabala CA, Tetzlaff MT, Bowman C, Prieto VG Abstract Metastatic melanoma (MM) is a deadly skin disease refractory to standard chemotherapy. Despite numerous clinical and pathological parameters derived to guide patient management, clinical outcomes in melanoma patients remain difficult to predict. There is a critical need to delineate the important biomarkers typical of this disease. These biomarkers will ideally illuminate those key biochemical pathways responsible for the aggressive behavior of melanoma and, in the process, unveil new opportunities for the design of rational therapeutic ...
Source: Seminars in Cutaneous Medicine and Surgery - November 14, 2014 Category: Dermatology Tags: Semin Cutan Med Surg Source Type: research

Phosphodiesterase type 5 inhibitor abuse: a critical review.
Authors: Lowe G, Costabile R Abstract Abuse of sildenafil has been reported since its introduction in 1999 and commonly documented in combination with illicit drugs among men and women of all ages. Increased risks of sexually transmissible diseases including HIV have been associated with sildenafil use in men who have sex with men. Recognizing the abuse potential of phosphodiesterase type 5 inhibitors (PDE5), we aim to summarize the current knowledge of this abuse. An investigation of EMBASE, PubMed, the Food and Drug Administration (FDA) website, MedWatch, and search engines was performed to evaluate information r...
Source: Current Drug Abuse Reviews - November 14, 2014 Category: Addiction Tags: Curr Drug Abuse Rev Source Type: research

Occurrence and diversity of Listeria spp. in seafood processing plant environments
This study aimed to gain a better understanding of the prevalence and diversity of Listeria spp., and to evaluate a rapid detection method, the 3M Molecular Detection Assay (MDA) Listeria, for its ability to detect Listeria spp. in environmental samples from seafood processing plants. Duplicate environmental sponge samples (n = 444) were collected from 152 different sites within three seafood processing plants, and analyzed for Listeria spp. by the MDA method (after 26 and 48 h of enrichment) and the U.S. Food and Drug Administration Bacteriological Analytical Manual method. Overall, detection of Listeria spp. by the tw...
Source: Food Control - November 14, 2014 Category: Food Science Source Type: research

Re: Joint Meeting for Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management Advisory Committee (DSARM AC), September 17, 2014
U.S. Food and Drug Administration (Source: The Journal of Urology)
Source: The Journal of Urology - November 14, 2014 Category: Urology & Nephrology Authors: Allen D. Seftel Tags: Urological Survey Source Type: research

Development of the Trevo ProVue Retriever for intracranial clot removal in acute ischemic stroke
It is estimated that 15 million people worldwide have a stroke each year. Of the estimated 795,000 strokes that occur in the United States annually, the majority are ischemic strokes resulting from an obstruction within a vessel supplying blood to the brain. The treatment goal for these patients is to restore blood flow as quickly as possible. Increasingly, endovascular treatments that interact directly with the clot are being pursued as options. Receiving U.S. Food and Drug Administration clearance in 2012, the Trevo® Retriever is a stent‐like structure to be deployed at the site of an occlusion to allow the occluding ...
Source: Annals of the New York Academy of Sciences - November 14, 2014 Category: Science Authors: Heather C. Prince, Amelia J. Saliba, Jaime Wheeler, Scott Bruder Tags: Original Article Source Type: research

Wireless capsule endoscopy: Perspectives beyond gastrointestinal bleeding.
Abstract Wireless capsule endoscopy (CE) is a technology developed for the endoscopic exploration of the small bowel. The first capsule model was approved by the Food and Drug Administration in 2001, and its first and essential indication was occult gastrointestinal (GI) bleeding. Over subsequent years, this technology has been refined to provide superior resolution, increased battery life, and capabilities to view different parts of the GI tract. Indeed, cases for which CE proved useful have increased significantly over the last few years, with new indications for the small bowel and technical improvements that ha...
Source: World Journal of Gastroenterology : WJG - November 14, 2014 Category: Gastroenterology Authors: Redondo-Cerezo E, Sánchez-Capilla AD, De La Torre-Rubio P, De Teresa J Tags: World J Gastroenterol Source Type: research

Expert consensus for postmarketing Chinese medicine intensive hospital safety monitoring
It is of vital significance to conduct active postmarketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China Food and Drug Administration. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The consensus has been developed by drawing on postmarketing safety monitoring of medicines and the advanced design concepts and methodologies from home and abroad, and complying with national laws, regulations and technical guidance documents, whilst taking into consideration the characteristics of CMs and the actua...
Source: European Journal of Integrative Medicine - November 13, 2014 Category: Complementary Medicine Authors: Yan-ming Xie, Xing Liao, Wen Zhang, Feng Tian, Yu-bin Zhao, Ming-quan Li, Yun-ling Zhang, Rong Ma, Shao-xiang Xian, Jian Liu, Su-yun Li, Ze-huai Wen, Zhong-qi Yang, Jian-dong Zou, Hong-sheng Sun, Yan He, Xue-lin Li, Jun-jie Jiang, Zhi-fei Wang, Yuan-yuan Tags: Abstracts GPTCM –RA and Speciality Committee of TCM Pharmaceutical analysis of WFCMS Source Type: research

Assessing temporal agreement between central and local progression‐free survival times
In oncology clinical trials, progression‐free survival (PFS), generally defined as the time from randomization until disease progression or death, has been a key endpoint to support licensing approval. In the U.S. Food and Drug Administration guidance for industry, May 2007, concerning the PFS as the primary or co‐primary clinical trial endpoint, it is recommended to have tumor assessments verified by an independent review committee blinded to study treatments, especially in open‐label studies. It is considered reassuring about the lack of reader‐evaluation bias if treatment effect estimates from the investigators'...
Source: Statistics in Medicine - November 13, 2014 Category: Statistics Authors: Donglin Zeng, Emil Cornea, Jun Dong, Jean Pan, Joseph G. Ibrahim Tags: Research Article Source Type: research

New and investigational antiretroviral drugs for HIV infection: mechanisms of action and early research findings.
This article summarizes a presentation by Michael S. Saag, MD, at the IAS-USA live Improving the Management of HCV Disease continuing medical education program held in New York in October 2012. PMID: 23363694 [PubMed - indexed for MEDLINE] (Source: Topics in antiviral medicine)
Source: Topics in antiviral medicine - November 12, 2014 Category: Infectious Diseases Tags: Top Antivir Med Source Type: research

Impact of Data Base Structure in a Successful In Vitro - In Vivo Correlation for Pharmaceutical Products
This article describes the implementation of a prototype object-oriented database (OODB) considered as a tool, which is helpful for decision taking, responding in a structured and consistent way to the issues of project management of IVIVC (including bioequivalence and bioavailability) (Food and Drug Administration 2003) necessary for the implementation of QTPP. (Source: The AAPS Journal)
Source: The AAPS Journal - November 12, 2014 Category: Drugs & Pharmacology Source Type: research

Is anti-D immunoglobulin still a frontline treatment option for immune thrombocytopenia?
Authors: Despotovic JM, Neunert CE Abstract A 5-year-old boy presents with platelet count of 2×10(9)/L and clinical and laboratory evidence of immune thrombocytopenia. He has epistaxis and oral mucosal bleeding. Complete blood count reveals isolated thrombocytopenia without any decline in hemoglobin and he is Rh+. You are asked if anti-D immunoglobulin is an appropriate initial therapy for this child given the 2010 Food and Drug Administration "black-box" warning. PMID: 24319192 [PubMed - in process] (Source: Hematology ASH Education Program)
Source: Hematology ASH Education Program - November 11, 2014 Category: Hematology Tags: Hematology Am Soc Hematol Educ Program Source Type: research

Phase 4 research: what happens when the rubber meets the road?
Authors: Crowther M Abstract Approval of a novel drug is oftentimes seen as the end of the development pathway. However, the appearance of rare but serious side effects in patients taking approved drugs has led to increased attention to phase 4, or postmarketing, research. Traditionally, postmarketing research relied on reports from clinicians to monitor for unexpected toxicity. However, such reporting will produce a biased assessment of risk due to underreporting of toxic effects in older medications. The availability of large, representative databases and more flexible analysis tools has led to comprehensive and ...
Source: Hematology ASH Education Program - November 11, 2014 Category: Hematology Tags: Hematology Am Soc Hematol Educ Program Source Type: research

Overview of the Food and Drug Administration Circulatory System Devices Panel Meetings on WATCHMAN™ Left Atrial Appendage Closure Therapy
The WATCHMAN (Boston Scientific Corp, Maple Grove, MN) left atrial appendage closure (LAAC) technology is a percutaneously delivered permanent cardiac implant placed in the LAA. This device is designed to reduce the risk of stroke and systemic embolism in warfarin-eligible patients with non-valvular atrial fibrillation. The first circulatory system device panel reviewed the Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF) study in 2009, and a “Not Approvable” letter was issued by the US Food and Drug Administration (FDA) based on safety concerns. (Source: The American Journal of Cardiology)
Source: The American Journal of Cardiology - November 11, 2014 Category: Cardiology Authors: Ron Waksman, Lakshmana K. Pendyala Source Type: research

Symptom dynamics during repeated serial allergen challenge chamber exposures to house dust mite
The proceedings of a National Institutes of Health workshop and a meeting of an Advisory Committee of the US Food and Drug Administration,1,2 as well as related commentaries,3,4 highlight the utility of an allergen challenge chamber (ACC) for conducting clinical trials for allergic rhinoconjunctivitis (AR). Mitigation of factors that might confound the design, analysis, and interpretation of these trials requires a systematic comparison of symptoms present in the natural setting versus those elicited after exposure to aeroallergens in an ACC. (Source: Journal of Allergy and Clinical Immunology)
Source: Journal of Allergy and Clinical Immunology - November 11, 2014 Category: Allergy & Immunology Authors: Robert L. Jacobs, Charles P. Andrews, Daniel A. Ramirez, Cynthia G. Rather, Nathan Harper, Fabio Jimenez, Hernan Martinez, Muthu Manoharan, Andrew Carrillo, Margit Gerardi, Robert E. Esch, Weijing He, Sunil K. Ahuja Tags: Letter to the Editor Source Type: research

Tanning lamps: Health effects and reclassification by the Food and Drug Administration
Tanning lamps have long been considered a class I medical device under regulation by the Food and Drug Administration (FDA). A growing body of research has repeatedly documented the association between elective indoor tanning and several negative health consequences. These accepted findings have prompted action by the FDA to officially reclassify tanning lamps as a class II medical device. The main purpose of this review is to update practitioners on the current state of tanning lamp classification and highlight the practical implications of this recent change. (Source: Journal of the American Academy of Dermatology)
Source: Journal of the American Academy of Dermatology - November 11, 2014 Category: Dermatology Authors: Alexander Ernst, Amanda Grimm, Henry W. Lim Tags: Review Source Type: research

Drug Development and Nonclinical to Clinical Translational Databases: Past and Current Efforts.
Abstract The International Consortium for Innovation and Quality (IQ) in Pharmaceutical Development is a science-focused organization of pharmaceutical and biotechnology companies. The mission of the Preclinical Safety Leadership Group (DruSafe) of the IQ is to advance science-based standards for nonclinical development of pharmaceutical products and to promote high-quality and effective nonclinical safety testing that can enable human risk assessment. DruSafe is creating an industry-wide database to determine the accuracy with which the interpretation of nonclinical safety assessments in animal models correctly pr...
Source: Toxicologic Pathology - November 10, 2014 Category: Pathology Authors: Monticello TM Tags: Toxicol Pathol Source Type: research

Medicalization of Marijuana
To the Editor In their Viewpoint, Drs Wilkinson and D’Souza expressed their opinion that cannabis should not be allowed for medical use. Their overarching argument was that cannabis has not been adequately studied or approved by the US Food and Drug Administration and is not administered like other drugs manufactured by pharmaceutical companies. We disagree with their claims about the investigations into the safety and efficacy of cannabis. (Source: JAMA)
Source: JAMA - November 8, 2014 Category: Journals (General) Source Type: research

Everolimus in liver transplantation
Purpose of review: In this review, we discuss the mechanism of action, side-effects, and role of everolimus (EVR) in liver transplant, specifically the most recent de-novo (within 1 month of transplant) and conversion (months to years after transplant) trials in the literature. Recent findings: Everolimus was recently approved by the Food and Drug Administration for use in liver transplantation. Its primary benefit over other immunosuppressive agents is the absence of renal toxicity. De-novo liver recipients receiving EVR with reduced-dose tacrolimus had similar rates of death, graft loss, and rejection compared with tacro...
Source: Current Opinion in Organ Transplantation - November 8, 2014 Category: Surgery Tags: IMMUNOSUPPRESSION: Edited by Linda S. Sher Source Type: research