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PubMed Journals Articles About "Sunovion Announces Acceptance Review Drug Application Dasotraline Treatment" RSS

08:15 EST 14th November 2018 | BioPortfolio

Sunovion Announces Acceptance Review Drug Application Dasotraline Treatment PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Sunovion Announces Acceptance Review Drug Application Dasotraline Treatment articles that have been published worldwide.

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Showing "Sunovion Announces Acceptance Review Drug Application Dasotraline Treatment" PubMed Articles 1–25 of 53,000+

Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices. Final rule.

The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a huma...


Improving sensory acceptance and physicochemical properties by ultrasound application to restructured cooked ham with salt (NaCl) reduction.

The objective of this research was to study the effects of salt reduction and the application of ultrasound (nominal current of 600 W cm for 10 min) on the physicochemical properties, the microstructure and the sensory acceptance of restructured cooked ham. Four treatments with reduced salt including one with the application of ultrasound (1.5, 1.12, 0.75 and 0.75% salt + ultrasound) were produced. The treatment with 0.75% salt provided a reduction of about 30% in the sodium content. The use of ultras...

Relationship Between the Review Time and Various PMDA Consultations in Recent New Drug Approval Cases in Japan.

It is considered important that the applicants and reviewers communicate well from the development stage and that both mutually understand the development strategy and application contents in conducting the review efficiently after the application is submitted. Therefore, we focus on Pharmaceuticals and Medical Devices Agency (PMDA) consultations from the viewpoint of communication before the application and clarify the issues to consider in the challenge to reduce the review time in terms of the relationsh...


Polymer-drug conjugates in inflammation treatment.

Inflammation is a vital defense mechanism of living organisms. However, persistent and chronic inflammation may lead to severe pathological processes and evolve into various chronic inflammatory diseases (CID), e.g. rheumatoid arthritis, multiple sclerosis, multiple sclerosis, systemic lupus erythematosus or inflammatory bowel diseases, or certain types of cancer. Their current treatment usually does not lead to complete remission. The application of nanotherapeutics may significantly improve CID treatment,...

Therapeutic Drug Monitoring of Antiepileptic Drugs in Epilepsy: A 2018 Update.

Antiepileptic drugs (AEDs) are the mainstay of epilepsy treatment. Since 1989, 18 new AEDs have been licensed for clinical use and there are now 27 licensed AEDs in total for the treatment of patients with epilepsy. Furthermore, several AEDs are also used for the management of other medical conditions, e.g., pain and bipolar disorder. This has led to an increasingly widespread application of therapeutic drug monitoring (TDM) of AEDs, making AEDs among the most common medications for which TDM is performed. ...

Consumer acceptance of cultured meat: A systematic review.

Cultured meat grown in-vitro from animal cells is being developed as a way of addressing many of the ethical and environmental concerns associated with conventional meat production. As commercialisation of this technology appears increasingly feasible, there is growing interest in the research on consumer acceptance of cultured meat. We present a systematic review of the peer-reviewed literature, and synthesize and analyse the findings of 14 empirical studies. We highlight demographic variations in consumer...

Drug-resistant tuberculosis: challenges and opportunities for diagnosis and treatment.

With an estimated incidence of 490000 cases in 2016, multidrug resistant tuberculosis (TB), against which key first-line anti-tuberculars are less efficacious, presents major challenges for global health. Poor treatment outcomes coupled with a yawning treatment gap between those in need of second-line therapy and those who receive it, underscore the urgent need for new approaches to tackle the scourge of drug-resistant TB. Against this background, significant progress has been made in understanding the comp...

Treatment of drug-resistant tuberculosis among people living with HIV.

This review aims to describe the key principles in treatment of drug-resistant tuberculosis (TB) in people living with HIV, including early access to timely diagnostics, linkage into care, TB treatment strategies including the use of new and repurposed drugs, co-management of HIV disease, and treatment complications and programmatic support to optimize treatment outcomes. These are necessary strategies to decrease the likelihood of poor treatment outcomes including lower treatment completion rates and highe...

Moving average quality control: principles, practical application and future perspectives.

Moving average quality control (MA QC) was described decades ago as an analytical quality control instrument. Although a potentially valuable tool, it is struggling to meet expectations due to its complexity and need for evidence-based guidance. For this review, relevant literature and the world wide web were examined in order to (i) explain the basic concepts and current understanding of MA QC, (ii) discuss moving average (MA) optimization methods, (iii) gain insight into practical aspects related to apply...

Rucaparib: a new treatment option for ovarian cancer.

Approximately 50% of high-grade serous ovarian cancers present a deficiency in the pathways involved in homologous recombination (HR). PARP inhibitors prevent single-strand DNA damage repair and determine a progression of the defect towards double-strand breaks, which results in a process known as 'synthetic lethality'. Areas covered: In this review, the authors discuss the efficacy and toxicity of rucaparib either as a single agent or as a maintenance treatment for ovarian cancer. This includes the NGS Fou...

Expanding access to buprenorphine treatment in rural areas with the use of telemedicine.

The opioid epidemic in the United States has resulted in a public health emergency. Medication-assisted treatment (MAT) with methadone and buprenorphine are evidence-based treatments for opioid use disorder. However, numerous barriers hinder access to treatment in rural areas. The use of telemedicine to deliver psychiatric services is demonstrated to be safe and effective; however, limited data exist on the novel application of telemedicine in the delivery of MAT. This report describes the results of a retr...

Adoption of E-Government Applications for Public Health Risk Communication: Government Trust and Social Media Competence as Primary Drivers.

Building upon a framework of the unified theory of acceptance and use of technology, this study explores the determinants of citizens' intentions to use the government's mobile application for public health risk communication. An online survey was conducted with a quota sample of 700 Korean citizens. The results from structural equation modeling suggest that social media competence and trust in government information are primary determinants of willingness to accept the new application and intention to use ...

Pharmacological Properties of Geraniol - A Review.

Geraniol is an acyclic isoprenoid monoterpene isolated from the essential oils of aromatic plants including , and several other plants. The limited source of geraniol from plant isolation cannot fulfill the great demand from the flavor and fragrance industries, which require maximizing geraniol production through biotechnology processes. The diverse activities of geraniol suggested that geraniol could treat various diseases as a promising drug candidate. In order to evaluate the potential of geraniol applie...

Deutetrabenazine for the treatment of Huntington's chorea.

Huntington's disease (HD) is an inherited neurodegenerative disorder for which no disease-modifying treatment is currently available. Only symptomatic treatment can be offered. Chorea is the most common motor manifestation of HD and may interfere with daily activities, reduce quality of life and cause injury. Areas covered: Deutetrabenazine is the first deuterated drug and second drug after tetrabenazine, the classic vesicular monoamine transporter type 2 (VMAT2) inhibitor, to receive approval for the treat...

Matrix Metalloprotease Triggered Bioresponsive Drug Delivery Systems - Design, Synthesis and Application.

Engineering of drug delivery systems has evolved in recent decades from comparably simple designs that merely controlled drug release to complex, often multistage systems that respond to multiple biological or environmental stimuli. Matrix metalloproteases (MMPs) are a family of proteolytic enzymes that are involved in numerous physiologic and pathophysiologic processes, including cancer. Therefore, these enzymes represent highly relevant targets for the development of novel bioresponsive drug delivery syst...

Topical Vehicle Formulations in the Treatment of Acne.

Topical treatment is the mainstay of acne therapy. The most commonly prescribed topical medications for acne include benzoyl peroxide, clindamycin, and retinoids. Despite their effectiveness in treating mild to moderate acne vulgaris, these topical medications are found to be irritating, and are historically associated with poor tolerability and diminished patient adherence. Thus, choosing the right formulation that will be effective and well tolerated is essential. Novel formulations that optimize drug con...

Application of polydopamine in tumor targeted drug delivery system and its drug release behavior.

Inspired by the bionics of marine mussels, polydopamine (PDA), a new polymer with unique physicochemical properties was discovered. Due to its simple preparation, good biocompatibility, unique drug-loading methods, PDA has attracted tremendous attentions in field of drug delivery and imaging, and the combination of chemotherapy and other therapies or diagnostic methods, such as photothermotherapy (PTT), photoacoustic imaging (PAI), magnetic resonance imaging (MRI), etc. As an excellent drug carrier in tumor...

AIEgen based drug delivery systems for cancer therapy.

Fluorescent drug delivery systems provide a means to track drug release, trace processes of translocation, monitor excretion of anticancer agents and predict therapeutic responses. Traditional fluorescent dye-labeled drug delivery systems often suffer from notorious aggregation-caused quenching (ACQ) with greatly impeded imaging performance. The emerging fluorogens with aggregation-induced emission characteristics (AIEgens) have provided an elegant alternative to tackle this challenge. Recently, fluorescent...

Future Brain and Spinal Cord Volumetric Imaging in the Clinic for Monitoring Treatment Response in MS.

Volumetric analysis of brain imaging has emerged as a standard approach used in clinical research, e.g., in the field of multiple sclerosis (MS), but its application in individual disease course monitoring is still hampered by biological and technical limitations. This review summarizes novel developments in volumetric imaging on the road towards clinical application to eventually monitor treatment response in patients with MS.

Congenital Myasthenic Syndromes: a Clinical and Treatment Approach.

Congenital myasthenia syndromes are clinically and genetically heterogeneous but treatable conditions. Careful selection of drug therapy is paramount as the same drug can be effective, ineffective, and even harmful in different congenital myasthenia syndromes. The purpose of this article is to review current treatment options for these conditions.

Poly (amidoamine) (PAMAM) dendrimer mediated delivery of drug and pDNA/siRNA for cancer therapy.

Poly (amidoamine) (PAMAM) dendrimers are well-defined, highly branched macromolecules with numerous active amine groups on the surface. Because of their unique properties, PAMAM dendrimers have steadily grown in popularity in drug delivery, gene therapy, medical imaging and diagnostic application. This review focuses on the recent developments on the application in PAMAM dendrimers as effective carriers for drug and gene (pDNA, siRNA) delivery in cancer therapy, including: a) PAMAM for anticancer drug deliv...

Safety Profile of Benznidazole in the Treatment of Chronic Chagas Disease: Experience of a Referral Centre and Systematic Literature Review with Meta-Analysis.

Benznidazole is the preferred drug for treatment of Chagas disease. However, it is toxic and of limited value in chronic infection.

Adherence interventions and outcomes of tuberculosis treatment: A systematic review and meta-analysis of trials and observational studies.

Incomplete adherence to tuberculosis (TB) treatment increases the risk of delayed culture conversion with continued transmission in the community, as well as treatment failure, relapse, and development or amplification of drug resistance. We conducted a systematic review and meta-analysis of adherence interventions, including directly observed therapy (DOT), to determine which approaches lead to improved TB treatment outcomes.

Nanoemulsions in drug delivery: formulation to medical application.

Nanoscale oil-in-water emulsions (NEs), heterogeneous systems of two immiscible liquids stabilized by emulsifiers or surfactants, show great potential in medical applications because of their attractive characteristics for drug delivery. NEs have been explored as therapeutic carriers for hydrophobic compounds via various routes of administration. NEs provide opportunities to improve drug delivery via alternative administration routes. However, deep understanding of the NE manufacturing and functionalization...

Low-Intensity Interventions to Reduce Depressive Symptoms before Outpatient Psychotherapy - A Systematic Literature Review.

Psychotherapeutic resources are limited, leading to prolonged waiting periods prior to outpatient psychotherapy. Low-intensity interventions have the potential to bridge such treatment gaps. This systematic review aims to identify interventions targeting depressive symptoms implemented prior to outpatient psychotherapy, and to assess their effectiveness and acceptance. 22 studies were identified. Interventions were classified as active waiting, self-help, guided self-help, brief single-strand interventions,...


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