PubMed Journals Articles About "To Compare The Safety And Efficacy Of Perrigo's Product To An FDA Approved Product For The Treatment Of Secondarily Infected Traumatic Skin Lesions" RSS

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Showing "Compare Safety Efficacy Perrigo Product Approved Product Treatment" PubMed Articles 1–25 of 38,000+

The Safety and Efficacy of a Novel Cell-Based Gene Therapy for Knee Osteoarthritis.

A promising new gene technology has been developed for the treatment of osteoarthritis, utilizing transduced human cells expressing transforming growth factor-β1. The safety and efficacy of this treatment modality has been demonstrated in laboratory studies, as well as Phase I, II, and current Phase III human clinical trials. Due to a misidentification error, there have been concerns that this cell-based gene therapy is based on a different cell than the one that was initially approved. However, its safety...

Cost savings associated with timely treatment of botulism with botulism antitoxin heptavalent product.

Botulism is a rare, serious, and sometimes fatal paralytic illness caused by exposure to neurotoxins produced by Clostridium botulinum bacteria. Patients with documented or suspected exposure to botulinum toxin serotypes A-G can be treated with BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine)] product, which was approved in 2013 in the United States (US). Patients with botulism have demonstrated greater clinical benefit with early BAT product treatment (≤2 days from symptom onset) vers...

Comparative Physicochemical and Biological Characterisation of the Similar Biological Medicinal Product Teriparatide and Its Reference Medicinal Product.

In January 2017, the European Commission approved Terrosa (company code RGB-10) as one of the first biosimilar medicinal products of teriparatide for the same indications as for the reference medicinal product Forsteo (Lilly France S.A.S.), which has been on the market in the European Union since 2003. The active pharmaceutical ingredient of the reference medicinal product is the biologically active 1-34 fragment of the endogenous human parathyroid hormone [PTH(1-34)]. It is one of the three bone anabolic a...

Effectiveness and safety of Chinese herbal medicine Xiaoyao san for the treatment of insomnia: Protocol for a systematic review and meta-analysis.

Insomnia is one of the most common sleep problems, which can impact physical and mental quality of life, resulting in a heavy social and economic burden. Xiaoyao san, a Chinese Herbal Medicine product, has been widely used as an alternative to recommended treatments for insomnia, but still lack of evidence of evidence-based medicine, which the clinical efficacy and its safety are questioned. Accordingly, we provide a protocol to evaluate the efficacy and safety of Xiaoyao san to update the search and evalua...

Efficacy is Not Everything: Eliciting Women's Preferences for a Vaginal HIV Prevention Product Using a Discrete-Choice Experiment.

As new female-initiated HIV prevention products enter development, it is crucial to incorporate women's preferences to ensure products will be desired, accepted, and used. A discrete-choice experiment was designed to assess the relative importance of six attributes to stated choice of a vaginally delivered HIV prevention product. Sexually active women in South Africa and Zimbabwe aged 18-30 were recruited from two samples: product-experienced women from a randomized trial of four vaginal placebo forms and p...

Evaluation of commercially available meth-deterrent pseudoephedrine hydrochloride products.

Pseudoephedrine (PSE) extracted from its dosage forms can be used as the starting material to prepare methamphetamine by drug abusers. Recently, some pseudoephedrine drug products marketed under the over the counter (OTC) monograph have been promoted as 'meth-deterrent'. The goal of this investigation was to evaluate the extraction and dissolution of these product against controls of non-meth-deterrent products of pseudoephedrine. Immediate release (IR) PSE OTC Product-C, Product-D and Product-E with meth-d...

Efficacy and Safety of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, for the Treatment of Keratoconjunctivitis Sicca: Pooled Analysis of a Phase 2b/3 and Phase 3 Study.

OTX-101 (CEQUA™) is approved in the United States for treatment of keratoconjunctivitis sicca (KCS). This pooled analysis of 2 studies (phase 2b/3 and phase 3) evaluates the efficacy and safety of OTX-101 0.09% in the intent-to-treat (ITT) population and the subgroup of patients with a baseline Schirmer score less than 10 mm.

Efficacy of Topical Botanical Treatment of Children With Mild to Moderate Atopic Dermatitis

Objective: The study was conducted to determine the efficacy of the botanical combination incorporated in Kamedis Eczema Therapy Cream (the test product) for children with mild to moderate atopic dermatitis. Design: The study was designed as an interventional, multi-center, double-blind, randomized, controlled study. Setting: Children subjects were a sub-population of the 108 combined population of adults and children evenly randomly divided into three treatment groups: test product, vehicle, and comparat...

Transport of pharmaceuticals during electrodialysis treatment of wastewater.

Electrodialysis (ED) is a promising emerging electrochemical membrane technology for nutrient concentration and recovery from wastewater. However associated environmental safety aspects have to be assessed before utilizing concentrated nutrient produced by ED, for instance as fertilizer. Municipal wastewaters contain various micropollutants that have the potential of being concentrated during the ED treatment processes. This study quantified the transport of pharmaceuticals during ED nutrient recovery from ...

Dolutegravir and lamivudine vs other antiviral regimens in HIV-1 treatment-naïve patients: a systematic review and network meta-analysis.

Compare the efficacy and safety of the 2-drug antiretroviral therapy (ART) regimen dolutegravir + lamivudine (DTG+3TC) with traditional 3-drug regimens in treatment-naïve patients with HIV-1.

Are Biosimilars the Future of Oncology and Haematology?

Biological drugs are vital but often high-cost components of cancer treatment. Several biosimilar versions of these drugs have been approved in Europe and/or the USA, with many more in development. However, there is some disconnect between the biosimilars that are approved for use and those accessible in clinical practice, with availability impacted by factors including patent litigation and complex healthcare insurance policies, particularly in the USA. Provided the barriers to widespread uptake can be ove...

Analysis of Immunogenicity Data in the Product Information of Biological Drugs: A Need to Report Immunogenicity Data Systematically.

The aim of this analysis was to evaluate whether the current unsystematic assessment leads to sufficient reporting of immunogenicity-related information in the Summary of Product Characteristics (SmPCs) of biological products approved in the European market.

Adolescents' first tobacco products: Associations with current multiple tobacco product use.

Understanding which tobacco products adolescents use first can lead to insights for tobacco prevention interventions and policies. We used cross-sectional data from high school students who reported ever using a tobacco product from the 2017 North Carolina Youth Tobacco Survey (n = 1,053). In multivariable regressions, we examined how demographic and psychosocial factors were associated with adolescents' first product tried and how first product tried was associated with current tobacco use (i.e., no use, u...

Efficacy and Safety of an Expanded Dulaglutide Dose Range: A Phase 2, Placebo-controlled Trial in Patients with Type 2 Diabetes on Metformin.

Dulaglutide, a once weekly GLP-1 receptor agonist, is approved at 2 doses (1.5 mg and 0.75 mg) for treatment of type 2 diabetes (T2D). Two higher dulaglutide doses (3.0 and 4.5 mg) were evaluated for safety and efficacy to determine if these doses warrant further study for improved glucose and body weight control.

Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Adolescents with Chronic HCV: Part 1 of the DORA Study.

The pangenotypic regimen of glecaprevir and pibrentasvir (G/P) is approved to treat adults with chronic hepatitis C virus (HCV) infection, and has yielded high cure rates in adults in clinical trials. Approved treatment options for pediatrics may include ribavirin (RBV). A pangenotypic regimen for pediatric patients remains an unmet need. DORA is an ongoing phase 2/3, non-randomized, open-label study evaluating the pharmacokinetics (PK), safety, and efficacy of G/P in pediatric patients with chronic HCV. Th...

Perceived Relative Harm of Using E-Cigarettes Predicts Future Product Switching among U.S. Adult Cigarette and E-Cigarette Dual Users.

People's perceptions of the harmfulness of e-cigarettes, compared with cigarettes, may influence their product use decisions. We tested if perceiving e-cigarettes as less harmful than cigarettes predicted whether cigarette and e-cigarette dual users switched their product use status one year later, becoming exclusive e-cigarette users, exclusive cigarette smokers, or non-users of both product types.

Prevalence Of Unplanned Readmissions Among Patients Of Military Treatment Facilities.

Understanding readmissions within the Military Health System (MHS) provides important insights to better understand and improve health outcomes for military personnel and their families. We assessed all-cause seven- and thirty-day readmission rates in military treatment facilities by treatment service for patients ages 18-64 for fiscal years 2011-18 using inpatient data from the MHS and the private sector. We compared unplanned readmission rates for the obstetric, medical, and surgical product lines. Readmi...

Deutetrabenazine for tardive dyskinesia and chorea associated with Huntington's disease: a review of clinical trial data.

: Huntington's disease (HD)-associated chorea and tardive dyskinesia (TD) are hyperkinetic movement disorders that can have deleterious effects on patients' quality of life (QoL). Deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, was approved by the US Food and Drug Administration (FDA) for the treatment of HD-associated chorea and TD. It is structurally similar to tetrabenazine, an FDA-approved compound for treatment of chorea that is widely used off-label for treatment of TD, but ha...

Device profile of the Nerivio for acute migraine treatment: overview of its efficacy and safety.

Non-invasive neuromodulation devices represent an emerging field in the acute treatment of migraine. High efficacy, favorable safety profile, good tolerability and low cost are important factors for the desired shift to non-pharmacological treatments. This will have the potential to improve the quality of life of people with migraine and reduce the risk for adverse events and medication overuse headache (MOH). Nerivio™ (Theranica Bio-Electronics, Israel) is a novel FDA-cleared remote electrical neuromodul...

Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks.

Botulinum neurotoxin (BoNT) is an effective treatment for chronic sialorrhea; however, reliable and robust evidence supporting long-term efficacy and safety is lacking. This study investigated the efficacy and safety of repeated incobotulinumtoxinA injections for chronic sialorrhea over 64 weeks.

Sunscreen claims, risk management and consumer confidence.

This essay is a personal reflection on how the concept of risk is impacting on the development of sunscreen products and claims, and whether these developments are jeopardising consumer confidence. In order to estimate the risk of harm, we need not only to identify a hazard but, as importantly, determine the degree of exposure to the hazard and understand the health of impact of consequent exposure. A practice by many manufacturers is simply to market a product that claims to be protective against a hazard ...

Impact of a Probiotic Product on Bowel Habits and Microbial Profile in Subjects with Functional Constipation: A Randomized Controlled Trial.

To investigate the clinical efficacy of a multi-strain probiotic product on bowel habits and microbial profile in subjects with functional constipation.

Risk factors for multiple tobacco product use among high school youth.

To examine how youth multiple tobacco product (MTP) users differ relative to non-users and to single-product users on risk factors at multiple levels of influence.

Identification and characterization of co-purifying CHO host cell proteins in monoclonal antibody purification process.

Host cell proteins (HCPs) are process-related impurities derived from the host organism such as Chinese hamster ovary (CHO) cells used for the production of therapeutic mAbs in biopharmaceuticals and potentially pose a risk to patient safety and product efficacy. A number of HCPs have been reported as exceptionally difficult to remove and persist across downstream purification operations into final drug product because they exhibit association with mAbs. Therefore, understanding of HCP impurities and the mA...

Assessing the impact of product inhibition in a chromogenic assay.

Chromogenic substrates (CS) are synthetic substrates used to monitor the activity of a target enzyme. It has been reported that some CSs display competitive product inhibition with their target enzyme. Thus, in assays where enzyme activity is continuously monitored over long periods of time, the product inhibition may significantly interfere with the reactions being monitored. Despite this knowledge, it is rare for CSs to be directly incorporated into mathematical models that simulate these assays. This dev...

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