PubMed Journals Articles About "Epizyme Announces Filing Acceptance Drug Application Priority Review" RSS

23:52 EST 16th February 2020 | BioPortfolio

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Showing "Epizyme announces filing acceptance drug application priority review" PubMed Articles 1–25 of 33,000+

Investigation of quality review issues and the association with application characteristics for new drug applications in first-cycle reviews.

Quality, essential in the drug development and approval process, was demonstrated to be a major reason leading to multiple reviews for New Drug Applications (NDAs) submitted to the United States Food and Drug Administration (USFDA). The present study aimed at systematically investigating quality deficiencies described in the first-cycle NDA reviews of the approved drug products to identify the types of concerns and the association between the occurrence of quality deficiencies and the characteristics of the...

Integrating usability and social cognitive theories with the technology acceptance model to understand young users' acceptance of a health information portal.

The past decade has seen the proliferation of health information portals; however, consumer acceptance of the portals has proven difficult and rate of use has been limited. This study developed a consumer acceptance model by integrating usability and social cognitive theories with the technology acceptance model to explain young Internet users' acceptance of health information portals. Participants (n = 201) completed a self-report questionnaire measuring model constructs after attending a usability tes...

A Patent Perspective on Chikungunya.

Chikungunya is a viral disease caused by chikungunya virus (CHIKV) belonging to the Alphavirus genus and transmitted to humans by mosquitoes of Aedes spp. Nearly 40 countries in Asia, Africa, Europe, and the Americas have documented chikungunya cases. Most recent severe outbreaks have occurred in Indian Ocean islands of Réunion and Mauritius and India. There is no specific drug treatment for the disease, neither is there a standardized vaccine available for prevention of the disease. The present review giv...

Factors influencing seniors' acceptance of technology for ageing in place in the post-implementation stage: A literature review.

To identify factors that influence the acceptance of technology for ageing in place by seniors in the post-implementation stage. This review is among very few that focus on acceptance in post-implementation phase.

ANNIVERSARY REVIEW: Octreotide, 40 years later.

Octreotide remains 40 years after its development a drug, which is commonly used in the treatment of acromegaly and GEP-NETs. Very little innovation that competes with this drug occurred over this period. This review discusses several aspects of 40 years of clinical use of octreotide, including the application of radiolabeled forms of the peptide.

The Effect of Eliminating Intermediate Severity Drug-Drug Interaction Alerts on Overall Medication Alert Burden and Acceptance Rate.

 This study aimed to determine the effects of reducing the number of drug-drug interaction (DDI) alerts in an order entry system.

Mindfulness- and acceptance-based interventions for patients with fibromyalgia - A systematic review and meta-analyses.

To analyze health effects of mindfulness- and acceptance-based interventions, including mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy (ACT). Additionally, we aimed to explore content and delivery components in terms of procedure, instructors, mode, length, fidelity and adherence in the included interventions.

Childhood abuse as a risk factor for injection drug use: A systematic review of observational studies.

Childhood abuse is a public health challenge with lifelong impacts, including future drug use. However, previous research has been mixed regarding impacts on injection drug use. This systematic review examines the impact of childhood abuse (sexual, physical and emotional) on adult injection drug use.

Diarylheptanoid: A privileged structure in drug discovery.

Privileged structures are widely used in the process of drug design, and provide an effective template in medicinal chemistry. Diarylheptanoids are a class of structurally distinctive compounds with a wide variety of bioactivity, raising keenly interest in the past decades. Turmeric is a golden spice from the rhizome of the plant Curcuma longa, used for food preparations and giving color since ancient times. Curcumin, obtained from turmeric, has showed widely biological abilities with low toxicity in recent...

Challenges and pitfalls in the development of liposomal delivery systems for cancer therapy.

Despite considerable advances in the application of liposomal drug delivery systems in cancer treatment, the clinical application of liposomal formulations has been limited by many factors. It seems that there is a wide gap between results of experimental studies and clinical application of liposomes. In this review, we discuss barriers which limit the translation of liposomal delivery systems in cancer therapy. The main focus of this review will be on differences between preclinical and clinical studies an...

The adverse-effect profile of lacosamide.

: Lacosamide has been used in epilepsy patients in the United States, Europe and Asia since it was approved by the FDA in 2008. Many patients have benefited from this drug as a new generation of sodium channel blocker. With the worldwide use of this drug, its adverse effects have gradually emerged, especially some rare adverse events.: The present review aims to summarize the adverse effects of lacosamide reported in the literature in recent years to promote the safe clinical application of the drug.: In mo...

Acceptance of Opt-Out HIV Screening in Outpatient Settings in the United States: A Systematic Review and Meta-Analysis.

In the United States, about 15% of persons living with HIV infection do not know they are infected. Opt-out HIV screening aims to normalize HIV testing by performing an HIV test during routine medical care unless the patient declines. The primary objective of this systematic review and meta-analysis was to assess the acceptance of opt-out HIV screening in outpatient settings in the United States.

Evaluation of context-specific alerts for potassium-increasing drug-drug interactions: A pre-post study.

To investigate whether context-specific alerts for potassium-increasing drug-drug interactions (DDIs) in a clinical decision support system reduced the alert burden, increased alert acceptance, and had an effect on the occurrence of hyperkalemia.

Recent advances of drug delivery nanocarriers in osteosarcoma treatment.

Osteosarcoma is the most common primary malignant bone tumor mainly occurred in children and adolescence, and chemotherapy is limited for the side effects and development of drug resistance. Advances in nanotechnology and knowledge of cancer biology have led to significant improvements in developing tumor-targeted drug delivery nanocarriers, and some have even entered clinically application. Delivery of chemotherapeutic agents by functionalized smart nanocarriers could protect the drugs from rapid clearance...

Assessing risk of adverse drug reactions in the elderly: a feasibility study.

Background Adverse drug reactions are common in Australian general practice and can be a cause of, or contribute to, preventable hospital admissions. Developing practical tools to assist in identifying patients who are at high risk of serious adverse drug reactions is an important step in preventing these hospitalisations. Objective The aims of the study were to apply the Prediction of Hospitalisation due to Adverse Drug Reactions in Elderly Community-Dwelling Patients (PADR-EC) Score to assess the risk of...

Preparation and application of dextran and its derivatives as carriers.

As a natural and renewable biological macromolecule, dextran not only has excellent biodegradability, but also has good biocompatibility. Dextran and its derivatives are functional polymers for the construction of targeted drug delivery systems. Herein, the application of dextran as prodrug and nanoparticle/nanogel/microsphere/micelle carrier for targeting drug delivery system was summarized. It is clarified that dextran is an important biomaterial with application value.

Applying priority-setting frameworks: A review of public and vulnerable populations' participation in health-system priority setting.

There is a growing body of literature that describes, applies, and evaluates applications of health-system priority-setting frameworks in different contexts. However, little explicit focus has been given to examining operationalization of the stakeholder participation component of these frameworks. The literature identifies the public as a stakeholder group and recommends their participation when applying the frameworks.

Thermoresponsive polymers and their biomedical application in tissue engineering - a review.

Thermoresponsive polymers hold great potential in the biomedical field, since they enable the fabrication of cell sheets, in situ drug delivery and 3D-printing under physiological conditions. In this review we provide an overview of several thermoresponsive polymers and their application, with focus on poly(N-isopropylacrylamide)-surfaces for cell sheet engineering. Basic knowledge of important processes like protein adsorption on surfaces and cell adhesion is provided. For different thermoresponsive polyme...

Zebrafish embryo as a replacement model for initial biocompatibility studies of biomaterials and drug delivery systems.

The development of new biomaterials and drug delivery systems necessitates animal experimentation to demonstrate biocompatibility and therapeutic efficacy. Reduction and replacement of the requirement to conduct experiment using full-grown animals has been achieved through utilising zebrafish embryos, a promising bridge model between in vitro and in vivo research. In this review, we consider how zebrafish embryos have been utilised to test both the biocompatibility of materials developed to interact with th...

Biomedical application of graphene: From drug delivery, tumor therapy, to theranostics.

The rise of graphene has driven great revolution in various fields, e. g. electronics, device, energy, etc., owing to the well-researched understanding of its physical and chemical properties. In the very recent decade, scientists have poured significant efforts to explore the biological functions of graphene and expand its biomedical applications, including drug delivery, tumor therapy, and theranostics. Encouraged by the inspiring research results and promising contributions of graphene to biomedicine fie...

PBPK models for evaluating membrane transporter mediated DDIs: Current capabilities, case studies, future opportunities and recommendations.

Physiology-based pharmacokinetic (PBPK) modelling has been extensively used to quantitatively translate in vitro data and evaluate temporal effects from drug-drug interactions (DDIs), arising due to reversible enzyme and transporter inhibition, irreversible time-dependent inhibition, enzyme induction, and/or suppression. PBPK modelling has now gained reasonable acceptance with the regulatory authorities for the Cytochrome-P450-mediated DDIs and is routinely used. However, the application of PBPK for transpo...

Structure-based Drug repositioning: Potential and Limits.

Drug repositioning, the assignment of new therapeutic purposes to known drugs, is an established strategy with many repurposed drugs on the market and many more at experimental stage. We review three use cases, a herpes drug with benefits in cancer, a cancer drug with potential in autoimmune disease, and a selective and an unspecific drug binding the same target (GPCR). We explore these use cases from a structural point of view focusing on a deep understanding of the underlying drug-target interactions. We ...

Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways.

Developing a novel drug, including discovery, nonclinical toxicology studies, initial clinical trials, and thorough pivotal studies, may take many years. Once an applicant has generated this comprehensive body of data, the final step prior to regulatory approval is Health Authority review of the marketing authorization application. Review by regulatory authorities to evaluate whether the data support a positive benefit/risk profile takes many months, adding additional time before patients may access therapy...

A Review On Role of polymers in Pharmaceutical Applications.

Development of new drug molecule is costly and requires long time. Many of attempts have been done to improve safety effectiveness level of "old" drugs, utilizing various ways like individualizing drug therapy, curative drug control, and dose titration. But, Recently an important efforts have been pointed to discover novel drug releasing systems, in which it can be supplied to a target system in human body, with controlling the level and time of delivery. Polymers, whether synthetic or natural, have a great...

Tooth detection and classification on panoramic radiographs for automatic dental chart filing: improved classification by multi-sized input data.

Dental state plays an important role in forensic radiology in case of large scale disasters. However, dental information stored in dental clinics are not standardized or electronically filed in general. The purpose of this study is to develop a computerized system to detect and classify teeth in dental panoramic radiographs for automatic structured filing of the dental charts. It can also be used as a preprocessing step for computerized image analysis of dental diseases.

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