Drug Approvals Research

11:18 EDT 15th August 2018 | BioPortfolio

Exploring factors for the design of nanoparticles as drug delivery vectors.

In order to achieve the optimal results when employing nanoparticles in biomedical fields, choosing the right type of nanoparticle and determining the correct procedure for drug loading are key factors. Each type of nanoparticle presents a determined set of characteristics that are, in some cases, unique. In general, their surface charge, geometry or hydrophilic character may be limiting factors, ...

National survey of imaging practice for suspected or confirmed plasma cell malignancies.

Cross-sectional imaging is now recommended by the National Institute for Health and Care Excellence (NICE) for patients with suspected and newly diagnosed myeloma instead of skeletal survey. The objectives of this study were: (1) To evaluate compliance of current UK imaging practice with reference to national NICE best-practice clinical guidelines for plasma cell malignancies. (2: To identify fact...

Extended cell and plasma drug levels after one dose of a 3-in-1 nanosuspension containing lopinavir, efavirenz, and tenofovir in non-human primates.

To characterize a drug-combination nanoparticle (DcNP) containing water-insoluble lopinavir (LPV) and efavirenz (EFV), and water-soluble tenofovir (TFV), for its potential as a long-acting combination HIV treatment.

From stroke to neurodegenerative diseases: The multi-target neuroprotective effects of 3-n-butylphthalide and its derivatives.

Discovering effective agents to slow or stop neurodegeneration is a challenging task. Over decades, only a few drugs were approved by Food and Drug Administration (FDA) and most ended in failure. The lessons learned have switched the strategy of drug discovery from designing highly selective ligands to a network pharmacology approach. This enables many natural products like butylphthalide (NBP) on...

Extrusion 3D Printing of Paracetamol Tablets from a Single Formulation with Tunable Release Profiles Through Control of Tablet Geometry.

An extrusion-based 3D printer was used to fabricate paracetamol tablets with different geometries (mesh, ring and solid) from a single paste-based formulation formed from standard pharmaceutical ingredients. The tablets demonstrate that tunable drug release profiles can be achieved from this single formulation even with high drug loading (> 80% w/w). The tablets were evaluated for drug release u...

5-Aminolevulinic acid fluorescence guided surgery for recurrent high-grade gliomas.

Fluorescence guided surgery (FGS) with five-aminolevulinic acid (5-ALA) is expected to revolutionize neurosurgical care of patients with high-grade gliomas (HGG). After the recent landmark FDA approval, this optical agent is now available to neurosurgeons in the United States.

A large single hospital experience using drug provocation testing and rapid drug desensitization in hypersensitivity to antineoplastic and biological agents.

Large-scale studies of Drug Provocation Testing (DPT) or Rapid Drug Desensitization (RDD) for hypersensitivity to antineoplastics and biologicals are scarce and limited to a few institutions OBJECTIVE: Our aim was to review our experience with DPT and RDD in a large number of patients with a history of hypersensitivity to antineoplastics and biologicals and summarize the practical implications of ...

Illicit drug use and work in a model therapeutic workplace.

The link between illicit drug use and impaired employee performance in the workplace has been assumed, but the relation has not been demonstrated clearly in research. This study was an evaluation of the relations between cocaine and opiate use, attendance, and performance in a job skills training program in a population with high rates of drug use.

The Rise and Fall of Mesh in Pelvic Surgery and the Shortcomings of Medical Device Regulation.

Two U.S. Food and Drug Administration public health warnings regarding the use of mesh in stress incontinence and prolapse repairs have had far-reaching clinical and legal consequences. In this commentary, we explore the drastically distinct results from these mesh-based procedures, which revealed systemic flaws with the medical device approval process across specialties and affected thousands of ...

Therapeutic Drug Monitoring of Levetiracetam in Select Populations.

Levetiracetam (LEV) is a broad spectrum antiepileptic drug (AED) that has a more favorable side effect profile compared to older AEDs. Therapeutic drug monitoring (TDM) of LEV is generally unnecessary given its linear and predictable dose-serum concentration relationship, lack of drug-drug interactions, and broad therapeutic window. However, there is growing evidence showing that alteration of LEV...

Increasing prevalence of self-reported HIV pre-exposure prophylaxis (PrEP) use in published surveys - a systematic review and meta-analysis.

: When combining results from all published surveys, about one in nine global study participants (10.7%) reported ever using PrEP by 2017, a significant increase since U.S. FDA approval in 2012 (OR = 1.6/year, p 

Three-Component Mixture Model-Based Adverse Drug Event Signal Detection for the Adverse Event Reporting System.

The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is an important source for detecting adverse drug event (ADE) signals. In this article, we propose a three-component mixture model (3CMM) for FAERS signal detection. In 3CMM, a drug-ADE pair is assumed to have either a zero relative risk (RR), or a background RR (mean RR = 1), or an increased RR (mean RR >1). By c...

Is the priority review voucher program stimulating new drug development for tropical diseases?

Congress created the tropical disease priority review voucher program to stimulate new drug development for tropical diseases. An analysis of the pharmaceutical pipeline indicates that the development of drugs for these tropical diseases has increased. However, the effects of the program are not uniform across all diseases, as malaria and tuberculosis have seen significant new drug development, wh...

The effect on the immunology laboratory of the expansion in complement therapeutics.

The approval in the US and Europe of Eculizumab in 2007 marked a change in complement therapeutics, and with it the landscape for complement testing in the clinical immunology laboratory changed. The change had begun even before that when C1-Inhibitor preparations were approved in the 1980s in Europe. There are now two classes of approved drugs that may impact the immunology laboratory, with two d...

Drug-coated vs. Plain Balloon Angioplasty in Bypass Vein Grafts (the DRECOREST I-study).

Stenosis is a known complication in bypass vein grafts for peripheral arterial disease (PAD). The aim of this study was to evaluate the effect of drug-coated balloons (DCB) in the treatment of vein graft stenoses.

The NICE classification for "Ultra-radical (extensive) surgery for advanced ovarian cancer" guidance does not meaningfully predict post-operative complications: a cohort study.

To determine which descriptors of cytoreductive surgical extent in advanced ovarian cancer(AOC) best predict post-operative morbidity.

The Fas Signaling Pathway Is a Common Genetic Risk Factor for Severe Cutaneous Drug Adverse Reactions Across Diverse Drugs.

Human leukocyte antigen (HLA) has been recognized as the most important genetic risk factor for severe cutaneous adverse drug reactions (SCARs) caused by certain drugs. However, cumulated observations suggest the presence of genetic risk factors for SCARs other than drug-specific HLA. We aimed to identify a common genetic risk factor of SCARs across multiple drugs.

Glycol Chitin/PAA Hydrogel Composite Incorporated Bio-functionalized PLGA Microspheres Intended for Sustained Release of Anticancer Drug Through Intratumoral Injection.

A novel anti-hepatoma drug release hybrid system is prepared by using poly(acrylic acid) (PAA) and glycol chitin as substrate in combination with Paclitaxel (PTX)-loaded bio-biofunctionalized poly(lactic-co-glycolic acid) (PLGA) micro-particles, which is intended for cancer therapy through intratumoral injection. The rheological behavior of glycol chitin (7 wt%)/PAA illustrates that it has low g...

Radiopharmaceutical enhancement by drug delivery systems: A review.

Drug delivery systems are entities designed to alter the biological behaviour of the pharmaceutical active ingredients that they carry in order to afford more beneficial biodistribution and safety profiles. Many problems currently faced by the field of nuclear medicine (e.g. developing new theranostic agents, utilizing multimodal imaging platforms and providing targeted delivery) can be facilitate...

Ligand conjugation: An emerging platform for enhanced brain drug delivery.

The drug delivery across the brain has always been problematic due to the tight junction present namely the blood brain barrier (BBB). BBB only allows selected pharmaceutical drugs to get across it and reach the brain via lipid free diffusion process and exert their therapeutic effect. This leads to the decrease in drug accessibility to brain. More recently, various approaches were employed to all...

In vitro and in vivo experimental models employed in the discovery and development of antiepileptic drugs for pharmacoresistant epilepsy.

Epilepsy is one of the most common chronic, recurrent and progressive neurological diseases. In spite of the large number of antiepileptic drugs currently available for the suppression of seizures, about one-third of patients develop drug-resistant epilepsy, even when they are administered the most appropriate treatment available. Thus, nonclinical models can be valuable tools for the elucidation ...

Chinese approval for Ascletis' HCV drug is first homegrown success.

Clinical trials on drug-drug interactions registered in reported incongruent safety data in published articles: an observational study.

To assess safety data of trials on DDIs reported in and published in journal articles, since drug-drug interactions (DDIs) are a growing concern.

Mitochondrial permeability transition pore: a potential drug target for neurodegeneration.

The mitochondrial permeability transition pore (mPTP) has been considered a key contributor to cell death, inducing the process in several major neurodegenerative diseases. To date, the molecular nature of the mPTP remains confounding but its significance is universally acknowledged. Several targets have been screened and inhibition of mPTP has emerged as an attractive field for researchers. Nowad...

Predict effective drug combination by deep belief network and Ontology Fingerprints.

The synergistic effect of drug combination is one of the most desirable properties for treating cancer. However, systematically predicting effective drug combination is a significant challenge. We report here a novel method based on deep belief network to predict drug synergy from gene expression, pathway and the Ontology Fingerprints-a literature derived ontological profile of genes. Using data s...

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