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Drug Approvals Research

07:38 EST 15th November 2018 | BioPortfolio

Role of Health Technology Assessment in Drug Policies: Korea.

South Korea is the first Asian country to mandate the submission of pharmacoeconomic data for reimbursement decision making. For a new drug to be listed, it must demonstrate its value in terms of comparative effectiveness and cost effectiveness. The Health Insurance Review and Assessment Service (HIRA) judges the submitted drug's value and decides whether its coverage is appropriate on the basis o...

Facile synthetic Photoluminescent Graphene Quantum dots encapsulated β-cyclodextrin drug carrier system for the management of macular degeneration: Detailed analytical and biological investigations.

Drug administration by effective nano-carriers is an emerging and growing technology in the field of bio-medicine and particularly Age -related macular degeneration (AMD). This developed nanomaterials based methods with drug administration maximizes the biocompatibility and systemically increases drug delivery profile for the drugs. Herein, we described the effective drug molecules delivery profil...

Isoform-Dependent Changes in Cytochrome P450-Mediated Drug Metabolism after Portal Vein Ligation in the Rat.

Surgical removal of complicated liver tumors may be realized in two stages via selective portal vein ligation, inducing the atrophy of portally ligated lobes and the compensatory hypertrophy of nonligated liver lobes. Unlike morphological changes, functional aspects such as hepatic cytochrome P450 (CYP)-mediated drug metabolism remain vaguely understood, despite its critical role in both drug biot...

Groups of coevolving positions provide drug resistance to Mycobacterium tuberculosis: a study using targets of first-line antituberculosis drugs.

Drug resistance has been associated with point mutations in the coding regions, which lead to an altered protein sequence and structure. Such changes have been seen as isolated events which occur at various positions in a sequence. However, we hypothesize that it is not a single mutation at a specific position instead a group of positions which coevolve in a correlated fashion to increase the fitn...

Co-delivery of paclitaxel and cisplatin in poly(2-oxazoline) polymeric micelles: Implications for drug loading, release, pharmacokinetics and outcome of ovarian and breast cancer treatments.

Concurrent delivery of multiple drugs using nanoformulations can improve outcomes of cancer treatments. Here we demonstrate that this approach can be used to improve the paclitaxel (PTX) and alkylated cisplatin prodrug combination therapy of ovarian and breast cancer. The drugs are co-loaded in the polymeric micelle system based on amphiphilic block copolymer poly(2-methyl-2-oxazoline-block-2-buty...

No effect of attentional bias modification training in methamphetamine users receiving residential treatment.

Attentional bias toward drug-related stimuli is a feature of drug addiction that is linked to craving and drug-seeking behavior.

Patient-reported outcomes with golimumab in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: non-interventional study GO-NICE in Germany.

The TNF inhibitor golimumab (GLM) is a treatment option in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). The GO-NICE study assessed patient-reported outcomes (PRO) in patients newly treated with monthly GLM 50 mg subcutaneously (SC) under real-life conditions in Germany. A prospective non-interventional study with 24-month observation per pat...

Use of human induced pluripotent stem cell-derived cardiomyocytes to assess drug cardiotoxicity.

Cardiotoxicity has historically been a major cause of drug removal from the pharmaceutical market. Several chemotherapeutic compounds have been noted for their propensities to induce dangerous cardiac-specific side effects such as arrhythmias or cardiomyocyte apoptosis. However, improved preclinical screening methodologies have enabled cardiotoxic compounds to be identified earlier in the drug dev...

Successful and safe long-term treatment of cerebral aspergillosis with high-dose voriconazole guided by therapeutic drug monitoring.

We report the case of a patient who had cerebral aspergillosis after otorhinolaryngologic surgery and who was successfully and safely treated with high-dose voriconazole (200 mg q6h) for more than 1 year thanks to a TDM-guided approach coupled with pharmacological review and with genotyping of CYP2C19 polymorphisms. The findings support the idea that personalized medicine based on TDM coupled wi...

Effect of baseline renal and hepatic function on the incidence of adverse drug events: the Japan Adverse Drug Events study.

Background The impact of renal and hepatic dysfunction on the morbidity and mortality of inpatients with adverse drug events (ADEs) is uncertain in daily clinical practice. The objective of this study was to investigate the effect of renal and hepatic function on ADEs and inpatients' morbidity and mortality. Methods The Japan Adverse Drug Events (JADE) study was a prospective cohort study carried ...

Generating Model Integrated Evidence for Generic Drug Development and Assessment.

Quantitative methods and modeling (QMM) covers a broad spectrum of toolsets of which physiologically-based models and quantitative clinical pharmacology are most critical for generic drugs. QMM has been increasingly applied by the U.S. Food and Drug Administration (FDA) to facilitating generic drug development and review, and has played a critical role in the modernization of bioequivalence (BE) a...

Electric field-responsive nanoparticles and electric fields: Physical, chemical, biological mechanisms and therapeutic prospects.

Electric fields are among physical stimuli that have revolutionized therapy. Occurring endogenously or exogenously, the electric field can be used as a trigger for controlled drug release from electroresponsive drug delivery systems, can stimulate wound healing and cell proliferation, may enhance endocytosis or guide stem cell differentiation. Electric field pulses may be applied to induce cell fu...

Enhancing oral bioavailability of poorly soluble drugs with mesoporous silica based systems: opportunities and challenges.

Porous silica based drug delivery systems have shown considerable promise for improving the oral delivery of poorly water-soluble drugs. More specifically, micro- and meso-porous silica carriers have high surface areas with associated ability to physically adsorb high drug loads in a molecular or amorphous form; this allows molecular state drug release in aqueous gastro-intestinal environments, po...

The π-π stacking-guided supramolecular self-assembly of nanomedicine for effective delivery of antineoplastic therapies.

In traditional nano drug-delivery systems, the complex chemical bonds between drug and carrier often complicate the preparation process and are less prone to rupture upon entry into the target, which is detrimental to the timely release of the drug. The π-π stacking provides us with a promising alternative as it is a weak interaction between the aromatic rings. Since most antitumor drugs are hyd...

Miltefosine enhances the fitness of a non-virulent drug-resistant Leishmania infantum strain.

Miltefosine is currently the only oral drug for visceral leishmaniasis, and although deficiency in an aminophospholipid/miltefosine transporter (MT) is sufficient to elicit drug resistance, very few naturally miltefosine-resistant (MIL-R) strains have yet been isolated. This study aimed to make a detailed analysis of the impact of acquired miltefosine resistance and miltefosine treatment on in viv...

Incurred sample reanalysis (ISR) in drug discovery bioanalysis.

Bioanalysis plays a key role during drug discovery process to generate the pharmacokinetic data to facilitate unbiased evaluation of leads, optimized leads and drug candidates. Such pharmacokinetic data are used to enable key decisions in the drug discovery process. The aim of the work is to put forward a new strategy of performing the incurred sample reanalysis (ISR) for select small molecule Nov...

Incidence of single-drug-, multidrug-, and extensively drug-antimicrobial resistance of Escherichia coli urinary tract infections: an Australian laboratory-based retrospective study.

To evaluate incidence of single-drug resistant, multidrug-resistant, extensively drug-resistant and pandrug-resistant E. coli urinary tract infections (UTI) in a sample of Australian Capital Territory (ACT) residents.

Noninvasive Ultrasonic Drug Uncaging Maps Whole-Brain Functional Networks.

Being able to noninvasively modulate brain activity, where and when an experimenter desires, with an immediate path toward human translation is a long-standing goal for neuroscience. To enable robust perturbation of brain activity while leveraging the ability of focused ultrasound to deliver energy to any point of the brain noninvasively, we have developed biocompatible and clinically translatable...

Ethanol→Nicotine & Nicotine →Ethanol Drug-Sequence Discriminations: Conditional Stimulus Control with Two Interoceptive Drug Elements in Rats.

Self-administration of Ethanol (E) and nicotine (N) occurs frequently in tandem orders (i.e., N→E vs. E→N) and thereby produce differing interoceptive profiles of subjective effects in humans. If the interoceptive stimulus characteristics of N→E differ from E→N, it is possible that such differences contribute to their co-dependence. The rationale for the present investigation was to determ...

Identification of Factors Associated with First-Cycle Drug Approval Rates and Regulatory Outcomes for New Drug Applications.

The aims of this study were to identify types of deficiencies resulting in delay of approvals for drugs eventually approved by the US FDA and to search for factors associated with higher first-cycle approval rates. Review documents of New Drug Applications approved between 2008 and 2017 were retrieved from the Drugs@FDA database. Basic characteristics of the applications, regulatory actions, and r...

A life with seizures: Argentine patients' perspectives about the impact of drug-resistant epilepsy on their lives.

To understand the experience of drug-resistant epilepsy in patients from Argentina, a developing nation.

Cancer Theranostic Applications of Albumin-Coated Tobacco Mosaic Virus Nanoparticles.

Nanotechnology holds great promise in cancer drug delivery, and of particular interest are theranostic approaches in which drug delivery and imaging are integrated. In this work, we studied and developed the plant virus tobacco mosaic virus (TMV) as a platform nanotechnology for drug delivery and imaging. Specifically, a serum albumin (SA)-coated TMV formulation was produced. The SA coating fulfil...

Alcohol amination catalyzed by copper powder as a self-supported catalyst.

Catalytic alcohol amination is a sustainable reaction for N-alkyl amine synthesis. In the past research, homogeneous and supported copper catalysts have been extensively studied and nice resutls were obtained. In this work, we'd like to show that copper powder can behave as an active catalyst for the alcohol amination, and its catalytic performance was better than the oxides supported nano-copper ...

Organizational uptake of NICE guidance in promoting employees' psychological health.

Annual costs to organizations of poor mental health are estimated to be between £33 billion and £42 billion. The UK's National Institute for Clinical Excellence (NICE) has produced evidence-based guidance on improving employees' psychological health, designed to encourage organizations to take preventative steps in tackling this high toll. However, the extent of implementation is not known outsi...

A Trial of a Triple-Drug Treatment for Lymphatic Filariasis.

The World Health Organization has targeted lymphatic filariasis for global elimination by 2020 with a strategy of mass drug administration. This trial tested whether a single dose of a three-drug regimen of ivermectin plus diethylcarbamazine plus albendazole results in a greater sustained clearance of microfilariae than a single dose of a two-drug regimen of diethylcarbamazine plus albendazole and...

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