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FDA Research

00:48 EST 22nd November 2017 | BioPortfolio

Strengthening Global Surveillance for Antimicrobial Drug-Resistant Neisseria gonorrhoeae through the Enhanced Gonococcal Antimicrobial Surveillance Program.

Monitoring trends in antimicrobial drug-resistant Neisseria gonorrhoeae is a critical public health and global health security activity because the number of antimicrobial drugs available to treat gonorrhea effectively is rapidly diminishing. Current global surveillance methods for antimicrobial drug-resistant N. gonorrhoeae have many limitations, especially in countries with the greatest burden o...

Drug Overdose Deaths Among Adolescents Aged 15-19 in the United States: 1999-2015.

Data from the National Vital Statistics System ● The death rate due to drug overdose among adolescents aged 15-19 more than doubled from 1999 (1.6 per 100,000) to 2007 (4.2), declined by 26% from 2007 to 2014 (3.1), and then increased in 2015 (3.7). ● The drug overdose death rate increased between 1999 and the mid-2000s for both males and females but only males had a subsequent decline between...

Efficacy of selective serotonin reuptake inhibitors in the absence of side effects: a mega-analysis of citalopram and paroxetine in adult depression.

It has been suggested that the superiority of antidepressants over placebo in controlled trials is merely a consequence of side effects enhancing the expectation of improvement by making the patient realize that he/she is not on placebo. We explored this hypothesis in a patient-level post hoc-analysis including all industry-sponsored, Food and Drug Administration-registered placebo-controlled tria...

Cyclic peptide-polymer nanotubes as efficient and highly potent drug delivery systems for organometallic anticancer complexes.

Functional drug carrier systems have potential for increasing solubility and potency of drugs while reducing side effects. Complex polymeric materials, particularly anisotropic structures, are especially attractive due to their long circulation times. Here, we have conjugated cyclic peptides to the biocompatible polymer poly(2-hydroxypropyl methacrylamide) (pHPMA). The resulting conjugates were fu...

How can one optimize induction therapy in AML?

Induction therapy for acute myeloid leukemia has not changed much since 1973, when the 7 + 3 regimen of cytarabine and daunorubicin was born. Since then, various strategies have been evaluated to improve patient response, including dose intensification, the incorporation of additional agents into the regimen, the development of novel agents, and modified approaches for older patients. Recently, ...

Context and characteristics of illicit drug use in coastal and interior Tanzania.

An increase in heroin seizures in East Africa may signal wider local consumption of illicit drugs. Most information about drug use in Tanzania is from the economic capital, Dar es Salaam, and well-travelled Zanzibar. More data are needed on the extent, trends, and characteristics of illicit drug use in the vast coast and interior of the country.

Asiatic acid and maslinic acid attenuated kainic acid-induced seizure through decreasing hippocampal inflammatory and oxidative stress.

Seizure is a neurological disorder including hippocampal oxidative and inflammatory stress, and glutamate toxicity. Thus, any agent(s) that mitigate(s) these events in hippocampus might attenuate seizure severity. The effects of asiatic acid (AA) or maslinic acid (MA) pre-administration at 20 or 40mg/kg body weight/day upon inflammatory, oxidative and apoptotic injury in hippocampus of kainic acid...

'I have it just in case' - Naloxone access and changes in opioid use behaviours.

The past decade has seen over a four-fold increase in deaths from opioid overdose in the United States. To address this growing epidemic, many localities initiated policies to expand access to naloxone (a drug that reverses the effects of opioids); however, little is known how naloxone access affects opioid use behaviours.

Nine reasons why ecstasy is not quite what it used to be.

This paper explores the recent resurgence in use of ecstasy/MDMA in Europe and highlights keys areas of continuity and divergence between the ecstasy market of the 1990s and the current MDMA market. Based on a scoping study involving a targeted multi-source data collection exercise on MDMA, it highlights nine areas that have undergone some level of change, linked with both supply and demand for th...

Effect of initiating drug treatment on the risk of drug-related poisoning death and acquisitive crime among offending heroin users.

A recent Cochrane review of randomised trials identified a lack of evidence for interventions provided to drug-using offenders. We use routine data to address whether contact with treatment services reduces heroin users' likelihood of a future acquisitive offence or drug-related poisoning (DRP) death.

Patterns of food and physical activity environments related to children's food and activity behaviors: A latent class analysis.

Relationships between food and physical activity (PA) environments and children's related behaviors are complex. Latent class analyses derived patterns from proximity to healthy and unhealthy food outlets, PA facilities and parks, and counts of residential dwellings and intersections. Regression analyses examined whether derived classes were related to food consumption, PA, and overweight among 40...

Ensuring quality pharmacokinetic analyses in antimicrobial drug development programs.

Pharmacokinetic studies and analyses can be expensive, time consuming, and labor intensive. However, it is crucial to understand that much of what happens in antimicrobial drug development, such as dose-selection and clinical study design, can be optimized with a strong understanding of the underlying pharmacokinetics of an agent. In this way, pharmacokinetics forms the bedrock of a pharmacometric...

Impact of Truncated Area on Point Estimate and Intra-Subject Variability in Bioequivalence of Dutasteride with Long Half-Life.

Purpose To investigate the effect of using truncated area under the curve (AUC0-72) on bioequivalence of dutasteride with long half-life in point estimate and intra-subject variability. Methods Fifteen subjects were enrolled in this single-dose, open-label, randomized two-way crossover design following an overnight fasting with five-week washout period. Plasma samples were collected to 72 h and ...

Prioritizing and optimizing sustainable measures for food waste prevention and management.

Food waste has gained prominence in the European political debate thanks to the recent Circular Economy package. Currently the waste hierarchy, introduced by the Waste Framework Directive, has been the rule followed to prioritize food waste prevention and management measures according to the environmental criteria. But when considering other criteria along with the environmental one, such as the e...

Ruxolitinib-conjugated gold nanoparticles for topical administration: An alternative for treating alopecia?

Alopecia is a dermatological condition for which Janus kinase (JAK) inhibitors have recently emerged as potential therapy options, but with limited practical use because of the systemic side effects. The topical use of Ruxolitinib in alopecia universalis has been demonstrated, but little is known about the pharmacodynamics and pharmacokinetics of this way of administration. Nanomedicine provides i...

Enhanced antibacterial effects of green synthesized ZnO NPs using Aristolochia indica against Multi-drug resistant bacterial pathogens from Diabetic Foot Ulcer.

Increased incidence of Multi-drug resistance in microorganisms has become the greatest challenge in the treatment of Diabetic Foot Ulcer (DFU) and urges the need of a new antimicrobial agent. In this study, we determined the bactericidal effects of ZnO nanoparticles (ZnO NPs) green synthesized from Aristolochia indica against Multi-drug Resistant Organisms (MDROs) isolated from pus samples of DFU ...

Changes in Student-Athletes' Self-Efficacy for Making Healthful Food Choices and Food Preparation Following a Cooking Education Intervention.

Are food and drink retailers within NHS venues adhering to NICE Quality standard 94 guidance on childhood obesity? A cross-sectional study of two large secondary care NHS hospitals in England.

To assess whether the food and drink retail outlets in two major National Health Service (NHS) district general hospitals in England adhere to quality statements 1-3 of the UK National Institute for Health and Care Excellence (NICE) quality standard 94.

ESTIMATION OF CIRCULATING DRUG METABOLITE EXPOSURE IN HUMAN USING IN VITRO DATA AND PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELLING: EXAMPLE OF A HIGH METABOLITE/PARENT DRUG RATIO.

TBPT ((R)-4-((4-(((4-((tetrahydrofuran-3-yl)oxy)benzo[d]isoxazol-3-yl)oxy)methyl)piperidin-1-yl)methyl)tetrahydro-2H-pyran-4-ol), a serotonin-4 receptor partial agonist, is metabolized to two metabolites: an N-dealkylation product (M1) and a cyclized oxazolidine structure (M2). After administration to humans, the exposure to M1 was low and the exposure to M2 was high, relative to the parent drug, ...

Influence of Enzalutamide on Cabazitaxel Pharmacokinetics; a Drug-Drug Interaction Study in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients.

In ongoing clinical research on metastatic castration-resistant prostate cancer (mCRPC) treatment, the potential enhanced efficacy of the combination of taxanes with AR-targeted agents, i.e. enzalutamide and abiraterone, is currently being explored. Since enzalutamide induces the CYP3A4 enzyme and taxanes are metabolized by this enzyme, a potential drug-drug interaction needs to be investigated.

Repurposing of the anti-malaria drug chloroquine for Zika Virus treatment and prophylaxis.

One of the major challenges of the current Zika virus (ZIKV) epidemic is to prevent congenital foetal abnormalities, including microcephaly, following ZIKV infection of pregnant women. Given the urgent need for ZIKV prophylaxis and treatment, repurposing of approved drugs appears to be a viable and immediate solution. We demonstrate that the common anti-malaria drug chloroquine (CQ) extends the li...

β-Eudesmol, an oxygenized sesquiterpene, stimulates appetite via TRPA1 and the autonomic nervous system.

Transient receptor potential ankyrin 1 (TRPA1) is a calcium-permeable non-selective cation channel, which is activated by various noxious or irritant substances in nature. TRPA1 activators have been generally recognized as noxious, however, foods and beverages containing TRPA1 activators are preferably consumed; the reasons for this discrepancy are not well understood. We demonstrate that TRPA1 is...

Evaluation of immune-mediated idiosyncratic drug toxicity using chimeric HLA transgenic mice.

Immune-mediated idiosyncratic drug toxicity (IDT) is a rare adverse drug reaction, potentially resulting in death. Although genome-wide association studies suggest that the occurrence of immune-mediated IDT is strongly associated with specific human leukocyte antigen (HLA) allotypes, these associations have not yet been prospectively demonstrated. In this study, we focused on HLA-B*57:01 and abaca...

Serum thymus and activation-regulated chemokine (TARC) is associated with the severity of drug reaction with eosinophilia and systemic symptoms/drug-induced hypersensitivity syndrome (DRESS/DIHS).

Drug reaction with eosinophilia and systemic symptoms/drug-induced hypersensitivity syndrome (DRESS/DIHS) is a severe adverse drug-induced reaction with reactivation of human herpesvirus 6 (HHV-6).(1-3) We previously reported that serum thymus and activation-regulated chemokine (TARC) levels were markedly increased in patients with DIHS and suggested TARC as a useful diagnostic marker of DIHS in t...

Genotoxicity of 11 heavy metals detected as food contaminants in two human cell lines.

Heavy metals, such as arsenic (As), antimony (Sb), barium (Ba), cadmium (Cd), cobalt (Co), germanium (Ge), lead (Pb), nickel (Ni), tellurium (Te), and vanadium (V) are widely distributed in the environment and in the food chain. Human exposure to heavy metals through water and food has been reported by different international agencies. Although some of these heavy metals are essential elements for...

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