A Model-Informed Drug Development Approach Supporting the Approval of an Unstudied Valbenazine Dose for Patients With Tardive Dyskinesia.

Valbenazine is a highly potent and selective inhibitor of synaptic vesicular monoamine transporter 2. The current therapeutic doses of valbenazine for tardive dyskinesia (TD) are 40, 60, or 80 mg capsules, given orally, once daily (QD). While 40 and 80 mg were investigated in phase 3 KINECT 3 trial and initially approved, the approval of valbenazine 60 mg was based on the analysis utilizing the Model-informed drug development (MIDD) approach, facilitated through the US Food and Drug Administration's MIDD Pilot Program.

A quantitative systems pharmacology model of plasma kallikrein-kinin system dysregulation in hereditary angioedema.

Hereditary angioedema (HAE) due to C1-inhibitor deficiency is a rare, debilitating, genetic disorder characterized by recurrent, unpredictable, attacks of edema. The clinical symptoms of HAE arise from excess bradykinin generation due to dysregulation of the plasma kallikrein-kinin system (KKS). A quantitative systems pharmacology (QSP) model that mechanistically describes the KKS and its role in HAE pathophysiology was developed based on HAE attacks being triggered by autoactivation of factor XII (FXII) to activated FXII (FXIIa), resulting in kallikrein production from prekallikrein.

Perception of learners on the effectiveness and suitability of MyDispense: a virtual pharmacy simulation and its integration in the clinical pharmacy module in Viet Nam.

Background: My Dispense is a virtual pharmacy simulation developed for students to train and practice dispensing skills in a safe environment that causes no harm to patients. This study was aimed to investigate learners' perspectives on the effectiveness of MyDispense and its suitability to integrate into the clinical pharmacy module in Viet Nam.

Methods: A mixed method approach was undertaken.

A time-calibrated mitogenomic phylogeny suggests that Korean is a bridge between Chinese and Japanese ..

The cicada species, and . (Hemiptera: Cicadidae), share numerous morphological characters, and their status as distinct species remains controversial. We reconstructed a phylogeny based on two new mitogenomes of .

Early clinical and economic outcomes of expanded criteria living kidney donors in the United States.

Background: The donation of what might be termed expanded criteria kidneys has become an increasingly common practice. This study aimed to assign expanded criteria and non-expanded criteria donation status and examine early clinical and economic outcomes among expanded criteria and non-expanded criteria living kidney donor (LKD) hospitalizations in the US.

Methods: Healthcare cost and Utilization Project-National (Nationwide) Inpatient Sample (HCUP-NIS) data (Jan 2008-Dec 2019, N = 12,020) were used.

A survey of parabens in aquatic environments in Hanoi, Vietnam and its implications for human exposure and ecological risk.

Seven parabens including methylparaben (MeP), ethylparaben (EtP), propylparaben (PrP), iso-propylparaben (iPrP), butylparaben (BuP), benzylparaben (BzP), and heptylparaben (HepP) were determined in bottled water, tap water, river water, lake water, and wastewater samples collected from Hanoi, Vietnam, using solid phase extraction (SPE) followed by ultrahigh performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). The highest total concentration of parabens were measured in wastewater (range, 27.3-1050 ng/L; mean/median, 268/175 ng/L), followed by lake water (range, 18.

A Combination of Chromatography with Tandem Mass Spectrometry Systems (UPLC-MS/MS and GC-MS/MS), Modified QuEChERS Extraction and Mixed-Mode SPE Clean-Up Method for the Analysis of 656 Pesticide Residues in Rice.

The emerging ungovernable application of pesticides in rice farming has attracted public concerns as these hazardous chemicals leave long-lasting environmental impacts and cause severe health effects. Here, an optimized analytical method was proposed for the measurement of 656 pesticide residues in rice samples collected in Vietnam. We utilized chromatography with tandem mass spectrometry systems (UPLC-MS/MS and GC-MS/MS) combined with a modified quick, easy, cheap, effective, rugged, and safe (QuEChERS) extraction method and adopted a mixed-mode SPE clean-up method for the analysis.

Transcriptome Analysis Reveals Potential Thermal Adaptation Mechanisms in the Cicada .

In metropolitan Seoul, populations of the cicada in hotter urban heat islands ("high UHIs") exhibit higher thermal tolerance than those in cooler UHIs ("low UHIs"). We hypothesized that heat stress may activate the expression of genes that facilitate greater thermal tolerance in high-UHI cicadas than in those from cooler areas. Differences in the transcriptomes of adult female cicadas from high-UHI, low-UHI, and suburban areas were analyzed at the unheated level, after acute heat stress, and after heat torpor.

Experimental data supporting adaptive locomotor responses to salt stress in the mud-tidal gastropod populations ().

This article describes the experimental locomotor data used to study the general and adaptive responses to salt stress of the northern Pacific intertidal gastropod . The data were obtained from a series of 30-day experiments on snails acclimated to different salinity regimes. Snails were collected from coastal areas on the eastern and western sides of the North Pacific Ocean.

Development of a core outcome set for clinical trials aimed at improving antimicrobial stewardship in care homes.

Background: Diverse outcomes reported in clinical trials of antimicrobial stewardship (AMS) interventions in care homes have hindered evidence synthesis. Our main objective was to develop a core outcome set (COS) for use in trials aimed at improving AMS in care homes.

Methods: A refined inventory of outcomes for AMS interventions in care homes, compiled from a previous study, was rated in a three-round international Delphi survey with 82 participants, using a nine-point Likert scale (from 1, unimportant, to 9, critical).

Multi-drug resistance in Streptococcus pneumoniae among children in rural Vietnam more than doubled from 1999 to 2014.

Aim: This study assessed the Streptococcus pneumoniae colonisation rate and susceptibility to antibiotics among preschool children in rural Vietnam.

Method: Nasopharyngeal samples were collected from 546 preschool children aged 6-59 months living in 460 households in the rural BaVi District of Hanoi and their main caregivers completed questionnaires. The samples were cultured, and the Streptococcus pneumoniae colonisation rate and antibiotic susceptibility were investigated.

Locomotor responses to salt stress in native and invasive mud-tidal gastropod populations ().

Plasticity in salt tolerance can be crucial for successful biological invasions of novel habitats by marine gastropods. The intertidal snail , which is native to East Asia but invaded the western shores of North America from Japan 80 years ago, provides an opportunity to examine how environmental salinity may shape behavioral and morphological traits. In this study, we compared the movement distance of four populations from native (Korea and Japan) and introduced (United States) habitats under various salinity levels (13, 23, 33, and 43 PSU) during 30 days of exposure in the lab.

Quantitative Systems Pharmacology Approaches for Immuno-Oncology: Adding Virtual Patients to the Development Paradigm.

Drug development in oncology commonly exploits the tools of molecular biology to gain therapeutic benefit through reprograming of cellular responses. In immuno-oncology (IO) the aim is to direct the patient's own immune system to fight cancer. After remarkable successes of antibodies targeting PD1/PD-L1 and CTLA4 receptors in targeted patient populations, the focus of further development has shifted toward combination therapies.

Leveraging Quantitative Systems Pharmacology Approach into Development of Human Recombinant Follistatin Fusion Protein for Duchenne Muscular Dystrophy.

Quantitative understanding about the dynamics of drug-target interactions in biological systems is essential, especially in rare disease programs with small patient populations. Follistatin, by antagonism of myostatin and activin, which are negative regulators of skeletal muscle and inflammatory response, is a promising therapeutic target for Duchenne Muscular Dystrophy. In this study, we constructed a quantitative systems pharmacology model for FS-EEE-Fc, a follistatin recombinant protein to investigate its efficacy from dual target binding, and, subsequently, to project its human efficacious dose.

Large-Scale Hybridisation as an Extinction Threat to the Suweon Treefrog (Hylidae: ).

Amphibians are in the midst of a sixth mass extinction, and human activities play a major role in pushing species towards extinction. Landscape anthropisation has impacts that indirectly threaten species, in addition to the obvious destruction of natural habitats. For instance, land modification may bring human-commensal species in contact with sister-clades from which they were previously isolated.

Not all cicadas increase thermal tolerance in response to a temperature gradient in metropolitan Seoul.

Rapid anthropogenic alterations caused by urbanization are increasing temperatures in urban cores, a phenomenon known as the urban heat island (UHI) effect. Two cicada species, Cryptotympana atrata and Hyalessa fuscata (Hemiptera: Cicadidae), are abundant in metropolitan Seoul where their population densities correlate strongly with UHI intensities. Such a positive correlation between cicada density and UHI intensity may be possible if cicada abundance is linked to a certain thermal tolerance.

Trends and impact of antimicrobial resistance on older inpatients with urinary tract infections (UTIs): A national retrospective observational study.

Urinary tract infections (UTIs) are one of the most common infections in older people and are associated with increased morbidity and mortality. UTIs are also associated with increased risk of antimicrobial resistance (AR). This study examined changes in AR among older inpatients with a primary diagnosis of UTIs in the United States over an 8-year period and the impact of AR on clinical outcomes and hospital costs.

Correction to: Characterization of polymorphic loci for two cicada species: Cryptotympana atrata and Hyalessa fuscata (Hemiptera: Cicadidae).

Unfortunately the title of the original publication contains a typo. Instead of (Hemiptera: Cicadoidae) it should be (Hemiptera: Cicadidae).

Interventions to Improve Antimicrobial Stewardship for Older People in Care Homes: A Systematic Review.

Background: Inappropriate antimicrobial prescribing has been reported in care homes. This may result in serious drug-related adverse events, Clostridium difficile colonization, and the development of antimicrobial resistance among care home residents. Interventions to improve antibiotic prescribing in nursing homes have been reported through clinical trials, but whether antifungal and antiviral prescribing and residential homes have been considered, or how outcomes were measured and reported in such interventions, remains unclear.

Characterization of polymorphic loci for two cicada species: Cryptotympana atrata and Hyalessa fuscata (Hemiptera: Cicadoidae).

The cicada species Cryptotympana atrata and Hyalessa fuscata are abundant in metropolitan Seoul where their population densities are positively correlated with local urban heat island intensities. Here, we characterized two panels of polymorphic markers for both species. A set of 21 microsatellite markers previously developed for a Chinese population of C.

Pharmacist-Led Intervention to Enhance Medication Adherence in Patients With Acute Coronary Syndrome in Vietnam: A Randomized Controlled Trial.

Patient adherence to cardioprotective medications improves outcomes of acute coronary syndrome (ACS), but few adherence-enhancing interventions have been tested in low-income and middle-income countries. We aimed to assess whether a pharmacist-led intervention enhances medication adherence in patients with ACS and reduces mortality and hospital readmission. We conducted a randomized controlled trial in Vietnam.

Urban heat island effect on cicada densities in metropolitan Seoul.

Background: Urban heat island (UHI) effect, the ubiquitous consequence of urbanization, is considered to play a major role in population expansion of numerous insects. and are the most abundant cicada species in the Korean Peninsula, where their population densities are higher in urban than in rural areas. We predicted a positive relationship between the UHI intensities and population densities of these two cicada species in metropolitan Seoul.

Enhancing prescribing of guideline-recommended medications for ischaemic heart diseases: a systematic review and meta-analysis of interventions targeted at healthcare professionals.

Objectives: Ischaemic heart diseases (IHDs) are a leading cause of death worldwide. Although prescribing according to guidelines improves health outcomes, it remains suboptimal. We determined whether interventions targeted at healthcare professionals are effective to enhance prescribing and health outcomes in patients with IHDs.

Efficient isolation method for high-quality genomic DNA from cicada exuviae.

In recent years, animal ethics issues have led researchers to explore nondestructive methods to access materials for genetic studies. Cicada exuviae are among those materials because they are cast skins that individuals left after molt and are easily collected. In this study, we aim to identify the most efficient extraction method to obtain high quantity and quality of DNA from cicada exuviae.