Development and multicenter validation of an LC-MS-based bioanalytical method for antisense therapeutics.

Many bioanalytical methods for antisense oligonucleotides (ASOs) using LC-MS have been reported. However, no data have been available on the reproducibility and robustness of a single bioanalytical method for ASOs. As such, in the current study, we evaluated the reproducibility and robustness of LC-MS-based bioanalytical methods for ASOs in multiple laboratories.

Application of transparent microperforated panels to acrylic partitions for desktop use: A case study by prototyping.

There are various measures currently in place to prevent the spread of coronavirus (COVID-19); however, in some cases, these can have an adverse effect on the acoustic environment in buildings. For example, transparent acrylic partitions are often used in eating establishments, meeting rooms, offices, etc., to prevent droplet infection.

Basic considerations on the practical method for predicting sound insulation performance of a single-leaf window.

As a basic study of a practical method for predicting the sound insulation performance of windows, this report presents a study of the sound reduction index of windows with single glazing, below a critical frequency. First, the results calculated by an existing theory for a single plate for the sound reduction indices are compared with measured results of actual windows to assess the theory's applicability for evaluating the sound insulation performance of windows. Then, a regression analysis is employed to measure the results of a certain number of actual windows to explore a further development of a more practical prediction.

Bioanalysis of therapeutic monoclonal antibody by peptide adsorption-controlled LC-MS.

We aimed to develop an easy, low-cost and versatile mass spectrometric method for the bioanalysis of a therapeutic monoclonal antibody (mAb) in human serum that employs peptide adsorption-controlled (PAC)-LC/MS using selected reaction monitoring mode (LC-MS/MS-SRM). Rituximab was used as a model mAb. To apply the method to human serum samples, a peptide of the complementarity-determining region was selected as the surrogate peptide.

Some considerations on the use of space sound absorbers with next-generation materials reflecting COVID situations in Japan: additional sound absorption for post-pandemic challenges in indoor acoustic environments.

In this study, we first point out the possible acoustic problems associated with the post-pandemic operation of built environments. In particular, we focus on the problem of acoustic deficiency due to the lack of absorption. This deficiency, which is likely to be encountered in most enclosed spaces in a range of establishments, is due to the reduced number of audience members or users of the space as a result of social distancing.

Human plasma concentration-time profiles of troglitazone and troglitazone sulfate simulated by in vivo experiments with chimeric mice with humanized livers and semi-physiological pharmacokinetic modeling.

Troglitazone and its major metabolite troglitazone sulfate were intravenously administered to chimeric mice with different ratios of liver replacement by human hepatocytes. Total clearances were converted to hepatic intrinsic clearances normalized to their liver weight, with the assumption that extra-hepatic elimination of these compounds was negligible. These values were plotted against the replacement indices, and postulated values for virtual 100% chimeric mice were assumed to be equivalent to those in humans.

Generic MS-based method for the bioanalysis of therapeutic monoclonal antibodies in nonclinical studies.

A generic bioanalytical method was developed to quantify therapeutic IgG1 monoclonal antibodies (mAbs) in mouse sera by combining an easy sample preparation method with LC/MS using selected reaction monitoring. Rituximab and trastuzumab were used as model mAbs. A synthetic stable isotope-labeled peptide or a stable isotope-labeled mAb was used as an internal standard.

Establishment of the Global SEND Alliance (G-SEND) in Japan and efficient creation of electronic SEND datasets between CROs.

The Standard for Exchange of Nonclinical Data (SEND), adopted by the US Food and Drug Administration (FDA), is a set of regulations for digitalization and standardization of nonclinical study data; thus, related organizations have begun implementing processes in support of SEND. The Global Editorial and Steering Committee (GESC), which provides oversight of the International Harmonization of Nomenclature and Diagnostic Criteria (INHAND), has prepared the SEND Controlled Terminology (CT) for toxicologic pathology. SEND provides electronic data standards created by the Clinical Data Interchange Standards Consortium (CDISC), and CDISC also collaborates in the implementation of SEND.

Development of a novel RANKL-based peptide, microglial healing peptide1-AcN (MHP1-AcN), for treatment of ischemic stroke.

Although the regulation of post-ischemic inflammation is an important strategy to treat ischemic stroke, all clinical trials have failed to show its efficacy. To solve the problem, we previously developed a novel partial peptide of RANKL, microglial healing peptide 1 (MHP1), which could reduce ischemic injury by inhibiting Toll-like receptor (TLR) induced inflammation. However, optimization of the peptide was necessary to increase the stability and efficacies for clinical use.

Relationship between sound radiation from sound-induced and force-excited vibration: Analysis using an infinite elastic plate model.

Although sound radiation from sound-induced vibration and from force-excited vibration of solid structures are similar phenomena in terms of radiating from vibrating structures, the general relationship between them has not been explicitly studied to date. In particular, airborne sound transmission through walls and sound radiation from structurally vibrating surfaces in buildings are treated as different issues in architectural acoustics. In this paper, a fundamental relationship is elucidated through the use of a simple model.

Simulation of human plasma concentration-time profiles of the partial glucokinase activator PF-04937319 and its disproportionate N-demethylated metabolite using humanized chimeric mice and semi-physiological pharmacokinetic modeling.

1. The partial glucokinase activator N,N-dimethyl-5-((2-methyl-6-((5-methylpyrazin-2-yl)carbamoyl)benzofuran-4-yl)oxy)pyrimidine-2-carboxamide (PF-04937319) is biotransformed in humans to N-methyl-5-((2-methyl-6-((5-methylpyrazin-2-yl)carbamoyl)benzofuran-4-yl)oxy)pyrimidine-2-carboxamide (M1), accounting for ∼65% of total exposure at steady state. 2.

Distinct effects of moisture and air contents on acoustic properties of sandy soil.

Knowledge of distinct effects of moisture content and air volume on acoustic properties of soil is sought to predict the influence of human activities such as cultivation on acoustic propagation outdoors. This work used an impedance tube with the two-thickness method to investigate such effects. For a constant moisture weight percentage, the magnitude of the characteristic impedance became smaller and the absorption coefficient became higher with increase of the air space ratio.

Application of modified integration rule to time-domain finite-element acoustic simulation of rooms.

The applicability of the modified integration rule for time-domain finite-element analysis is tested in sound field analysis of rooms involving rectangular elements, distorted elements, and finite impedance boundary conditions. Dispersion error analysis in three dimensions is conducted to evaluate the dispersion error in time-domain finite-element analysis using eight-node hexahedral elements. The results of analysis confirmed that fourth-order accuracy with respect to dispersion error is obtainable using the Fox-Goodwin method (FG) with a modified integration rule, even for rectangular elements.