scholarly journals Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment

AAPS Open ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Mark Alasandro ◽  
Dilip Choudhury ◽  
Kim Huynh-Ba ◽  
Jianmei Kochling ◽  
Christopher Latoz ◽  
...  
Keyword(s):  
Vaccine Development ◽  
Rapid Development ◽  
Regulatory Agencies ◽  
Meeting Report ◽  
Vaccine Type ◽  
Health Care Leaders ◽  
Vaccine Stability ◽  
The Stability ◽  
Vaccine Distribution

AbstractThe Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on “Vaccine Stability Considerations to Enable Rapid Development and Deployment”, on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the industry, academia, regulatory agencies, as well as health care leaders. This paper presents a review of the topics covered. Specifically the challenges in accelerating vaccine development and analytical characterization techniques to establish shelf-life were covered. Additionally, vaccine stability modeling using prior knowledge stability models and advanced kinetic analysis played a key in the EUA approaches discussed during the workshop. Finally, the role of stability studies in addressing the challenges of vaccine distribution and deployment during the pandemic were a focus of presentations and panel discussions.Although the workshop did not have any presentation topics directly dedicated to the mRNA vaccines, the techniques discussed are generally applicable. The mRNA vaccine developers were represented in the panel discussions, where experts involved in the EUA approval/deployment stages for this vaccine type could discuss the challenges as applied to their vaccines.

scholarly journals PLACE OF CUSTOMS PAYMENTS IN THE COUNTRY'S BUDGET

2020 ◽  
pp. 319-324
Author(s):  
T.M. Asanaliev ◽  
K. Stalbek uulu ◽  
A.K. Toktalieva
Keyword(s):  
Foreign Trade ◽  
Rapid Development ◽  
Agricultural Products ◽  
Kyrgyz Republic ◽  
Foreign Countries ◽  
Import And Export ◽  
The Government ◽  
The Stability ◽  
Favorable Conditions

In a market economy, the role of customs payments is great and their functions are diverse. These functions are closely related to the country's economy. To fulfill the fiscal function, the customs authorities transfer to the budget an amount that is approximately 30-35% of the total income of our state, more precisely, it goes to the budget with over 42 billion soms per year. Also, in order to protect domestic producers, the domestic market and preserve the stability of the country, the Government of the Kyrgyz Republic issues appropriate decrees aimed at regulating the import and export of goods by increasing or decreasing the rates of import customs duties. This is the protectionist function of customs payments. Examples are the introduction of regulations on imported sugar products, the introduction of customs duties on agricultural products - corn, barley. The accession of the Kyrgyz Republic to the WTO in 1998 created favorable conditions for the rapid development of foreign trade. On this basis, the number of agreements concluded by foreign trade entrepreneurs of the Kyrgyz Republic with foreign partners is growing every year. This, of course, will strengthen the Kyrgyz Republic's ties with foreign countries and strengthen the unity of the two peoples.

scholarly journals The Key Role of the Financial Regulation in FinTech Ecosystem: A Model Validation

2021 ◽  
Vol 39 (12) ◽  
Author(s):  
Mohammad Fahmi Arkanuddin ◽  
Ferdinand D. Saragih ◽  
Bernardus Yuliarto Nugroho
Keyword(s):  
Credit Risk ◽  
Consumer Protection ◽  
Financial Regulation ◽  
Financial Institution ◽  
Rapid Development ◽  
Big Data Analytics ◽  
Disruptive Innovation ◽  
Protection Agency ◽  
The Stability

The objective of this research is for describing the key role of financial (FinTech) regulation to manage the risks, keep-up the balance and stability of FinTech ecosystem from the highest impact of risks’ in this industry. FinTech lending has grown rapidly in recent years in many countries and becomes a promising business model in the future, because it is a disruptive innovation to today's financial and banking markets. The rapid development of FinTech lending due to the use of internet-based mobile application platforms, so that it is easily accessible by anyone and anywhere, it encourages an increase in lending to the customers, however credit risk (although absorbed by lenders or investors, still indirectly affects the platform operators), experienced an increase due to non performing loan or NPL. The increase in NPL is an important concern for FinTech lending industry stakeholders, and if it is not addressed it will disrupt the FinTech ecosystem, let alone cause systemic risk, it will be the toughest disturbance in the stability of the FinTech ecosystem, considering that the risk of FinTech lending has a significant influence on the FinTech ecosystem, so that if the level of risk increases, it affects the FinTech ecosystem, this condition requires the key role of financial (FinTech) regulation that can mitigate risk, because financial (FinTech) regulation has a very strong correlation or relationship, so that it can mitigate the risks faced. Another key role of financial (FinTech) regulation is to strengthen the FinTech ecosystem, with new elements needed by the industry and encourage the industry to develop the concept of ecosystem-based risk management in this industry, because it is believed that this concept can mitigate risk as well. Fundamental risks in the FinTech lending industry include: (i) credit risk, (ii) operational risk and (iii) liquidity risk, meanwhile pandemic risk is a new element that is also being investigated, the results of the study show that pandemic risk has a positive correlation with start-up FinTech companies, this means that a pandemic still allows this industry to develop and grow. Financial (FinTech) regulation as a key role is supported by 2 (two) main rules, namely (i) regulatory and (ii) supervisory and 2 (two) complementary provisions to strengthen regulations related to IT process support, namely big data analytics, automation & robotics and FinTech consumer protection agency. The FinTech ecosystem also needs to be strengthened, with new elements needed to exist, such as credit insurance institutions that stand alone and are separated from traditional financial institution element and FinTech consumer protection agency.

A Statistical Study of Process Variables to Optimize a High Speed Curtain Coater: Part I

TAPPI Journal ◽  
2009 ◽  
Vol 8 (1) ◽  
pp. 20-26 ◽  
Author(s):  
PEEYUSH TRIPATHI ◽  
MARGARET JOYCE ◽  
PAUL D. FLEMING ◽  
MASAHIRO SUGIHARA
Keyword(s):  
Boundary Layer ◽  
Experimental Design ◽  
High Speed ◽  
Statistical Study ◽  
Process Variables ◽  
High Speeds ◽  
The Stability ◽  
Air Removal ◽  
Removal System

Using an experimental design approach, researchers altered process parameters and material prop-erties to stabilize the curtain of a pilot curtain coater at high speeds. Part I of this paper identifies the four significant variables that influence curtain stability. The boundary layer air removal system was critical to the stability of the curtain and base sheet roughness was found to be very important. A shear thinning coating rheology and higher curtain heights improved the curtain stability at high speeds. The sizing of the base sheet affected coverage and cur-tain stability because of its effect on base sheet wettability. The role of surfactant was inconclusive. Part II of this paper will report on further optimization of curtain stability with these four variables using a D-optimal partial-facto-rial design.

The Role of Hydrophobicity in the Stability and pH-Switchability of (RXDX)4 and Coumarin-RXDX Conjugate β-Sheets

2020 ◽  
Author(s):  
Ryan Weber ◽  
Martin McCullagh
Keyword(s):  
Biological Imaging ◽  
Ph Sensing ◽  
Hydrophobic Residue ◽  
Ideal Candidate ◽  
Self Assembling ◽  
Sensing Applications ◽  
Β Sheets ◽  
The Stability ◽  
Dynamics Simulations

<p>pH-switchable, self-assembling materials are of interest in biological imaging and sensing applications. Here we propose that combining the pH-switchability of RXDX (X=Ala, Val, Leu, Ile, Phe) peptides and the optical properties of coumarin creates an ideal candidate for these materials. This suggestion is tested with a thorough set of all-atom molecular dynamics simulations. We first investigate the dependence of pH-switchabiliy on the identity of the hydrophobic residue, X, in the bare (RXDX)<sub>4</sub> systems. Increasing the hydrophobicity stabilizes the fiber which, in turn, reduces the pH-switchabilty of the system. This behavior is found to be somewhat transferable to systems in which a single hydrophobic residue is replaced with a coumarin containing amino acid. In this case, conjugates with X=Ala are found to be unstable and both pHs while conjugates with X=Val, Leu, Ile and Phe are found to form stable β-sheets at least at neutral pH. The (RFDF)<sub>4</sub>-coumarin conjugate is found to have the largest relative entropy value of 0.884 +/- 0.001 between neutral and acidic coumarin ordering distributions. Thus, we posit that coumarin-(RFDF)<sub>4</sub> containing peptide sequences are ideal candidates for pH-sensing bioelectronic materials.</p>

Metal-Metal Cooperative Bond Activation by Heterobimetallic Alkyl, Aryl, and Acetylide PtII/CuI Complexes

2020 ◽  
Author(s):  
Shubham Deolka ◽  
Orestes Rivada Wheelaghan ◽  
Sandra Aristizábal ◽  
Robert Fayzullin ◽  
Shrinwantu Pal ◽  
...  
Keyword(s):  
Alkyl Group ◽  
Bond Activation ◽  
Bond Cleavage ◽  
Terminal Alkyne ◽  
Alkyl Aryl ◽  
Metal Metal ◽  
The Stability ◽  
Selective Formation ◽  
Organoplatinum Compounds

We report selective formation of heterobimetallic PtII/CuI complexes that demonstrate how facile bond activation processes can be achieved by altering reactivity of common organoplatinum compounds through their interaction with another metal center. The interaction of the Cu center with Pt center and with a Pt-bound alkyl group increases the stability of PtMe2 towards undesired rollover cyclometalation. The presence of the CuI center also enables facile transmetalation from electron-deficient tetraarylborate [B(ArF)4]- anion and mild C-H bond cleavage of a terminal alkyne, which was not observed in the absence of an electrophilic Cu center. The DFT study indicates that the role of Cu center acts as a binding site for alkyne substrate, while activating its terminal C-H bond.

LANDSLIDE RISK MANAGEMENT IN THE COASTAL ZONE OF THE KUIBYSHEV RESERVOIR DUE THE DESIGN OF HIGH-SPEED LINE "MOSCOW-KAZAN"

2017 ◽  
Author(s):  
Nikolai Petrov ◽  
Nikolai Petrov ◽  
Inna Nikonorova ◽  
Inna Nikonorova ◽  
Vladimir Mashin ◽  
...  
Keyword(s):  
High Speed ◽  
Computational Models ◽  
Stable State ◽  
Landslide Risk ◽  
Kuibyshev Reservoir ◽  
Stepped Surface ◽  
The Stability ◽  
Landslide Slope ◽  
The Village

High-speed railway "Moscow-Kazan" by the draft crosses the Volga (Kuibyshev reservoir) in Chuvashia region 500 m below the village of New Kushnikovo. The crossing plot is a right-bank landslide slope with a stepped surface. Its height is 80 m; the slope steepness -15-16o. The authors should assess the risk of landslides and recommend anti-landslide measures to ensure the safety of the future bridge. For this landslide factors have been analyzed, slope stability assessment has been performed and recommendations have been suggested. The role of the following factors have been analyzed: 1) hydrologic - erosion and abrasion reservoir and runoff role; 2) lithologyc (the presence of Urzhum and Northern Dvina horizons of plastically deformable rocks, displacement areas); 3) hydrogeological (the role of perched, ground and interstratal water); 4) geomorphological (presence of the elemental composition of sliding systems and their structure in the relief); 5) exogeodynamic (cycles and stages of landslide systems development, mechanisms and relationship between landslide tiers of different generations and blocks contained in tiers). As a result 6-7 computational models at each of the three engineering-geological sections were made. The stability was evaluated by the method “of the leaning slope”. It is proved that the slope is in a very stable state and requires the following measures: 1) unloading (truncation) of active heads blocks of landslide tiers) and the edge of the plateau, 2) regulation of the surface and groundwater flow, 3) concrete dam, if necessary.

Short-Term Ultramicronized Palmitoylethanolamide Therapy in Patients with Myasthenia Gravis: a Pilot Study to Possible Future Implications of Treatment

2019 ◽  
Vol 18 (3) ◽  
pp. 232-238 ◽  
Author(s):  
Emanuela Onesti ◽  
Vittorio Frasca ◽  
Marco Ceccanti ◽  
Giorgio Tartaglia ◽  
Maria Cristina Gori ◽  
...  
Keyword(s):  
Pilot Study ◽  
Myasthenia Gravis ◽  
Repetitive Nerve Stimulation ◽  
Beneficial Effects ◽  
Antibody Titers ◽  
The Stability ◽  
Ultramicronized Palmitoylethanolamide ◽  
Open Pilot

Background: The cannabinoid system may be involved in the humoral mechanisms at the neuromuscular junction. Ultramicronized-palmitoylethanolamide (μm-PEA) has recently been shown to reduce the desensitization of Acetylcholine (ACh)-evoked currents in denervated patients modifying the stability of ACh receptor (AChR) function. <p> Objective: To analyze the possible beneficial effects of μm-PEA in patients with myasthenia gravis (MG) on muscular fatigue and neurophysiological changes. <p> Method: The duration of this open pilot study, which included an intra-individual control, was three weeks. Each patient was assigned to a 1-week treatment period with μm-PEA 600 mg twice a day. A neurophysiological examination based on repetitive nerve stimulation (RNS) of the masseteric and the axillary nerves was performed, and the quantitative MG (QMG) score was calculated in 22 MG patients every week in a three-week follow-up period. AChR antibody titer was investigated to analyze a possible immunomodulatory effect of PEA in MG patients. <p> Results: PEA had a significant effect on the QMG score (p=0.03418) and on RNS of the masseteric nerve (p=0.01763), thus indicating that PEA reduces the level of disability and decremental muscle response. Antibody titers did not change significantly after treatment. <p> Conclusion: According to our observations, μm-PEA as an add-on therapy could improve muscular response to fatigue in MG. The possible modulation of AChR currents as a means of eliciting a direct effect from PEA on the conformation of ACh receptors should be investigated. The co-role of cytokines also warrants an analysis. Given the rapidity and reversibility of the response, we suppose that PEA acts directly on AChR, though further studies are needed to confirm this hypothesis.

Dynamic Performance of High-Speed Electric Multiple Unit within Multi-Body System Simulation

2019 ◽  
Vol 12 (4) ◽  
pp. 339-349
Author(s):  
Junguo Wang ◽  
Daoping Gong ◽  
Rui Sun ◽  
Yongxiang Zhao
Keyword(s):  
High Speed ◽  
Rapid Development ◽  
Dynamic Performance ◽  
Body System ◽  
High Speed Railway ◽  
Evaluation Indexes ◽  
Actual Operation ◽  
Multiple Unit ◽  
The Stability ◽  
Multi Body

Background: With the rapid development of the high-speed railway, the dynamic performance such as running stability and safety of the high-speed train is increasingly important. This paper focuses on the dynamic performance of high-speed Electric Multiple Unit (EMU), especially the dynamic characteristics of the bogie frame and car body. Various patents have been discussed in this article. Objective: To develop the Multi-Body System (MBS) model of EMU, verify whether the dynamic performance meets the actual operation requirements, and provide some useful information for dynamics and structural design of the proposed EMU. Methods: According to the technical characteristics of a typical EMU, a MBS model is established via SIMPACK, and the measured data of China high-speed railway is taken as the excitation of track random irregularity. To test the dynamic performance of the EMU, including the stability and safety, some evaluation indexes such as wheel-axle lateral forces, wheel-axle lateral vertical forces, derailment coefficients and wheel unloading rates are also calculated and analyzed in detail. Results: The MBS model of EMU has better dynamic performance especially curving performance, and some evaluation indexes of the stability and safety have also reached China’s high-speed railway standards. Conclusion: The effectiveness of the proposed MBS model is verified, and the dynamic performance of the MBS model can meet the design requirements of high-speed EMU.

On the Structure of Lead(II) Complexes in Aqueous Solutions. I. Trinuclear Clusters

1995 ◽  
Vol 60 (4) ◽  
pp. 527-536 ◽  
Author(s):  
Martin Breza ◽  
Alena Manová
Keyword(s):  
Quantum Chemistry ◽  
Aqueous Solutions ◽  
Electronic Structures ◽  
Mndo Method ◽  
Model Systems ◽  
Trinuclear Clusters ◽  
The Stability ◽  
Semiempirical Mndo

Using semiempirical MNDO method of quantum chemistry the optimal geometries and corresponding electronic structures of [Pb3(OH)n]6-n model systems as well as of their hydrated [Pb3(OH)n(H2O)8-n]6-n analogues (n = 4, 5) are investigated. The most stable trinuclear lead(II) complexes present in aqueous solutions correspond to cyclo-(μ3-OH)(μ2-OH)3Pb32+, Pb(μ-OH)2Pb(μ-OH)2Pb2+, cyclo-(μ3-OH)2(μ2-OH)3Pb3+, Pb(OH)(μ-OH)2Pb(μ-OH)Pb(OH)+ and Pb(OH)(μ-OH)2Pb(μ-OH)2Pb+ systems. The key role of OH bridges (by vanishing direct Pb-Pb bonds) on the stability of individual isomers is discussed.

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