Search

In this paper, I focus on Edmund Husserl's analyses of the act of approval and the role he attributes to it in his ethics. I show that we can deepen our understanding of both if we rely on his critical reflections on Shaftesbury's theory of affections in his lecture course Einleitung in die Ethik. The sections of this course devoted to Shaftesbury are the only place in Husserl's later philosophical production where he addresses the need to clarify the nature of approval from a phenomenological point of view and provides precise indications about the role that such emotions play in our life. I thereby examine Husserl's criticisms of Shaftesbury's account of reflective emotions, and I compare these criticisms with Husserl's account of approval in the texts from the Konvolut über Billigung collected in the Studien zur Struktur des Bewusstseins. I argue that, according to Husserl, approval is an essential but not sufficient component in the pursuit of virtue. The upshot is that crucial parts of Husserl's ethics come from a radical and original reworking of central notions of the early modern sentimentalist tradition. [ABSTRACT FROM AUTHOR]

Background: Spinal implant failure is associated with prolonged patient suffering, high costs for the medical device industry, and a high economic burden for the health care system. Pre‐clinical mechanical testing has great potential to reduce the risk of such failure. However, there are no binding regulations for planning and interpretation of mechanical testing. Therefore, different strategies exist. Mainly for novel implants an option is to start with a structured scientific literature search that forms an objective background for the definition of an implant‐specific test plan, the derivation of acceptance criteria and interpretation of the test results. Methods: This paper describes, how a literature‐based approach can look like from the initial literature search through the derivation of the test plan and the acceptance criteria, to the final test result evaluation and how this approach can support the proof that the device meets all necessary safety and performance standards. Results: The main advantage of this literature‐based approach is that testing and test result interpretation are linked with the loads acting on the individual implant in vivo. In an ideal case, testing is focused on the individual implant in a way that ensures maximum efficiency during the development and approval process combined with maximum insight in safety and effectiveness of the implant. Even comparative implant testing may become obsolete, which is a big advantage if comparative implant and related data are not available. Conclusion: This approach to pre‐clinical mechanical testing offers the potential to create a chain of arguments, from literature review through testing to the interpretation of test results. This methodology can significantly enhance testing efficiency, reduce risk of failure, and ultimately prevent unnecessary patient suffering and healthcare costs. By synthesizing scientific insights with regulatory requirements, this review aims to guide clinicians and researchers in improving patient care and advancing device technologies. [ABSTRACT FROM AUTHOR]

Copyright of GeSec: Revista de Gestao e Secretariado is the property of Sindicato das Secretarias e Secretarios do Estado de Sao Paulo (SINSESP) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Vekâletsiz işgörme, kanundan doğan borç ilişkisi kaynaklarından birisidir. Vekâletsiz işgörmede, işgören akdi bir temele dayanmaksızın, yetkili veya yükümlü olmadan işsahibinin işini görmektedir. İşgören böyle bir işi işsahibinin yararına olacak şekilde görürse bu halde gerçek vekâletsiz işgörme söz konusu olurken, işgören işsahibine ait bir işi bencil amaçlarla kendi yararına görürse gerçek olmayan vekâletsiz işgörmeden bahsedilir. Gerçek olmayan vekâletsiz işgörmede, teknik anlamda bir işgörmeden dahi bahsedilememektedir. İşsahibi, akdi bir temele dayanmayan işgörmeyi sonradan uygun bulabilir. Uygun bulma sonucunda işgören ve işsahibi arasındaki hukuki ilişkiye, başlangıcından itibaren uygun düştüğü ölçüde vekâlet hükümleri uygulanır. Bunun yanında uygun bulmanın hangi vekâletsiz işgörme türlerine uygulanacağı tartışmalıdır. İsabetli olan yaklaşıma göre uygun bulma, ancak gerçek vekâletsiz işgörmede söz konusu olabilir.

Copyright of Neutrosophic Computing & Machine Learning is the property of Multimedia Larga and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

In examining public evaluations of governing institutions, are job approval and legitimacy related? This question has dominated scholarship on Supreme Court legitimacy for decades. Conventional wisdom suggests that specific support (e.g., job approval) and diffuse support (e.g., legitimacy) are independent. Specific support captures short-term orientations based on policy alignment with the Court. Legitimacy is a long-term perspective reflecting more fundamental support for the Court as a governing institution. We challenge the paradigm that job approval and legitimacy are largely unrelated concepts. Specifically, we employ a variety of statistical techniques and panel data to show that changes in legitimacy are a direct effect of changes in public approval. Salient decisions and Court vacancies directly shape approval and indirectly shape legitimacy through their effects on approval. Longitudinal analysis confirms that changes in job approval precede and predict changes in legitimacy. These results suggest that the Court needs public approval, and its public approval is rooted in outcome-oriented perceptions of its decisions and membership. Further, sustained low levels of approval will eventually erode legitimacy and limit the Court's influence over policy. Thus, like the outwardly political executive and legislative branches, it is important for the Court to build political capital through job approval. [ABSTRACT FROM AUTHOR]

Abstract Background Spinal implant failure is associated with prolonged patient suffering, high costs for the medical device industry, and a high economic burden for the health care system. Pre‐clinical mechanical testing has great potential to reduce the risk of such failure. However, there are no binding regulations for planning and interpretation of mechanical testing. Therefore, different strategies exist. Mainly for novel implants an option is to start with a structured scientific literature search that forms an objective background for the definition of an implant‐specific test plan, the derivation of acceptance criteria and interpretation of the test results. Methods This paper describes, how a literature‐based approach can look like from the initial literature search through the derivation of the test plan and the acceptance criteria, to the final test result evaluation and how this approach can support the proof that the device meets all necessary safety and performance standards. Results The main advantage of this literature‐based approach is that testing and test result interpretation are linked with the loads acting on the individual implant in vivo. In an ideal case, testing is focused on the individual implant in a way that ensures maximum efficiency during the development and approval process combined with maximum insight in safety and effectiveness of the implant. Even comparative implant testing may become obsolete, which is a big advantage if comparative implant and related data are not available. Conclusion This approach to pre‐clinical mechanical testing offers the potential to create a chain of arguments, from literature review through testing to the interpretation of test results. This methodology can significantly enhance testing efficiency, reduce risk of failure, and ultimately prevent unnecessary patient suffering and healthcare costs. By synthesizing scientific insights with regulatory requirements, this review aims to guide clinicians and researchers in improving patient care and advancing device technologies.

The idea of using nuclear weapons to kill noncombatants is said to evoke strong moral opprobrium among millions of individuals across the globe, such that national leaders should be constrained from using the weapons even when such a decision would be strategically sensible. Classical area scholarship and recent survey evidence suggest that this "nuclear taboo" is strong among the Chinese public, buttressed by culturally grounded preferences for moderation in warfare. Drawing on findings in cultural sociology and political behavior, we argue that previous studies mislead on the extent to which ordinary Chinese citizens might oppose the use of nuclear weapons in a real military clash, primarily due to a failure to distinguish baseline preferences for nuclear nonuse from the willingness to approve of governmental decisions to use these weapons. Results from an original survey experiment fielded in mainland China show that many individuals who personally dislike the idea of using nuclear weapons are nonetheless willing to support their leaders' decision to do so. Our study contributes new and systematic knowledge about Chinese nuclear attitudes and highlights the value of harnessing interdisciplinary insights to inform the research agenda on the nuclear taboo. [ABSTRACT FROM AUTHOR]

Simple Summary: Sarcomas are a group of rare heterogeneous neoplasms of mesenchymal origin. Despite attendant difficulties in study of such disease states, there has been at least one US Federal Drug Administration (FDA) treatment approval for sarcomas in 8 of the last 11 years since 2013. The relative costs, as well as trends in the marketplace, for medications approved for sarcoma have heretofore been unexplored. Given the expansion of medical treatments for sarcoma subtypes in the past decade, it is vital to assess the current status of the landscape to better comprehend achieved successes, challenges, and future directions. Herein, we provide an overview of some of the trends in FDA approvals as well as their associated costs and correlations with incidence as well as outcomes. Sarcomas represent a diverse set of both malignant and benign subtypes consisting of often rare and ultra-rare conditions. Over the course of the last decade, there have been numerous FDA approvals for agents treating various sarcoma subtypes. Given this burgeoning landscape of sarcoma treatments, we seek to review current FDA-approved agents with respect to their rates of incidence, approval rates, and financial costs. We gathered clinical trial data by searching FDA approval announcements from 2013 to 2023. We determined the 30 day and one year cost of therapy for patients of FDA-approved sarcoma treatments in the aforementioned timeframe. From 2013 to 2023, 14 medications have been FDA-approved for sarcoma subtypes. The 30-day dosing prices for these medications range from $11,162.86 to $46,926.00. Since 2013, the rates of approval for sarcoma medications have been higher than in prior decades. Nonetheless, there remains the potential for significant financial toxicity for patients living with sarcoma. [ABSTRACT FROM AUTHOR]

This research seeks to understand the truth of approval and consideration for Arabic taste and their impact on directing what contradicts the linguistic norms. This includes considerations for the logic of the language and its unique system, which is observed by its speakers and linked to their minds, represented in its practical usage. The study is divided into two parts. In the first, I discuss the concept of linguistic measurement, its relationship with both grammatical and morphological measurements, then its relationship with approval, and with linguistic taste. In the second part, I discuss the reasons for deviating from the norm that are related to considering the taste of the language and approval of the fluent speaker, such as: requesting lightness, considering verbal proportionality, frequent use, and considering the poet's taste within what is called: poetic necessity. The research concluded that the consideration for Arabic approval and linguistic taste was present in the minds of linguists and considered in their derived rules and principles. They did not try to interpret or correct it and return it to the rule, but rather surrounded it with a fence that preserves it as it was heard, and at the same time they did not allow measurement on it, in order to preserve the rule's place and consistency. [ABSTRACT FROM AUTHOR]

SMEs with network systems can sell their products and/or provide their services. The problem raised in this research basically focuses on the fact that SMEs in Ecuador without a website are at a disadvantage, since they need more communication. To solve this problem, a computer system was created that works as follows: online stores that allow SMEs to offer their products or services, recognize and accept online payments, and provide the possibility of analyzing sales for SMEs. The article detailed the processes involved in the implementation of the project. For the development of this activity, different stages were required to better understand the issues raised. [ABSTRACT FROM AUTHOR]

Purpose: Obtaining prior authorization (PA) before treatment is becoming increasingly burdensome in oncology, especially in radiation oncology. Here, we describe the impact of a strategic novel operational PA redesign to shorten authorization time and to improve patient access to cancer care at a large United States academic proton therapy center. We ask whether such a redesign may be replicable and adoptable across oncology centers. Materials and Methods: Our PA redesign strategy was based on a 3-tiered approach. Specifically, we (1) held payors accountable to legally backed timelines, (2) leveraged expertise on insurance policies and practices, and (3) updated the submission, appeal writing, and planning procedures for PA. Metrics were compared at the following 3 time points: 6 months before, at phase-in, and at 6 months after intervention. Results: In analyzing the impact of improving PA access to care, the percentage of approvals for commercial proton beam therapy improved by an absolute 30.6% postintervention (P < .001). The proportion of commercially insured patients treated with proton beam therapy also increased by 6.2%, and the number of new starts rose by 11.7 patients/mo. Overall patient census increased by 13 patients/d. Median authorization time was 1 week, and 90% of surveyed providers reported reduced PA burden and improved patient care. Conclusion: This is the first validated, comprehensive operational strategy to improve access to cancer therapy while reducing the burden of PA. This novel approach may be helpful for addressing barriers to PA in medical and surgical oncology because the redesign is predicated on laws that regulate PA across disciplines.

Copyright of Builder (1896-0642) is the property of PWB MEDIA Zdzieblowski sp.j. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Work on cultural evolution, especially that of Boyd, Richerson, and Henrich, has said little about the role of reinforcement in cultural learning. This is surprising, for reinforcement is an old system, it is found across a diverse array of organisms, and it is a successful concept in various scientific disciplines. The main claim of this paper is that social forms of reinforcement play a role in cultural evolution. More specifically, I argue that starting early in human history, social approval and disapproval of behavior function as reinforcers and punishers; approval and disapproval thereby start a process whereby norms are transmitted. After giving arguments for these claims, I discuss work on social learning strategies—cultural rules specifying who to learn from and how to learn from them (Heyes in Philos Trans R Soc 371(1693):1–8, 2016. ). I suggest that the account I develop here can help explain the connection between these learning rules and cultural evolution. I illustrate this point with recent work on divination practices (Hong and Henrich in Hum Nat 32:622–651, 2021. ). My account proposes that forms of social reinforcement can explain the spread and persistence of divination practices. Besides addressing the central question (a role for reinforcement in cultural evolution), my account indirectly touches on developing themes in cultural evolution, namely, normative psychology (Heyes in Perspect Psychol Sci, 2023; Birch Biol Philos 36:4, 2021. ). [ABSTRACT FROM AUTHOR]

Abstract Background Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia. Method This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions. Results Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value

The University of California Los Angeles (UCLA) and University of California San Francisco (UCSF) codeveloped 68Ga-PSMA-11 by conducting a bicentric pivotal phase 3 clinical trial for PET imaging for prostate cancer. On December 1, 2020, 2 separate new drug applications (NDAs) submitted by each institution (NDA 212642 for UCLA and NDA 212643 for UCSF) were approved by the Food and Drug Administration as the first drug for PET imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. This article briefly describes the background, clinical development, regulatory approach, and regulatory process for NDA filing and approval. In the second part of this article, key chemistry, manufacturing, and controls (CMC) information is provided to facilitate abbreviated new drug application (ANDA) submission.

Copyright of GeSec: Revista de Gestao e Secretariado is the property of Sindicato das Secretarias e Secretarios do Estado de Sao Paulo (SINSESP) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

In 1876, Charles Dodgson (better known as Lewis Carroll) proposed a committee election procedure that chooses the Condorcet winner when one exists and otherwise eliminates candidates outside the Smith set, then allows for re-votes until a Condorcet winner emerges. The present paper discusses Dodgson's work in the context of strategic election behavior and suggests a "Dodgson-Hare" method: a variation on Dodgson's procedure, for use in public elections. This method allows for candidate withdrawal and employs Hare's plurality-loser-elimination method to resolve persistent cycles. Given plausible assumptions about how candidates decide whether to withdraw when there is a cycle, Dodgson-Hare outperforms Hare, Condorcet-Hare, and 12 other voting rules in a series of spatial-model simulations that count how often each rule is vulnerable to coalitional manipulation. In the case of a one-dimensional spatial model, all coalitional voting strategies that are possible under Condorcet-Hare can be undone in Dodgson-Hare, by the withdrawal of candidates who have incentive to withdraw. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Young Intellectuals / Genç Mütefekkirler Dergisi is the property of Journal of Young Intellectuals and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The topic of this paper is the consent of a third party to the conclusion of a contract. The current lack of interest of legal science in the institution of third-party consent to contract is a consequence of its scattered normative regulation. Considering third-party consent is required often, in numerous and diverse cases, it is sporadically regulated in parts of regulations governing these contracts. Given the large number of cases where third-party consent to contract is required, this institution is sporadically regulated in parts of regulations governing individual contracts for which consent is required. Therefore, this paper examines contracts for which it is necessary to obtain third-party consent and which most often appear in legal transactions, such as contracts involving persons with limited business capacity, as well as consent required for the conclusion of sublease and sublicense contracts. This paper also includes an analysis of the current regulation of consent in the legislation of the Republic of Serbia, as well as an analysis of issues related to the form, legal nature, and consequences of the absence of third-party consent. The paper also presents a comparative legal analysis of solutions contained in the legislation of Germany, France, and Switzerland.

The Notary’s right of refusal through the approval of the Notary Honorary Council (NHC) hinders the practice of criminal law enforcement because it is absolute and there is no further (final) legal remedy, even though a similar policy (beleid) has been revoked by the Constitutional Court. In practice, the notary cannot be examined by investigators, public prosecutors, or judges, unless they have previously obtained NHC approval, as regulated in Article 66 paragraph (1) of Law Number 30 of 2004 as amended by Law Number 2 of 2014 (Notary Position Law). Even if Notary Honorary Council refuses, then there will only be further legal remedies through a lawsuit by the State Administrative Court. In fact, the provisions regarding the Notary’s right of refusal should be ‘determination’ by court decisions (vonnis) as regulated in Article 170 of the Criminal Code, and not ‘administrative determination’ (beschikking) through NHC approval based on the delegation of supervisory authority from state institutions. This paper concludes that every law enforcer in criminal cases (police, prosecutors, and judges) can examine a Notary with the condition of special permission from the Head of the local District Court, approval of direct interested parties, or NHC approval as stipulated in Article 43 of the Criminal Code in conjunction with Article 66 paragraph (1) of the Notary Position Law. This paper is normative research with a statutory approach, conceptual approach, and case approach.

Background: Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia. Method: This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions. Results: Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review. Conclusion: Saudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies. [ABSTRACT FROM AUTHOR]

Double‐headed studs as shear and punching reinforcement – Current status and outlook Double‐headed studs have been established for decades as a very effective punching shear reinforcement because these reinforcement elements, which are optimized for shear and punching loads, combine a particularly high anchorage performance with a practicable installation on site. In this paper, an overview of current usability and applicability verifications for double‐headed studs in Germany is given. Afterwards, the currently valid design and construction rules for the use of double‐headed studs as shear reinforcement as well as punching reinforcement are summarized. Finally, the next Eurocode 2 generation 2023+is looked at, with excerpts presenting some significant innovations in the future integration of double‐headed studs into the shear and punching rules. [ABSTRACT FROM AUTHOR]

Non-invasive brain stimulation techniques (NIBS) have been widely used in both clinical and research contexts in neuropsychiatry. They are safe and well-tolerated, making NIBS an interesting option for application in different settings. Transcranial magnetic stimulation (TMS) is one of these strategies. It uses electromagnetic pulses for focal modulate ion of neuronal activity in brain cortical regions. When pulses are applied repeatedly (repetitive transcranial magnetic stimulation—rTMS), they are thought to induce long-lasting neuroplastic effects, proposed to be a therapeutic mechanism for rTMS, with efficacy and safety initially demonstrated for treatment-resistant depression (TRD). Since then, many rTMS treatment protocols emerged for other difficult to treat psychiatric conditions. Moreover, multiple clinical studies, including large multi-center trials and several meta-analyses, have confirmed its clinical efficacy in different neuropsychiatric disorders, resulting in evidence-based guidelines and recommendations. Currently, rTMS is cleared by multiple regulatory agencies for the treatment of TRD, depression with comorbid anxiety disorders, obsessive compulsive disorder, and substance use disorders, such as smoking cessation. Importantly, current research supports the potential future use of rTMS for other psychiatric syndromes, including the negative symptoms of schizophrenia and post-traumatic stress disorder. More precise knowledge of formal indications for rTMS therapeutic use in psychiatry is critical to enhance clinical decision making in this area. [ABSTRACT FROM AUTHOR]

Copyright of Prometeo Conocimiento Científico is the property of Puerto Madero Editorial Academica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: The world has made great strides towards beating malaria, although about half of the world population is still exposed to the risk of contracting malaria. Developing an effective malaria vaccine was a huge challenge for medical science. In 2021 the World Health Organization (WHO) approved the first malaria vaccine, RTS,S/AS01 vaccine (Mosquirix™), for widespread use. This review highlights the history of development, and the different approaches and types of malaria vaccines, and the literature to date. It covers the developmental stages of RTS,S/AS01 and recommends steps for its deployment. The review explores other potential vaccine candidates and their status, and suggests options for their further development. It also recommends future roles for vaccines in eradicating malaria. Questions remain on how RTS,S vaccine will work in widespread use and how it can best be utilized to benefit vulnerable communities. Conclusion: Malaria vaccines have been in development for almost 60 years. The RTS,S/AS01 vaccine has now been approved, but cannot be a stand-alone solution. Development should continue on promising candidates such as R21, PfSPZ and P. vivax vaccines. Multi-component vaccines may be a useful addition to other malaria control techniques in achieving eradication of malaria. [ABSTRACT FROM AUTHOR]

Copyright of College of Law Journal for Legal & Political Sciences / Magallat Kulliyyat Al-Qanun Li-L-ulum Al-Qanuniyyat Wa-Al-Siyasiyyat is the property of Republic of Iraq Ministry of Higher Education & Scientific Research (MOHESR) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Therapeutic genome editing is currently reshaping and transforming the development of advanced therapies as more ex vivo and in vivo gene editing-based technologies are used to treat a broad range of debilitating and complex disorders. With first-generation gene editing modalities (notably those based on ZFNs, TALENs and CRISPR/Cas9), comes a new second-generation of gene editing-based therapeutics including base editing, prime editing and other nuclease-free genome editing modalities. Such ground-breaking innovative products warrant careful considerations from a product development and regulatory perspective, that take into account not only the common development considerations that apply to standard gene and cell therapy products, but also other specific considerations linked with the technology being used. This article sheds light into specific considerations for developing safe and effective in vivo and ex vivo genome editing medicines that will continue to push barriers even further for the cell and gene therapy field. [ABSTRACT FROM AUTHOR]

In conditions of current economic difficulties in the Russian Federation the process of individuals’ crediting is still one of the most important lines in supporting and developing the bank sector in the country. Individuals’ crediting is a type of bank crediting, which stipulates cash provision on the loan basis to the population in order to satisfy people’s different needs: purchase of consumer goods, payment of services, buying cars, construction or purchase of housing and real estate of customer purpose. Individuals’ crediting has a multi-purpose character, which results in availability of its different types. For the last decade consumer crediting has shown a serious growth, however the present situation can drastically change. The article provides findings of the research dealing with the process of individuals’ crediting in the Russian Federation and shows analytical materials dated 2010–2020. The author conducted the dynamic analysis of individuals’ crediting, studied information about loan applications and their approvals of potential borrowers, including wage clients, banks and demonstrated a share of borrowers’ credits in certain banks. The author also provided the results of forecasted volumes of credits to individuals up to 2024 by the trend equation with using possibilities of applied programs Statistica 8.0 package.

Coronavirus disease 2019, responsible for a global pandemic, is caused by the severe acute respiratory syndrome coronavirus 2. Several vaccines have been developed and approved worldwide, particularly in China. As of Oct 17, 2021, four new coronavirus vaccines in China have been conditionally approved for marketing by the National Medical Products Administration, two of which have been authorized for emergency use in the Emergency Use Listing of the World Health Organization. Domestic vaccine R&D in China has relied on legal and regulatory support. This article summarizes the regulatory policy for vaccine development, review and approval. Vaccine approval laws have been continually improved, and regulations for special approval have been used to shorten the review time. China has coordinated pandemic-related needs, both domestically and with other countries, and made substantial progress in cooperative international anti-pandemic efforts.

The epidemic of coronavirus disease 2019 is a severe test for China′s response to major public health emergencies. Through literature reviews, we summarized approval system and process for research/development and marketing of medicine and test reagents related to responses to major public health emergencies in many foreign countries and conducted comparative studies on the system and process at home and abroad for providing references to relevant system construction and administrative management China.

National building regulations in most countries are part of the law and an important professional subject for many construction professionals, including engineers and architects. In addition to construction plans with titles such as approved plans that are available with the seal and signature of the designer and approved by the municipality and the Construction Engineering Organization, other plans are prepared that are used in the implementation and are called executive plans. Since it is specified in all the regulations and even in the Article 100 Commission of the municipalities of Iran, the approved plans are the criterion for reviewing and evaluating the degree of compliance of the construction plans with the laws and regulations. Thus, the discrepancy between the approved and executive plans has led to the formation of violations and non-compliance with the rules and regulations of architecture and urban planning. In order to prevent construction violations, it is necessary to study the nature of this issue and the causes of violations in every way. This study is applied research in terms of purpose, and descriptive, causal, correlational and survey in terms of method. Data was collected by library and field methods through the distribution of questionnaires. Based on the research findings, there are two types of attitudes: The first attitude is municipalities' revenue-generating towards the phenomenon of construction violations, considering fines as a source of revenue, and the inefficiency of the construction monitoring system. The second is the attitude of architectural designers in examining the four main design factors (form, performance, economy, and time), the motivation of owners to make more profit by increasing the lot coverage, designers' freedom of action in executive plans due to non-responsibility, less control of licensing authorities on executive plans, etc. Accordingly, it was found that there is a relationship and correlation between increasing the number of executive plans and increasing construction violations. Therefore, providing sustainable revenue sources, improving the municipal construction monitoring system, improving the licensing bureaucracy in municipalities, and legalizing building plans can help reduce construction violations.

The article investigates the phenomenon of fascination in the context of modern approach to interpersonal communication in cooperative and nonviolent way. Effectiveness of communication process mainly depends on the quality of interpersonal relations, the degree and quality of emotions, the willingness of communication partners to adjust to verbal contact. We shall undertake linguistic analysis of fascination as one of discursive strategies. Fascination is defined as the person's quality to be liked via peculiar semiotic way of self-presentation, aimed at minimizing unpleasant emotional tone in communication and maximizing positive communication climate. According to fascination's nature to enchant, charm, express sympathy, elicit negative emotions and make positive impression, it can be stated that positive communication climate is created by special fascinating way of communication. Such kind of communication is made up of a system of verbal and nonverbal components and connections between the fascinator and the object of fascination. As fascination is able to change emotional state and create positive tone in interpersonal relations, we consider fascination as supportive strategy of positive communication climate. The purpose of our study is to explore fascination as supportive strategy in relation to making positive communication climate. [ABSTRACT FROM AUTHOR]

What are the origins of gubernatorial popularity? Past studies debate whether governors are substantively evaluated based on their performance in office, with some arguing that the origins of approval may be idiosyncratic to particular governors. These studies typically consider gubernatorial approval in a handful of states or patterns of approval in the aggregate. We improve on this research by drawing on a richer data source: the Cooperative Congressional Election Study. We consider both individual-level and state-level explanations of gubernatorial popularity with a sample of over 300,000 respondents across the 50 states from 2006 to 2018. We explore how party, policy outcomes, and government performance shape levels of gubernatorial approval. We show that people evaluate governors based on the ideological direction of policy outcomes in the states. When state policy outcomes align with their ideological preferences, people report higher levels of approval for the job performance of their governor. We also confirm the importance of party and state economic performance for gubernatorial approval. [ABSTRACT FROM AUTHOR]

The technology of HVDC systems defines the current return process, which can be through a dedicated metallic conductor or through a conducting medium, such as the earth or sea. Although the magnitude of the earth/sea return current is normally specified in local regulations or project specifications, there is no explicit methodology to estimate the intermittent, time duration of this current, over the life-span of a system. However, dc interference/corrosion impacts related to the development of HVDC links are, to a large extent, associated to the time duration of the earth current. In the absence of any explicit methodology, the potential influence of the earth/sea return current on nearby critical infrastructures is often based on unrealistic or on conservative interference impact studies. The purpose of this paper is to firstly provide a methodology to quantify the expected intermittent duration of the earth return current - in point-to-point bipolar HVDC systems, which arises from their partial-availability or the emergency conditions. Subsequently, the proposed methodology is applied in a realistic dc interference/corrosion study of a critical pipeline system that operates near a HVDC link currently being constructed. In essence, the paper describes a top-down complete approach for HVDC dc interference modelling endeavors in an attempt to avoid conservative and costly mitigation measures concerning third-party critical infrastructures in the nearby vicinity.

This study investigates the use of print titles purchased on approval and how quickly they become available as ebooks. Using this information, we explore the potential impact on patrons if the library was to move to a demand driven acquisitions process for print books. We found that at our library, the low overall usage of print titles received on approval indicates that patrons would be minimally inconvenienced by switching to this method in which records would be loaded into the catalog and titles would only be purchased when requested. Additionally, we found that the impact on patrons decreases over time as more titles become available as ebooks. Although differences exist between disciplines, overall findings show that a demand driven acquisitions process for print books would result in substantial budgetary savings without sacrificing patron service at our library. In addition to the description of our program, we describe some data analysis methods that can be used at other libraries in order to estimate potential impact on patron service and satisfaction. [ABSTRACT FROM AUTHOR]