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Despite the importance of a thriving workforce in sustaining organizational success, prior research pays little attention to how individualized human resource (HR) practices can help individual employees to thrive at work. Drawing on the theoretical underpinnings of conservation of resources theory, we investigate whether, how, and when development idiosyncratic deals (i‐deals) can contribute to individual thriving. We contend that possessing development i‐deals will motivate individuals to engage in approach job crafting, which in turn promotes their experience of thriving at work. We further contend that high‐quality leader–member exchange will enhance the function of development i‐deals in triggering approach job crafting and subsequent thriving experiences. Results from a two‐wave survey involving 278 managers in a pharmaceutical firm in China and a three‐wave survey among 178 managers working in various organizations in the UK support our hypotheses. Our findings provide new insights for practitioners seeking to design customized HR practices to support a thriving workforce. [ABSTRACT FROM AUTHOR]

The rapid growth of pharmaceutical refrigerated logistics poses sustainability challenges, including elevated costs, energy consumption, and resource inefficiency. Collaborating multiple depots can enhance logistics efficiency when standalone distribution centres have limited transport resources, i.e. refrigerated vehicles. However, the sustainable benefits and performance across different strategies remain unexplored. This study fills this research gap by addressing a refrigerated pharmaceutical routing problem. While many collaborative strategies prioritise economic and environmental benefits, our approach highlights a vital social indicator: maintaining vehicle flow equilibrium at each depot during collaboration. This ensures the stability of transport resources for all stakeholders, promoting sustainable collaborative logistics. The problem is formulated as a multi-depot vehicle routing problem with time windows (MDVRPTW). Three collaborative strategies using Clustering VRP (CLUVRP) and improved Open VRP (OVRP) are proposed and compared. We develop two approaches to address traditional OVRP limitations in ensuring vehicle flow equilibrium at each depot. Our models consider perishable pharmaceuticals and time-dependent travel speeds. Three hybrid heuristics based on Simulated Annealing and Variable Neighborhood Search (SAVNS) are proposed and evaluated for efficacy. Computational experiments and a case study demonstrate distinct sustainable benefits across various strategies, offering valuable insights for decision-makers in the refrigerated logistics market. [ABSTRACT FROM AUTHOR]

We study a production lot-sizing problem inspired by a veterinary pharmaceutical plant in which demands are uncertain. First, we develop a deterministic capacitated lot-sizing model for the production of animal pesticides, performed in three machine-specific stages. Second, we propose a traditional robust optimisation formulation following the popular budget-of-uncertainty approach. Third, we derive a novel fragility-based approach that circumvents well-known issues with traditional robust optimisation approaches, such as the estimation of budgets of uncertainty, the over-conservatism of robust solutions and the sensitivity of solutions to the decision maker's risk attitude. The fragility-based approach is grounded in the idea of minimising violations, over the full uncertainty support, from a user-specified cost target. It avoids the estimation of budgets of uncertainty and produces less conservative solutions via explicit modelling of constraint violation. We demonstrate the effectiveness of our approach on instances built upon real data provided by our industrial partner, a major player in the Brazilian veterinary pharmaceutical sector. The results show that our fragility-based approach reduces average total costs across all instances and maintains greater model stability under different target estimations. It also preserves cost savings when bottlenecks are introduced in production and when inventory costs and capacities are varied. [ABSTRACT FROM AUTHOR]

How does a firm's response time to past failures affect its likelihood of experiencing future failures? Does this likelihood depend on the reasons for past failures? Using drug recalls during 2006–2016, we examine the effect of pharmaceutical firms' response time to their past failures on their learning from failure. Longer response times reduce the likelihood of subsequent failure. Variations in the reasons for past failures increase the potential for subsequent failure. However, a longer response time helps overcome the challenges associated with this variation. By focusing on the temporal dimension of learning from failure, we provide unique theoretical insights into when and how organizations can learn from failure. [ABSTRACT FROM AUTHOR]

In our paper, we encompass the topic of socioeconomic disparities intrinsic to drug pricing and look at ways to ensure that every individual in the United States can access antibiotics equally and equitably. In the United States, a multitude of individuals find themselves struggling with high, out-of-pocket costs for necessary antibiotics or medications.  These issues are generally caused by factors surrounding monopolistic drug markets, high costs for development, and the severity of disease that an individual is facing. We explore these challenges from a plethora of perspectives, such as; the role of specialty pharmacies, limited distribution networks, and the usage of psychotropic medications among youth with Autism Spectrum Disorders (ASD). High prices and restricted access of certain antibiotics for conditions like Hepatitis C highlight the systemic and intrinsic issues within the pharmaceutical industry and how it affects individuals who suffer from this disease or diseases similar to it. On a similar topic to that, ongoing shortages of ADHD medications continue to show the consistent and heavy impact of supply constraints amongst the pharmaceutical industry in the United States. We discuss potential solutions, including but not limited to, accelerating the approval of basic drugs, implementing ceiling prices to prevent high costs, and better integrating health-system specialty pharmacies. By concentrating on the need for policy reforms within the United States and collaboration amongst the various stakeholders that remain involved with drug pricing disparities, this study aims to offer a varied approach in reducing drug pricing disparities and making necessary medications accessible to every individual in the United States, regardless of socioeconomic or health status.

After decades, dialogues on human resource management (HRM), intellectual capital (IC), and ambidexterity still continue, mirroring that the role of ambidextrous capability in translating the impact of HRM into superior performance remains unclarified. At this juncture, the current study proposes a novel theoretical framework to extend research on the relationship between IC‐enhancing HR practices and innovation. It is done sophisticatedly by examining how firm exploitative and exploratory capabilities mediate the relationship between different combinations of HR configurations and firm innovation. To this end, we designed rigorous time‐lagged research with three waves of data collection from the Iranian healthcare sector. Our analyses revealed that firm explorative and exploitative capabilities significantly mediate the relationship between human, social, and organizational capital‐enhancing HR configurations and firm innovation. More conspicuously, by unraveling interaction patterns among distinct HR configurations, our study revealed the intricacies of the functioning of IC‐enhancing HR practices in fueling firm ambidexterity. Hence, our study offers design options to navigate through exploitation and exploration in light of the firm's core innovation strategy. We discuss the theoretical and practical implications of our findings and suggest future research avenues. [ABSTRACT FROM AUTHOR]

Extant research has shown that it is harder for women than for men to form high-status connections in the workplace. Extending this line of research, we examine how two structural factors—geographic and network proximity—affect men's and women's chances of forming high-status connections. Using data on the formation of collaboration ties with star scientists within the research and development laboratories of the 42 largest pharmaceutical companies between 1985 and 2010, we show that women who are geographically colocated with a "star" colleague are less likely to form a tie with that colleague compared to male peers who are similarly colocated, and that this difference persists irrespective of the star's gender. Conversely, women benefit more than men do from network proximity, as indicated by the presence of common third-party ties, and this difference widens if the star colleague is also a woman. By illuminating how geographic and network proximity affect the chances of forming high-status connections differently for women than for men, our study goes beyond the notion that women have reduced access to workplace social capital and expands consideration to the structural factors that underpin—that is, amplify or reduce—that disadvantage. [ABSTRACT FROM AUTHOR]

The rise of liberal market economies, propagated by neoliberal free market thought, has created a vacant responsibility for public interests in the market order of society. This development has been critiqued by Catholic social teaching (CST), forcefully arguing that governments and businesses should be directed to the common good. In this debate, no attention has yet been given to the Reformational tradition and its principle of sphere sovereignty, which provides guidelines on the responsibilities of governments and companies for the public interest of society. This article analyzes the differences and similarities between CST and the Reformational philosophy in their critiques of the neoliberal free market perspective of Hayek. We apply the three perspectives to the case of orphan drugs in the pharmaceutical industry and show that CST and the Reformational philosophy offer valuable insights in correction to Hayek's views on the responsibilities of governments and companies for public health interests. [ABSTRACT FROM AUTHOR]

In theory, financial markets promote innovation by selectively allocating capital to high-quality projects. In this article, I show that equity markets can also inhibit innovation. In public firms, I find that short-term equity market declines cause pharmaceutical companies to abandon early-stage drug developments, irrespective of drug quality or changes in a firm's stock price. I show that financing constraints drive this behavior, highlighting that even short-term market fluctuations can have long-term effects on pharmaceutical innovation and prevent potentially life-saving drugs from progressing to the market. [ABSTRACT FROM AUTHOR]

The article presents a speech by Diane B. Ginsburg, associate dean for healthcare partnerships, clinical professor in the division of pharmacy practice and G.D. Searle Endowed Fellow in Pharmacy at The University of Texas at Austin College of Pharmacy, delivered at the Harvey A.K. Whitney Lecture. Topics discussed include her selection as a recipient of the Harvey A.K. Whitney Lecture Award, the purpose of pharmacy, and issues facing the profession.

Alginates, hydrophilic anionic polysaccharides with notable bioactivity and biocompatibility, have drawn significant attention, particularly due to their extensive use in the pharmaceutical industry and associated health benefits. Brown seaweeds serve as the primary source of alginates. However, extraction methods, especially traditional ones, face efficiency challenges, impacting the yield. Green extraction methods promise an eco-friendly alternative, but their industrial-scale implementation is still unproven. Importantly, these extraction methods could yield alginates of different molecular weights and consequent varied biological effects. Alginates possess antibacterial, antioxidant, anti-diabetic, and immunomodulatory properties, forming the cornerstone of their health benefits and pharmaceutical applications. The hydrogel formation characteristic of alginates is crucial for pharmaceutical applications, including drug delivery, wound dressing, and tissue regeneration. Despite the existence of numerous articles exploring the extraction methods, properties, and applications of alginates, a gap exists in the literature that connects these aspects with health benefits. This review aims to bridge this gap by providing a comprehensive discussion of the extraction methods, properties, health benefits, and pharmaceutical applications of alginates. [ABSTRACT FROM AUTHOR]

The European Commission (EC) has tasked the European Medicines Agency (EMA) to provide a recommendation towards the acceptability of titanium dioxide (TiO 2) in pharmaceutical products by early 2024 to inform on final decision in early 2025[1]. Unlike the already implemented ban of TiO 2 in foods, removing this excipient from pharmaceutical products will likely have significant impact on the pharmaceutical industry, regulatory agencies, and patients. This commentary explores the challenges facing the pharmaceutical industry tasked with supporting the development and registration of TiO 2 free (TF) drug products. Specifically, justification of formulation changes and potential impact to in vitro and in vivo performance, as well as differences in global regulatory comparative dissolution requirements to justify changing to TF drug product are discussed. Particularly, the uncertainties around how a formulation change such as removal of TiO 2 from immediate release solid oral dosage forms will be viewed in Europe compared to other regions is discussed. To respond to these challenges and avoid disruption to the medicines supply chain in case in vitro data such as dissolution is either too challenging or insufficient to justify changing to TF product, pharmaceutical companies may have to decide if the level of risk is worth the effort needed to reformulate, develop, and register a new TF product. [ABSTRACT FROM AUTHOR]

This paper examines how accumulated internal R&D investment and foreign technology in-licensing experience independently and interactively affect creative imitation by latecomer firms. Based on the data of 61 listed Korean pharmaceutical firms over 19 years (1999 ∼ 2017), we showed that either accumulated internal R&D investment or foreign technology in-licensing experience has a positive impact on the development of creative imitation by latecomer firms. However, we found that a simultaneous increase in accumulated internal R&D investment and foreign technology in-licensing experience leads to less creative imitation outcomes, implying the existence of an internal tension between these two learning modes. [ABSTRACT FROM AUTHOR]

Background: Inflammation and immunity contribute pivotally to diverse acute and chronic diseases. Inflammatory pathways have become increasingly targets for therapy. Yet, despite substantial similarity in mechanisms and pathways, the scientific, medical, pharma and biotechnology sectors have generally focused programs finely on a single disease entity or organ system. This insularity may impede progress in innovation and the harnessing of powerful new insights into inflammation biology ripe for clinical translation. Methods: A multidisciplinary thinktank reviewed highlights how inflammation contributes to diverse diseases, disturbed homeostasis, ageing and impaired healthspan. We explored how common inflammatory and immune mechanisms that operate in key conditions in their respective domains. This consensus review highlights the high degree of commonality of inflammatory mechanisms in a diverse array of conditions that together contribute a major part of the global burden of morbidity and mortality and present an enormous challenge to public health and drain on resources. Results: We demonstrate how that shared inflammatory mechanisms unite many seemingly disparate diseases, both acute and chronic. The examples of infection, cardiovascular conditions, pulmonary diseases, rheumatological disorders, dementia, cancer and ageing illustrate the overlapping pathogenesis. We outline opportunities to synergize, reduce duplication and consolidate efforts of the clinical, research and pharmaceutical communities. Enhanced recognition of these commonalties should promote cross‐fertilization and hasten progress in this rapidly moving domain. Conclusions: Greater appreciation of the shared mechanisms should simplify understanding seemingly disparate diseases for clinicians and help them to recognize inflammation as a therapeutic target which the development of novel therapies is rendering actionable. [ABSTRACT FROM AUTHOR]

Aims: This study examines microencapsulation as a method to enhance the stability of natural compounds, which typically suffer from inherent instability under environmental conditions, aiming to extend their application in the pharmaceutical industry. Methods: We explore and compare various microencapsulation techniques, including spray drying, freeze drying, and coacervation, with a focus on spray drying due to its noted advantages. Results: The analysis reveals that microencapsulation, especially via spray drying, significantly improves natural compounds' stability, offering varied morphologies, sizes, and efficiencies in encapsulation. These advancements facilitate controlled release, taste modification, protection from degradation, and extended shelf life of pharmaceutical products. Conclusion: Microencapsulation, particularly through spray drying, presents a viable solution to the instability of natural compounds, broadening their application in pharmaceuticals by enhancing protection and shelf life. [ABSTRACT FROM AUTHOR]

Anthocyanins, a type of phenolic compound, are found in plants. They are high-value food and pharmaceutical ingredients with improved health benefits and biological functions. However, there are certain drawbacks to using anthocyanins in the food and pharmaceutical industries, such as low stability and vulnerability to severe environmental conditions such as light, pH, temperature, and oxygen which could have a significant impact on the health-promoting properties. Encapsulation is one of the most preferred processing methods since it helps preserve the health benefits of anthocyanin. Choosing an appropriate strategy entails consideration of processing parameters, equipment availability, and application aims. Electrospun nanofibers were used as a novel platform for anthocyanin encapsulation. Because of their superior properties, they can improve the encapsulation efficiency, bioactivity, and bioaccessibility of anthocyanin. The current review examines the chemical structure of anthocyanin and the principles and advantages of electrospinning as an encapsulating method in depth. Finally, the current limitations and opportunities for advancing electrospinning in food packaging and medicine delivery are explored. [ABSTRACT FROM AUTHOR]

Despite regulatory changes designed to stimulate investment in therapies for rare diseases, many of these conditions lack government-approved treatments. Advanced regenerative medicines, which are therapies and clinical interventions aimed at healing or replacing damaged or defective human cells, tissues, and organs, offer great promise for addressing many rare diseases. A major challenge facing advanced regenerative medicines for rare diseases is securing financial support to assist in bringing a therapy to market. This paper describes the factors cited by pharmaceutical industry players globally for sponsoring the development of advanced regenerative medicines for rare diseases. The paper examines the motivations of 53 sponsors that meet the latter criteria. The motivations behind investments were broadly similar amongst sponsors and map closely onto regulatory requirements for clinical development and marketing authorization of advanced therapeutic products, including the presence of accelerated or attenuated pathways for regulatory approval, use for indications with high unmet medical needs, and/or that have advantages over existing therapies, and robust preclinical data. Other factors include availability of investment incentives and opportunities for off-label use in the post-approval stages. [ABSTRACT FROM AUTHOR]

Introduction: The European Medicines Agency Innovation Task Force (ITF) acts as early point of contact for medicine and technology developers to enable innovation during early drug development stages through ITF briefing meetings. Aim: To reflect on the current pace of innovation and to assess the potential of ITF stakeholder interactions, a comprehensive analysis of the ITF briefing meetings held between 2021 and 2022 was conducted with a focus on individual questions raised by the developers and the related feedback provided by the European regulators. Methods: Questions raised during ITF briefing meetings were extracted and categorised into main and sub-categories, revealing different themes across the whole medicine development process such as manufacturing technologies, pre-clinical developments, and clinically relevant questions. Results: There was positive feedback from regulators who gave initial guidance in 85% of the answers, provided concrete examples in 20% of the answers and recommended to continue discussions through additional regulatory procedures in 22% of the answers. Conclusion: This analysis frames the content and the type of topics discussed during ITF briefing meetings. Moreover, it describes the type of regulatory feedback provided to medicine developers and identified potential for improvement of these early interactions. Therefore, this analysis emphasises the role of ITF briefing meetings in fostering innovation in medicine. [ABSTRACT FROM AUTHOR]

Purpose: TransCelerate BioPharma surveyed its member biopharmaceutical companies to understand current practices and identify opportunities to complement safety signal assessment with rapid real-world data (RWD) analysis. Methods: A voluntary 30-question questionnaire regarding the use of RWD in safety signal assessment was disseminated to subject matter experts at all TransCelerate member companies in July 2022. Responses were blinded, aggregated, summarized, and presented. Results: Eighteen of 20 member companies provided responses to the questionnaire. Sixteen (89%) companies reported actively leveraging RWD in their signal assessment processes. Of 18 respondent companies, 8 (44%) routinely use rapid approaches to RWD analysis, 7 (39%) utilize rapid RWD analysis non-routinely or in a pilot setting, 2 (11%) are considering using rapid RWD analysis, and 1 (6%) has no plans to use rapid RWD analysis for their signal assessment. Most companies reported that RWD adds context to and improves quality of signal assessments. To conduct RWD analysis for signal assessment, 16 of 17 (94%) respondent companies utilize or plan to utilize internally available data, 8 (47%) utilize both internal and external data, and 3 (18%) utilize data networks. Respondents identified key challenges to rapidly performing RWD analyses, including data access/availability, time for analysis execution, and uncertainties regarding acceptance of minimal or non-protocolized approaches by health authorities. Conclusion: Biopharmaceutical companies reported that they see value in the use of rapid RWD analyses for complementing signal assessments. Future work is recommended to offer a framework and process for use of rapid use of RWD analyses in signal assessment. [ABSTRACT FROM AUTHOR]

The increasing global drug shortage poses a substantial challenge to national healthcare systems and affects access to essential therapies. In Japan, this problem is exacerbated by a large-scale government campaign to switch from brand-name products to generic drugs and manufacturing/marketing authorization holders with poor development and manufacturing controls. Regulatory bodies, such as the U.S. Food and Drug Administration and the European Medicines Agency have developed guidelines aimed at ensuring continuous drug supply and mitigating manufacturing risks. However, Japan's efforts have primarily relied on voluntary industry guidelines, lacking the robust regulatory frameworks of other developed nations. Therefore, this study proposes a draft guideline for Japan's pharmaceutical industry to manage drug shortages effectively. The Japanese government needs to establish a framework system that will enable pharmaceutical companies to effectively maintain a stable supply based on the proposals developed in this study. [ABSTRACT FROM AUTHOR]

Post-approval changes (PACs) to marketed products are routinely introduced to continuously enhance the product lifecycle management. However, bringing a chemistry, manufacturing and control (CMC) change through the global health authorities can be a complex and lengthy process taking up to several years, therefore negatively impacting supply continuity. In order to accelerate the review and approval of regulatory submissions and ensure continuous supply to patients, the World Health Organization (WHO) is strongly supporting the implementation of reliance among National Regulatory Authorities (NRAs). While some promising developments have been made with the use of reliance pathways for initial marketing authorizations, reliance is still not widely used for PACs. With the support of the European Medicines Agency (EMA) and WHO, Roche launched a reliance pilot based on EMA approval to file a supply critical variation for a monoclonal antibody. The variation constitutes major changes to the approved manufacturing process. Sameness of the product is ensured by submitting to all participants the same variation package as in the EU. The objectives of the pilot are to ensure continuous supply of this critical medicine by targeting global approval in 6.5 months, to promote regulatory convergence by waiving country specific requirements, and enhance greater transparency by sharing EMA Committee for Medicinal Products for Human Use (CHMP) final assessment report and Q&As to participating NRAs. Globally 48 NRAs have agreed to join the pilot. This article outlines the process of establishing the pilot project, including a planning phase and an engagement phase with the EMA, WHO and the participating NRAs. [ABSTRACT FROM AUTHOR]

COPD and asthma are two of the most common chronic lung diseases, affecting over 545 million people globally and 34 million in the United States. Annual health care costs related to chronic lung disease are estimated at €380 billion in the European Union, and $24-$50 billion in the United States averaging to $4,000 in out-of-pocket costs per person in the U.S. A full-text literature search was conducted for English publications between January 1, 2005-March 18, 2024. It returned over 5,000 publications that were further narrowed using key search words, resulting in 172 peer-reviewed articles. Using their experience and subject expertise, the authors further narrowed the peer-reviewed articles to 55 that were in their opinion relevant. Also, 38 recently published industry reports and news articles specific to downstream effects of inhaler market changes and the future impact were included. The literature suggests that individuals with chronic lung disease face increased challenges with access to inhaled medication due to rising medication costs, discontinuation of branded medications, introduction of generic medications not covered by insurance, exclusionary preferred drug list tactics that force health care providers into non-medical switching of medication or devices, and ongoing medication shortages. Providers experience ongoing hurdles in prescribing appropriate inhaled medications for individuals with chronic lung disease, including increased time and costs spent on administrative tasks due to inhaler denials, a loss of patient trust, and limits on their ability to prescribe appropriate inhaled medication for individuals with chronic lung disease. [ABSTRACT FROM AUTHOR]

Background: In recent years, the pharmaceutical industry in Germany has faced a significant decline in the number of clinical trials conducted. Methods: This study evaluates patient participation in clinical trials for oncology and chronic diseases in Germany, integrating quantitative and qualitative research. Data from the Institute for Applied Health Research Berlin (InGef (Institut für angewandte Gesundheitsforschung, Berlin, Germany)), covering about 88% of the German population, and expert interviews were used. Results: In 2022, 84.6% of 47,305 systemic lupus erythematosus patients (SLE) and 11.9% of 102,300 chronic lymphocytic leukemia patients (CLL) received guideline-based care based on study definitions. Eligibility for clinical trials between 2017 and 2022 was estimated for 8272 SLE and 886 CLL patients, with the actual enrolment of 21 of 2221 SLE patients and 86 of 340 CLL patients reflecting the respective potential. Conclusions: Findings indicate an unexploited potential to enroll patients with chronic diseases compared to the relatively higher enrolment rates observed for oncology diseases, such as CLL. Securing the continuation of clinical trials and utilizing the value of trial participation is of importance for strengthening Germany as an innovation hub and for ensuring that patients have timely access to medical innovations. [ABSTRACT FROM AUTHOR]

Copyright of Wirtschaft und Wettbewerb is the property of Fachmedien Otto Schmidt KG 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.)

Purpose: The Indian pharmaceutical industry currently faces multiple challenges, including rising costs and slowing export growth, which in turn have limited its ability to expand presence in global canvas. Given the nature of sectoral dynamics, a pharmaceutical firm must undertake huge investments in R&D to introduce product innovation, in turn enhancing market share and sustaining profit streams. The development of novel medicines, confirmed by the granting of patent rights, provides a pharma company edge over its competitors. In addition, presence of innovator firms within the industry invigorates the sectoral value chain and raises efficiency. Hence, it is important to analyze whether granting patent rights enhances the exports of pharmaceutical products in the Indian context. Design/methodology/approach: The current study explored this question using a simultaneous-equation framework. Specifically, the authors use the methods developed by Davidson and MacKinnon (1993) and Greene (2003) to obtain heteroscedasticity-consistent estimates. The time-series properties of the data were further probed, and robust estimates were used to test the theory. Methods developed by Baltagi (1981) have been used further to refine the authors' estimations. Findings: After controlling for relevant variables, it is observed that granting of patents caused a significantly positive impact on pharmaceutical exports. Furthermore, the change in the patent administration regime had a significant impact on patent fillings, which further impacted their exportability. Compared to patents granted patents filed had a higher impact on pharmaceutical exports. Originality/value: This study attempts to apply the framework developed by Goldstein and Khan (1978) with necessary modifications to suit the context of a developing country. The application of the 3SLS method to estimate the export supply equation for pharmaceutical products is a novel approach to the research question in general and to the Indian context in particular. System autocorrelation and heteroscedasticity tests were performed to refine the results further. [ABSTRACT FROM AUTHOR]

Copyright of Umsatzsteuer-Rundschau is the property of De Gruyter 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.)

Copyright of Umsatzsteuer-Rundschau is the property of De Gruyter 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: Financial relationships between clinical guideline authors and pharmaceutical companies introduce conflicts of interest (COI), potentially biasing guideline recommendations. Thus, proper management of COI is paramount for clinical guideline authors. Nevertheless, little is known about COI among neurology clinical guideline authors. This study aimed to evaluate the financial relationships between pharmaceutical companies and authors of Clinical Practice Guideline for Headache Disorders (CPGHD) in Japan. Methods: This is a retrospective analysis of 2016–2020 personal payments data disclosed by all pharmaceutical companies affiliated with the Japan Pharmaceutical Manufacturers Association. We examined amounts and fraction of personal payments to all 57 CPGHD authors and all neurologists board-certified by the Japanese Society of Neurology. Payment data was descriptively analyzed at individual author level. Results: Among 57 CPGHD authors, 56 (98.3%) received personal payments totaling $2.7 million from pharmaceutical companies between 2016 and 2020. Median five-year payments were $89,955 for CPGHD authors, while $521 for board-certified neurologists. The CPGHD chairperson and vice chairperson received substantial payments during the guideline development period. Nevertheless, because of less rigorous and transparent COI policy compared to international standard policies, only 10 authors disclosed their financial relationships with the pharmaceutical companies in the guideline. Conclusions: More than 98% of CPGHD authors received much higher personal payments from pharmaceutical companies than those to board-certified neurologists during the guideline development period in Japan. [ABSTRACT FROM AUTHOR]

Glass vials are the most widely used primary containers for the packaging of parenteral products due to their optical clarity, general inertness, and hermetic properties, but under certain circumstances, they can pose safety concerns. Most of these issues are related to the potential formation of glass particulates through delamination or precipitation, resulting from the chemical interaction between the drug product and the inner surface of the glass vial. Hence, it is imperative for pharmaceutical companies to conduct product-vial compatibility studies to determine the appropriate packaging/container closure system. To support this development activity, scientists need to develop analytical methods to detect subvisible glass particulates in parenteral products, along with the appropriate positive controls, to facilitate detection and identification. This paper outlines the utilization of coaxial/episcopic and oblique illumination microscopy, combined with spectroscopic techniques, to detect thin glass particulates generated from a modified procedure. It also showcases the importance of angle-dependent lighting in visualizing positive control samples containing thin glass particulates. The analytical microscopy techniques discussed in this paper can assist scientists in selecting suitable container closure systems for developing parenteral products. [ABSTRACT FROM AUTHOR]

The selective and controllable functionalization of unreactive C(sp3)–H bonds under mild conditions is a highly desirable yet challenging goal in both organic synthesis and pharmaceutical industry. Herein, we report an unprecedented visible-light mediated metal- and oxidant-free carbonylation of both benzylic and allylic C–H bonds with H2O. The synergistic combination of an organophotocatalyst 4CzIPN and a thiol enables the transformation of diverse arrays of benzylic and allylic C–H bonds into carbonyls in moderate to excellent yields with good functional group compatibility. Moreover, the oxidation of amines to aldehydes has also been realized by this protocol. Mechanistically, an oxidative radical-polar crossover (ORPC) process affords an alcohol intermediate, which then undergoes another ORPC process to furnish the carbonyl product. [ABSTRACT FROM AUTHOR]

Background: The increasing consumers' demands for natural bioactive compounds can be attributed to the adverse effects of synthetic antioxidants. While Platanus orientalis leaves are considered waste material, they are a rich source of bioactive compounds. Conventional extraction techniques, however, have different drawbacks for the recovery of bioactive compounds. The current study aimed to optimize and evaluate the impact of microwave-assisted extraction (MAE) as an independent variable on bioactive compounds recovery from P. orientalis leaves. Methods: Response surface methodology was employed to optimize the extraction conditions and maximize the quantitative yield of bioactive compounds. Moreover, the influence of the MAE process on antioxidant activity and phenolic compound profile was investigated using spectroscopy and chromatography techniques. Results: The optimal MAE conditions were determined to be 300 W microwave power, 17 min irradiation time, and a solvent-to-sample ratio of 31 v/w. The extract obtained under these optimized conditions showed a higher concentration of valuable phenolic compounds, including rutin, gallic acid, myricetin, and catechin. Conclusion: The leaves of P. orientalis have the potential to be a source of bioactive compounds with significant anti-radical capacity. MAE is a potential modern technique to separate bioactive compounds from P. orientalis leaves, which could find further applications in the food and pharmaceutical industries. [ABSTRACT FROM AUTHOR]

The phenomenon of coagulation and breakage of particles plays a pivotal role in diverse fields. It aids in tracking the development of aerosols and granules in the pharmaceutical sector, coagulation or breakage of droplets in chemical engineering, understanding blood clotting mechanisms in biology, and facilitating cheese production through the action of enzymes within the dairy industry. A significant portion of research in this direction concentrates on coagulation or linear breakage processes. In the case of linear case, bubble particles break down due to inherent stresses or specific conditions of the breakage event. However, in many practical situations, particle division is primarily due to forces exerted during collisions between particles, necessitating an approach that accounts for nonlinear collisional breakage. Despite its critical role in a wide array of engineering and physical operations, the study of this nonlinear fragmentation phenomenon has not been extensively pursued. This article introduces an innovative semi-analytical method that leverages the beyond linear use of equation superposition function to address the nonlinear integro-partial differential model of collisional breakage population balance. This approach is versatile, allowing for the resolution of both linear/nonlinear equations while sidestepping the complexities associated with discretization of domain. To assess the precision of this method, we conduct a thorough convergence analysis. This process utilizes the principle of contractive mapping in the Banach space, a globally recognized strategy for verifying convergence. We explore a variety of kernel parameters associated with collisional kernels, alongside breakage and initial distribution functions, to derive novel iterative solutions. Comparing our findings with those obtained through the finite volume method regarding number density functions and their integral moments, we demonstrate the reliability and accuracy of our approach. The consistency and correctness of our method are further validated by depicting the errors between the exact and approximated solutions in graphical and tabular formats. [ABSTRACT FROM AUTHOR]

In recent years, transdermal drug delivery systems have gained considerable attention for their ability to enhance patient compliance and provide consistent drug release. However, the barrier function of the skin's outermost layer remains the foremost challenge in these systems. As a result, there is a growing interest in the use of ethosomes as a cutting-edge nanocarrier in drug delivery. This review presents the concept and mechanism of action of ethosomes as well as the numerous types and preparation techniques available. It also discusses the significance of characterization methods and how they impact ethosomal properties along with recent advancements and applications in the realm of transdermal drug delivery. Ethosomes exhibit tremendous potential for the pharmaceutical industry, and optimizing preparation methods, performing comprehensive property studies, and exploring their applications are critical areas for future research. [ABSTRACT FROM AUTHOR]