Administrative Agencies Research Articles

Effect of ginger on the quality attributes of pineapple juice during storage

Homemade pineapple juice usually prepared without pasteurization and stored at room temperature could significantly influence the quality of the juice. This study aimed at assessing the effect of ginger (Zingiber officinale Rosc.) on bacteriological, physicochemical and nutritional quality of pasteurized and unpasteurized pineapple juice during storage at ambient temperature (28±2 oC) for 7 days. Unpasteurized; pineapple juice + 10 ml ginger; pineapple juice + 20 ml ginger; pineapple juice + 10 ml ginger; pineapple juice (control) were evaluated. The results obtained showed that total heterotrophic bacterial count, pH, titratable acidity and total soluble solids of the samples treated with ginger were within the range of 2.23-4.60 log10CFU/mL, 4.0-4.9, 0.51-1.86 g/l and 6.9-13.4 % while the corresponding values for the control was 2.0-4.14 log10CFU/mL, 3.5-4.8, 0.63-1.5 g/l, and 9.1-13.2 %, respectively. All the pineapple juice preparations met the National Agency for Food Drug Administration and Control (NAFDAC) requirements. The sample that had the highest vitamin C and ash content was unpasteurized pineapple juice mixed with 30 mL of ginger (7.46 mg/10 mL) and the control which was pasteurized (4.3 %) respectively. Based on the results obtained from this study, pasteurization of pineapple juice as well as addition of ginger to the juice are recommended for the production of a safe product for human consumption

Democratic innovations beyond the deliberative paradigm: a re-conceptualization based on Luhmann’s systems theory

ABSTRACT The current research on deliberative-participatory democratic innovations conducted by state administration agencies exhibits empirical eclecticism and is dominated by a deliberative paradigm. However, this paradigm tends to conflate normative prescription with analytical description. In contrast, this article proposes a comprehensive re-conceptualization of such innovations, drawing from Niklas Luhmann’s systems theory. It outlines the specific problem these innovations address (function), how they operate in tackling this problem (functioning) and the problems they inevitably raise (dysfunctions). In addition, my re-conceptualization retains the possibility to critically compare these (and other) experiments regarding their capability to address emerging challenges within the modern democratic political system.

Presidential Transitions and Interests Group Participation in the Notice and Comment Process

Federal administrative agencies are one of the primary policymaking venues in the United States. One of the core features of U.S. administrative practice is the notice-and-comment process in which agencies solicit, collect, and respond to comments from the public before issuing new regulations. In this paper, we develop a model of commenting based on three motivations—litigation preservation; agency persuasion; and expression—and analyze public comments to determine how features of the political environment, and specifically the president in power, affect the pool of commenters. We focus on the 2017 presidential transition, when there was both a change in Presidents and the party in control of the White House. We find that there were greater differences in the pool of commenters between administrations than within administrations and that interest groups tended to participate more when they were more closely associated with the party in power. Our findings support the view that many commenters use the public comment process for persuasive purposes, and not only to preserve litigation opportunities or for purely expressive reasons.

Targeting KRASG12C in Non-Small-Cell Lung Cancer: Current Standards and Developments.

Among the most common molecular alterations detected in non-small-cell lung cancer (NSCLC) are mutations in Kristen Rat Sarcoma viral oncogene homolog (KRAS). KRAS mutant NSCLC is a heterogenous group of diseases, different from other oncogene-driven tumors in terms of biology and response to therapies. Despite efforts to develop drugs aimed at inhibiting KRAS or its signaling pathways, KRAS had remained undruggable for decades. The discovery of a small pocket in the binding switch II region of KRASG12C has revolutionized the treatment of KRASG12C-mutated NSCLC patients. Sotorasib and adagrasib, direct KRASG12C inhibitors, have been approved by the US Food and Drug Administration (FDA) and other regulatory agencies for patients with previously treated KRASG12C-mutated NSCLC, and these advances have become practice changing. However, first-line treatment in KRASG12C-mutated NSCLC does not differ from NSCLC without actionable driver genomic alterations. Treatment with KRASG12C inhibitors is not curative and patients develop progressive disease, so understanding associated mechanisms of drug resistance is key. New KRASG12C inhibitors and several combination therapy strategies, including with immune checkpoint inhibitors, are being studied in clinical trials. The aim of this review is to explore the clinical impact of KRAS, and outline different treatment approaches, focusing on the novel treatment of KRASG12C-mutated NSCLC.

The safety, quality evaluation, and lot release of COVID-19 vaccines imported and used in Nigeria from march 2021 to march 2022

Coronavirus disease (COVID-19) caused by the Severe Acute Respiratory Syndrome Corona 2 Virus (SARS-COV-2 Virus) was a major global health crisis that resulted in severe illness and death around the globe. The swift development of effective vaccines against the disease to mitigate severe illness and death was one of the greatest public health scientific achievements. Most of these vaccines required cold storage and were exported to many developing countries with resource limitations to verify the quality of these products. The National Agency for Food and Drug Administration and Control (NAFDAC) regulates the quality of vaccines imported into Nigeria. This study provides summaries of data collected and QC measures conducted on all the COVID-19 vaccines imported into Nigeria within 2021–2022. Cold-chain parameters and other data requirements for meeting international standards for assessing the quality of vaccines were conducted in ISO17025-accredited laboratories of the Nigerian FDA. QC tests used to assess the safety of the products included tests for sterility, bacterial endotoxin, abnormal toxicity, pH, Physical appearance, extractable volumes, protein tests, and DNA: protein ratios. The products yielded satisfactory compliance, however, there were unsatisfactory sterility and protein test results for two batches of the samples tested. There are additional non-QC regulatory measures employed by NAFDAC to ensure the safety of the COVID-19 vaccines, including supply chain management. Out of ninety-five batches of different COVID-19 vaccines evaluated, 95.5% passed sterility testing. There is a 100% pass of all the vaccines for the Bacteria Endotoxin Test while an 80% pass was observed for the protein content.

A Review of Analytical Methods for Adeno-Associated Virus Vectors’ Biodistribution and Shedding Studies

Adeno-associated virus (AAV)-based gene therapy (GT) products can effectively deliver transgenes to replace lost or defective genes, providing hope for patients. However, there is limited research on analytical methods for pre-clinical and clinical studies which could impede their development success. During the development of AAV-based GT products, it is crucial to define the biodistribution and shedding profiles following treatment. In this review, we summarize PK studies for the AAV-based GT products approved so far by U.S. Food and Drug Administration and European Medicines Agency. We then comparatively review the analytical methods employed to evaluate AAV vectors’ biodistribution and shedding of approved GT products. We further make recommendations on choice of methodologies for future GT product development based on the study data and the currently available regulatory guidance.

Bridging the organoid translational gap: integrating standardization and micropatterning for drug screening in clinical and pharmaceutical medicine

Abstract Synthetic organ models such as organoids and organ-on-a-chip have been receiving recognition from administrative agencies. Despite the proven success of organoids in predicting drug efficacy on laboratory scales, their translational advances have not fully satisfied the expectations for both clinical implementation and commercial applications. The transition from laboratory settings to clinical applications continues to encounter challenges. Employing engineering methodologies to facilitate the bridging of this gap for organoids represents one of the key directions for future advancement. The main measures to bridge the gap include environmental and phenotypic recapitulation, 3D patterning, matrix engineering, and multi-modality information acquisition and processing. Pilot whole-process clinical/pharmaceutical applications with fast and standardized organoid models will continuously offer convincing frontline optimization clues and driving forces to the organoid community, which is a promising path to translational organoid technologies.

A novel approach to identify priority areas for optimal nutrient management in mixed land-use watersheds through nutrient budget assessment

Excessive nutrient supply in agricultural regions has led to various environmental issues, thereby requiring concentrated management owing to its persistent upward trend. Nutrient budgets (NBs), a vital agricultural environmental indicator, are employed for nutrient management in agricultural areas, using data surveyed by administrative agencies. However, the spatial extent of nutrient data for nutrient budgeting is limited by administrative boundaries according to the surveying organization, posing challenges in interpreting spatial patterns at the watershed level. In this study, a novel approach was developed to identify priority nutrient management areas by applying hot spot spatial analysis to watershed-level NBs, considering hydrological characteristics. This method was applied to approximately 850 subwatersheds across the Republic of Korea, where land cover characteristics are complex. Reassessing nutrient budgets at the watershed scale, accounting for overlapping administrative boundary areas and crop cultivation ratios, indicated similar levels between the two methods. Hot spot analysis revealed that watersheds with elevated NBs mirrored the spatial patterns of livestock excreta and cropland. The spatial distribution characteristics of watersheds with high nutrient levels in rivers corresponded with the concentration characteristics of industrial and commercial areas. Therefore, applying watershed-level NBs based on land cover ratios that consider nutrient input characteristics in agricultural regions is deemed appropriate for selecting priority nutrient management areas. Collectively, this study presents a method for selecting nutrient management priority areas by simultaneously considering the spatial characteristics of various environmental factors, such as land cover, livestock excreta, river water quality, and land area-based watershed-specific NBs. The proposed approach, considering mixed land cover characteristics, is anticipated to be valuable for selecting priority management areas in watersheds with diverse pollution sources. Future research is needed to explore nutrient budgets within watersheds, the influence of land use on pollution sources, and their correlation with water quality.

Ethanol Content of Medications and Its Effect on Blood Alcohol Concentration in Pediatric Patients.

Ethanol is a common excipient used in liquid medications to enhance solubility and inhibit -bacterial growth. While the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have released guidance for how much ethanol is acceptable in medicines, many medications contain more than the recommended amount. The objective of this study was to determine what effect these medications would have on blood alcohol concentration (BAC) for pediatric patients, defined as those medications that would increase the BAC by ≥2.5 mg/dL. A list of medications dispensed to pediatric patients from a single hospital over a period of 4 months was obtained. The package inserts of these medications were reviewed to determine ethanol content. Typical doses were used to determine the amount of ethanol pediatric patients weighing 10, 20, and 40 kg would receive. The theoretical BAC was then calculated for each medication containing ethanol. Seven hundred ninety-six medications were dispensed for pediatric patients during the study period, of which 33 contained ethanol. Seven medications would be projected to increase the BAC above 2.5 mg/dL with a normal pediatric dose. While most medications do not contain ethanol, we found 7 that contained enough ethanol to potentially raise the BAC above 2.5 mg/dL. Health care practitioners should consider the ethanol content of medications prior to recommending them in children and when assessing overdoses.

Entry-Level Export Strategies in Developing African Countries

Considering Nigeria as an economically and demographically viable target market, this study examined entry-level export strategies that could facilitate the expansion of foreign firms to the Nigerian market. It was necessitated by the intricacies experienced by foreign companies in obtaining credible information about the Nigerian market for internationalization decision-making. The study adopted a narrative literature review design, relying on experiential insights and secondary data obtained from government and industrial sources in Nigeria to obtain the information presented in the investigation. An in-depth content analysis method was used to analyze the secondary data obtained for the study. From its findings, it was revealed that Nigeria is a profoundly viable export destination for a wide variety of foreign products including consumer electronics, ICT accessories, fashion, cosmetics and smartphone accessories. Nevertheless, the country’s volatile economic condition poses substantial risks for foreign companies in terms of foreign currency fluctuations; but using an export strategy, these risks can be considerably mitigated. This indicates the need for careful and deliberate export planning before entry into Nigeria to ensure that exporters familiarize themselves with information and knowledge of the workings of the Nigerian market. To this end, we recommend that intending export companies should carefully select suitable market segments they can consistently serve; they should also ensure to obtain all necessary certifications and permits from key agencies like the Nigeria Customs Service (NCS), National Agency for Food and Drug Administration and Control (NAFDAC), and Standards Organization of Nigeria (SON) to ensure smooth operations; and in terms of export entry option, we recommend a hybrid approach (direct and indirect exportation), which avails companies the opportunity of using local expertise and network to achieve effective distribution while maintaining strong control over their products.

Contemporary hypolipemic therapy: possibilities of novel hypolipemic drugs in correction of lipid metabolism disorders. Review

Dyslipidemia plays a role of significant risk factor for development and progression of cardiovascular diseases. Today several classes of hypolipemic drugs with evidenced effectiveness are used. But some patients don’t tolerate medicines with high efficacy or can’t achieve the targeted blood lipid profile levels even in case of the use of maximal doses or combined therapy. This necessitates the creation of new hypolipidemic agents.
 The review is devoted to discussion of new directions of influence on impaired lipid metabolism through creation of new classes of hypolipemic drugs with some perspectives of effective correction of lipid factors of cardiovascular risk (CVR) in cases of impossibility to achieve the targeted levels of low‑density lipoprotein cholesterol (LDL‑C) or there is a residual CVR caused by elevated serum triglyceride (TG) levels and/or low levels of high‑density lipoprotein cholesterol (HDL‑C).
 Among the novel drugs for hypercholesterolemia (HCE) correction, considerations are given for some mechanisms of action and efficacy of application of proprotein convertase subtilisin‑kexine type 9 (PCSK9) inhibitors as well as bempedoic acid (adenosine triphosphate citrate lyase inhibitor) and inclisiran, a small synthesized interfering ribonucleic acid (RNA) with its ability to blockade genes‑regulators of hepatic PCSK9 activity. The novel agents for hypertriglyceridemia correction, discussed in the review, include icosapent ethyl (a high purified and firm ester of ethyl‑eicosapentoenic acid), pemafibrate (the first selective modulator of α‑receptors activated by peroxisome proliferator), apolipoprotein C‑III (ApoC‑III) inhibitors (volasenorsen, olesarsen), mipomersen (antisense nucleotide for matrix RNA of apolipoprotein B‑100), lomitapide (inhibitor of microsomal TG transfer protein) and inhibitors of angiopoietin‑like protein 3 (ANGPTL3) (evinacumab, vupanorsen). Among the new approaches to HDL‑C elevation an attention is paid to the experimental and clinical investigations of recombinant HDL, agents with recombinant lecithin‑cholesterol‑acyl‑transferase (LCAT), and apolipoprotein A‑I (ApoA‑I) mimetic peptides. For the lowering of blood lipoprotein(a) (LP(a)) level the possibilities of pelacarsen, an antisense oligonucleotide for matrix RNA of apolipoprotein(a) (apo(a)) contained in LP(a) molecule and olpasiran, a small interfering RNA for LP(a) molecule inhibited apo(a) synthesis are uncovered. A high probability of clinical application in the nearest future will have novel drugs approved by US Food and Drug Administration (FDA) and European Medicines Agency (EMA) such as bempedoic acid and inclisiran for HCE correction as well as lomitapide for the treatment of familial HCE.

대행 관련 법제도 분석 및 개선방안

The agency system of administrative affairs has many provisions under the current law, but there is no unified definition provision. Therefore, in order to prevent confusion in law enforcement and to improve the efficiency of administration through the agency of administrative affairs, a legal reorganization is required. This study attempted to systematize the legal principles of the agency system through comparison with adjacent concepts and analysis of related precedents, to identify a general principles through investigation and categorizing of the current law that codified the agency. Chapter 2 analyzes legal theories and precedents related to the agency system. In the case of an agency, it is distinguished from delegation or consignment to which authority and responsibility are transferred in that the agency is given virtually independent administrative authority, but the authority is not legally transferred, and it is also different from an administrative assistant who technically executes administrative affairs independently according to the direction of the administrative agency. The agency system is characterized by the reservation of its authority and responsibility because all legal effects are bound to the agency and the agency is not specified as an agent. Regarding agency, the Supreme Court cases judge the term agency based on the meaning of the actual use of the term agency, such as denying or affirming the effect of disposition in the name of the agent by grasping the legal nature of the agency in detail. In the case of the Constitutional Court, there are many judgments on whether the agency system related to freedom of occupation is unconstitutional. In Chapter 3, provisions related to agency are categorized based on the results of an investigation of the current laws. It is classified into a type in which the state or local government, which is the agency to act, entrusts administrative affairs to the private sector based on laws and regulations, a form in which an administrative agency entrusts administrative affairs to another administrative agency, and a case in which the administrative agency entrusts the authority and duties in the event of an vacancy of a job performer. Examining based on these types of work, there are limitations that it is difficult to find the general principles of the agency system that apply to all the provisions under the current law that stipulate agency. In addition, there are many articles that stipulate ‘entrustment or agency’, so it seems desirable to reorganize the legal system in a parallel way that legalizes issues specific to administrative agency and reorganizes agency articles used in the same sense as entrustment or delegation. If a plan to improve the agency system is presented based on these implications, it should prioritize creating a general rule on the agency's general affairs, and making preliminary guidelines on the permission, basis, reservation of authority and responsibility of the agency. It needs to improve legal consistency by preparing regulatory provisions for the agency, making it a general provision that the administrative agency has the authority to direct and supervise administrative affairs. It is necessary to reserve the authority to take measures such as ordering or correcting the agency's handling of administrative affairs, and to codify where external responsibility may arise to third parties due to the suspension or cancellation of the agency. At the same time, it is necessary to amend the provisions under the individual laws that stipulate agency into entrustment, delegation, and acting on duty to meet specific legal characteristics.

드론 교육과 안전에 관한 연구

The purpose of this study is to select the contents of Drone Act as the subject of research and to examine the appropriateness of education and safety regulations. For this purpose, the application form of the drone education field was examined based on the relevant regulations of the Drone Act and the Aviation Safety Act. In addition, interviews were conducted with school faculty and staff and drone education instructors. The research results derived from this study are as follows. First, school faculty recognize the necessity and importance of drone education. However, there are many restrictions on the implementation and expansion of education due to the lack of drone-related certified teachers. Therefore, it is necessary to support faculty to obtain drone-related certificates or participate in training programs such as safety education. Second, in order for drone programs to proceed safely and effectively in the educational field, it is necessary to supplement the effective budget system for external experts (drone instructors, evaluators, etc.) and prepare appropriate laws for insurance against safety accidents. Therefore, administrative agencies need to reorganize or establish new laws and regulations necessary for safe and effective drone education with the Ministry of Education or regional education support offices. In addition, regulations and budget systems that allow external experts as well as school faculty members to participate in educational programs should be reviewed and prepared to prevent the occurrence of underprivileged areas.

The role of regulatory authorities in the regulation and control of herbal medicines: A case study of NAFDAC

This paper examines the pivotal role of regulatory authorities in governing and overseeing the production, distribution, and consumption of herbal medicines, with a specific focus on the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria. Through an extensive literature review and analysis of regulatory frameworks, this study elucidates the challenges and opportunities associated with regulating herbal medicines within a rapidly evolving healthcare landscape. It investigates NAFDAC's mandate, regulatory processes, and enforcement mechanisms in ensuring the safety, efficacy, and quality of herbal products. Additionally, this paper explores case studies and regulatory interventions implemented by NAFDAC to address issues such as adulteration, contamination, and mislabeling of herbal medicines. By critically assessing NAFDAC's role and performance in regulating herbal medicines, this study provides valuable insights into the complexities of herbal medicine regulation and underscores the importance of robust regulatory oversight in safeguarding public health and promoting rational herbal medicine use.

Therapeutic applications of carbohydrate-based compounds: a sweet solution for medical advancement.

Carbohydrates, one of the most abundant biomolecules found in nature, have been seen traditionally as a dietary component of foods. Recent findings, however, have unveiledtheir medicinal potential in the form of carbohydrates-derived drugs. Their remarkable structural diversity, high optical purity, bioavailability, low toxicity and the presence of multiple functional groups have positioned them as a valuable scaffold and an exciting frontier in contemporary therapeutics. At present, more than 170 carbohydrates-based therapeutics have been granted approval by varying regulatory agencies such as United States Food and Drug Administration (FDA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), Chinese National Medical Products Administration (NMPA), and the European Medicines Agency (EMA). This article exploresan overview of the fascinating potential and impact of carbohydrate-derived compounds as pharmacological agents and drug delivery vehicles.

원자력규제기관활동이 방사선작업종사자의 원자력규제정책 만족도에 미치는 매개효과(mediation effect) 분석

In order to prevent radiation-related disasters for radiation workers, the higher the average radiation exposure dose for each industry, the stronger the regulatory level of nuclear and radiation safety regulatory agencies is for its purpose and relevance. Therefore, nuclear regulatory agencies must apply radiation safety-related licensing and technical standards for nuclear power facilities differently for each type of nuclear business operator depending on the degree of risk of exposure to radiation. From the perspective of a nuclear regulatory agency with limited administrative and financial resources, this study was conducted to efficiently prioritize the regulated sectors of nuclear power operators and promote scientification of regulatory administration by incorporating evidence-based administration. Using the results of the 「2021 Nuclear Safety Survey」 conducted on 2,000 radiation workers, we investigated how radiation workers' satisfaction with nuclear regulation policy changes depending on the activities of nuclear regulatory agencies between independent, mediating, and dependent variables. Direct effects and indirect effects were measured and tested. Four exogenous factors, including the accident response human management system (ERHMS), accident response material management system (ERMMS), in-house safety culture (CISC), and recurrence prevention safety education system (RPSES) for radiation workers subject to nuclear regulation by the nuclear regulatory administrative agency. The regulatory agency activity satisfaction (RAAS), which is a mediating factor, and the endogenous factor 'nuclear energy and radiation safety' regulatory policy satisfaction (NRPS) were set as independent variables, mediators, and dependent variables, respectively. We examined whether the reliability, validity, and correlation between survey items and measurement variables were significant through reliability analysis, correlation analysis, and factor analysis. As a result of multiple regression analysis and structural equation modeling (SEM) mediation effect analysis, the 'activities of regulatory agencies' regarding the accident response human and material management system, in-house safety culture, and accident recurrence prevention education system are related to the nuclear and radiation safety regulatory policy of radiation workers. It was confirmed that it was an influential factor that made a significant difference in satisfaction. When comparing the sizes of standardization coefficients, the sizes of factors affecting satisfaction with nuclear regulation policy are: in-house safety culture (β=0.395), accident response human management system (β=0.080), accident response material management system (β=0.077), Relapse prevention safety education system (β=0.042) appeared in that order. The implications of this study are that the direction of the nuclear safety regulation policy of regulatory agencies that carry out nuclear regulation administration with limited administrative and financial resources is related to the in-house safety culture (CISC) and accident response human management system of nuclear power operators to prevent nuclear and radiation safety accidents. It can be said that it has been verified through quantitative research that strengthening nuclear safety through reinforcement is more effective and efficient

Level of aflatoxins in dairy feeds, poultry feeds, and feed ingredients produced by feed factories in Addis Ababa, Ethiopia.

Aflatoxins are one of the major factors that affect the quality and safety of feeds. They can be transferred into livestock through contaminated feed and then onto humans via animal sources of food such as milk, meat, and eggs. The objective of this study was to detect and quantify the level of aflatoxins (B1, B2, G1, G2, and total aflatoxin) in dairy feeds, poultry (layer and broiler) feeds, and feed ingredients produced in Addis Ababa. A total of 42 feeds and feed ingredients consisting of dairy feeds (n = 5), poultry broiler feeds (n = 6), layer feeds (n = 6), and feed ingredients (n = 25) were collected from feed factories in the city and analyzed in fresh weigh basis. The aflatoxins were analyzed using high-performance liquid chromatography after clean-up with immunoaffinity columns. Aflatoxin B1 levels in feeds ranged from 51.66 to 370.51µg/kg in dairy cattle feed, from 1.45 to 139.51µg/kg in poultry layer feed, and from 16.49 to 148.86µg/kg in broiler feed. Aflatoxin B1 levels in maize ranged from 2.64 to 46.74µg/kg and in Niger seed cake from 110.93 to 438.86µg/kg. Aflatoxin B1 levels in wheat bran, wheat middling, and soybean were below 5µg/kg. 100% of dairy feeds, 67% of poultry layer, 67% of broiler feeds, and 24% of ingredients contained aflatoxin in levels higher than the maximum tolerable limit set by the US Food and Drug Administration and Ethiopian Standard Agency. This shows the need for strong regulatory monitoring and better feed management practices to prevent consumers of animal-source foods from significant health impacts associated with aflatoxins.

Amend: an integrated platform of retracted papers and concerned papers

Abstract Purpose The notable increase in retraction papers has attracted considerable attention from diverse stakeholders. Various sources are now offering information related to research integrity, including concerns voiced on social media, disclosed lists of paper mills, and retraction notices accessible through journal websites. However, despite the availability of such resources, there remains a lack of a unified platform to consolidate this information, thereby hindering efficient searching and cross-referencing. Thus, it is imperative to develop a comprehensive platform for retracted papers and related concerns. This article aims to introduce “Amend,” a platform designed to integrate information on research integrity from diverse sources. Design/methodology/approach The Amend platform consolidates concerns and lists of problematic articles sourced from social media platforms (e.g., PubPeer, For Better Science), retraction notices from journal websites, and citation databases (e.g., Web of Science, CrossRef). Moreover, Amend includes investigation and punishment announcements released by administrative agencies (e.g., NSFC, MOE, MOST, CAS). Each related paper is marked and can be traced back to its information source via a provided link. Furthermore, the Amend database incorporates various attributes of retracted articles, including citation topics, funding details, open access status, and more. The reasons for retraction are identified and classified as either academic misconduct or honest errors, with detailed subcategories provided for further clarity. Findings Within the Amend platform, a total of 32,515 retracted papers indexed in SCI, SSCI, and ESCI between 1980 and 2023 were identified. Of these, 26,620 (81.87%) were associated with academic misconduct. The retraction rate stands at 6.64 per 10,000 articles. Notably, the retraction rate for non-gold open access articles significantly differs from that for gold open access articles, with this disparity progressively widening over the years. Furthermore, the reasons for retractions have shifted from traditional individual behaviors like falsification, fabrication, plagiarism, and duplication to more organized large-scale fraudulent practices, including Paper Mills, Fake Peer-review, and Artificial Intelligence Generated Content (AIGC). Research limitations The Amend platform may not fully capture all retracted and concerning papers, thereby impacting its comprehensiveness. Additionally, inaccuracies in retraction notices may lead to errors in tagged reasons. Practical implications Amend provides an integrated platform for stakeholders to enhance monitoring, analysis, and research on academic misconduct issues. Ultimately, the Amend database can contribute to upholding scientific integrity. Originality/value This study introduces a globally integrated platform for retracted and concerning papers, along with a preliminary analysis of the evolutionary trends in retracted papers.

'Totality of Evidence' Approach in the Development of GP2017, an Approved Adalimumab Biosimilar.

Hyrimoz®, (GP2017 [SDZ-ADL]), is a biosimilar to Humira® (REF-ADL). SDZ-ADL was approved in 2018 by both the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) for the indications of REF-ADL not protected by orphan exclusivity. In 2023, the US FDA and EMA also approved a citrate-free high-concentration formulation (HCF) of SDZ-ADL. Approval of SDZ-ADL was based on data gathered using the US FDA, EMA and World Health Organization (WHO)-recommended step-wise Totality of Evidence approach. This approach is a robust dataset confirming high confidence in analytical, functional, pharmacokinetic (PK) and clinical biosimilarity between the biosimilar and reference medicine determined through analytical and clinical investigation. Evidence supporting the biosimilarity of SDZ-ADL and REF-ADL was reported at each stage of investigation. Comprehensive comparative analytical and functional assessments demonstrated that SDZ-ADL was analytically indistinguishable from REF-ADL in required critical quality attributes, including receptor binding. Phase I clinical data showed PK similarity of SDZ-ADL and REF-ADL in healthy volunteers, with similar safety, tolerability and immunogenicity profiles. Phase III confirmatory efficacy and safety studies, ADACCESS (included in US/EU dossiers) and ADMYRA (separate to US/EU dossiers), both confirmed that SDZ-ADL's efficacy, safety, and immunogenicity matched REF-ADL in all patient groups with no clinically meaningful differences. More recently, this data package was the basis for a citrate-free HCF of SDZ-ADL to be developed, and its PK, safety and immunogenicity were confirmed against the initially approved formulation of SDZ-ADL. Overall, the Totality of Evidence provided for biosimilar adalimumab, SDZ-ADL, confirmed the analytical, functional and clinical similarity of SDZ-ADL to REF-ADL, supporting its regulatory approval and providing a data bridge with which to evaluate and support the approval of citrate-free HCF SDZ-ADL for clinical use.

US Supreme Court Limits on the Power of US Health Agencies

This Viewpoint describes how the overturning of Chevron deference would shift the ability to make policy decisions about public health and the environment from administrative agencies to the courts.