Regulatory Purpose Research Articles

Modelling pesticide concentrations in Japanese paddy fields using the RICEWQ model

Increasing concerns about plant protection products in surface waters have highlighted the importance of pesticide monitoring and modelling, both nowadays integral components of the pesticide registration process. The Rice Water Quality (RICEWQ) model predicts the fate and transport of pesticides under various paddy environmental conditions. The model has been used widely for regulatory purpose in the U.S., while its use in Europe has been limited to regulatory submissions, despite multiple recommendations to adopt RICEWQ as a high tier assessment model for regulatory purposes. The applicability of the RICEWQ model under Japanese agricultural conditions remains unexplored. This study leverages field experimental data to evaluate the RICEWQ model's capability to simulate daily concentrations of two herbicides, mefenacet and pretilachlor, in paddy water and paddy soil in Japan.The RICEWQ model provided a reasonable level of performance for predicting the fate and transport of the two herbicides by ensuring that the simulated daily water balance corresponded with field observations and with minor pesticide-specific calibration. To further improve the performance of the simulations, we implemented a straightforward calibration framework. Calibrating the RICEWQ model improved the accuracy of all simulations; for both herbicides and in both paddy water and paddy soil compartments, the lowest Nash-Sutcliffe efficiency achieved was 0.725, demonstrating excellent performance. However, the RICEWQ model consistently underestimated the peak concentrations of herbicides in paddy water within the first three days of simulation. Simulation results suggested that approximately 50 % of the total applied herbicide was lost from the paddy system. Increasing the duration of the water holding period after pesticide application or increasing the storage capacity of the rice field via excess water storage depth management has the potential to reduce greatly herbicide loss to below 10 % of the total applied herbicide.

RESEARCH & DEVELOPMENT OF P2O5 DETERMINATION METHOD IN PHOSPHATE FERTILIZERS AND ITS VALIDATION

The validation of chemical measurement for Phosphorus determination in fertilizers followed a chain of experimental procedures to ascertain the performance characteristic (PC), connecting Precision, accuracy, reproducibility, recovery, linearity, limit of detection and of quantification. Performance characteristics are accomplished to ensure that analytical method fits the purpose of particular testing. This method was conducted in three stages those were preparation, testing and data processing. The standard test method for determination of P2O5 content in fertilizers used for regulatory purpose is somewhat lengthy and time taking. A modification was done to the standard method to create a more efficient approach that meets validation criteria and is suitable for analyzing advisory fertilizer samples. During the year 2023-24, comprehensive research and development activity were carried out at Soil and Water Testing Laboratory (SWTL) for Research, Faisalabad and analytical data was generated. The obtained results were processed statistically and compared with the acceptance requirements. The coefficient of determination (R2), precision and accuracy/recovery percentage respectively were 0.9996, 0.3-1.10% and 98.01-102.34%, while LOD and LOQ were 0.84 and 2.25%. Based on the results the study concluded that the modified test method applied to determine P2O5was appropriate for its intended use based on the acceptance criteria of performance characteristics set forth in the validation protocol and can be applied as routine method at laboratory.

Contemporary Practice and Considerations for Real-World Data Source Identification and Feasibility Assessment.

There has been rapid growth in the variety and number of real-world data (RWD) sources, as well as the number of regulatory documents that provide guidance for assessing the suitability of RWD sources for pharmacoepidemiology studies. This study aims to assess differences in RWD guidance and variability in current practice for identifying and assessing RWD for studies with regulatory purpose. Key criteria for feasibility assessment were mapped against relevant regulatory guidance documents across US, EU, and Asia-Pacific regions. An online survey was designed and deployed to International Society for Pharmacoepidemiology members to understand current practice. Findings were summarized and used to inform key considerations and recommendations. Eleven RWD guidance documents were identified and mapped against 14 RWD assessment criteria. Variability was seen across these documents in guidance for these criteria. Between December 2022 and January 2023, 37 survey respondents reported having used RWD for post-marketing commitments (34, 92%) and/or background epidemiology (28, 76%). RWD were mostly identified through literature (33, 89%) and data landscaping (26, 70%); guidance documents referenced included: Food and Drug Administration (20, 54%), European Network for Centres for Pharmacoepidemiology and Pharmacovigilance (17, 46%), European Medical Agency (16, 43%), and Structured Process to Identify Fit-For-Purpose Data (11, 30%). Challenges for conducting feasibility assessments included RWD accessibility, ability to complete validation, and RWD provider responsiveness. Existing guidelines are used extensively by researchers, but key criteria for RWD identification and feasibility assessment are not reflected consistently and challenges remain. Recommendations have been made reflecting study findings.

Reconceptualizing Norm Conflict in International Law

Abstract This article reconceptualizes norm conflict in international law by uncovering the experiential dimension of its definition and the intentional dimension of its resolution that has been missing from traditional accounts. The article locates the basis of recognizing norm conflict in the experienced sense of incompatibility between norms in view of their contexts rather than in the predesignated constellation of norms with contrary or contradictory functions according to their texts. Concomitantly, it argues that the justification for using certain legal techniques to resolve norm conflicts lies in the intended relationship deducible only between those norms that share the same regulatory purpose rather than between norms merely applying to the same factual situation. This reconceptualization generates a new typology of norm conflicts in light of the norms’ end goals and the means they provide to achieve them: “Ends Conflict”, “Means Conflict”, and “Unexperienced Conflict”, and suggests apposite ways to tackle them.

Making way for the implementation of automated bee counters in regulatory risk assessment

AbstractMeasuring adverse effects on honey bees and their colonies requires a suitable methodology. For example, due to the large number of bees in a hive and the foraging activity, measuring the mortality of individuals is a difficult task that has not yet been adequately addressed. Knowing the natural daily mortality rate of a bee colony would be of great benefit in assessing whether and to what extent external influences and stress factors affect mortality. More precise mortality data could in turn help refining specific protection goals for regulatory purpose. The European Food Safety Authority recently published a document that estimated such mortality rates based on a systematic literature review, but none of these rates were assessed from continuous monitoring of colonies. Currently, bee mortality is routinely evaluated with various types of dead bee traps that prevent deceased bees from being removed from the colony. Both the literature review and the dead bee traps are relevant to regulatory risk assessment, but in our opinion are not describing the total mortality. Bee counters capable of precisely determining daily loss rates meet the above points and combine them with generating automated and continuous monitoring data. Lately, the field has gained a lot of importance in research and technological advances offer new possibilities in regulatory risk assessment. We will highlight these possibilities and discuss their future application in practice.

ЕКОСИСТЕМНІ ПЛАТЕЖІ ТА ЗБЕРЕЖЕННЯ ЛІСОВИХ ЕКОСИСТЕМ УКРАЇНИ: ЗАКОРДОННИЙ ДОСВІД ТА РИНКОВЕ ЦІНОУТВОРЕННЯ

Environmental issues are too important for the modern world, especially for Ukraine. This topic, despite its relevance, is far from complete. One of the most effective methods of solving these problems is environmental taxation, which makes it possible to introduce regulatory levers of influence on consumers of Natural Resources. Different countries have developed their own approaches to the implementation of tax methods in the mechanism of environmental relations between the state and its counterparties. At the same time, other alternative schemes of these relationships are being introduced. Environmental tax rates in Ukraine lag behind European ones (which is an additional, too influential reason for slowing down in solving environmental problems), and given the European choice of Ukraine, it is relevant to review the current environmental tax rates. This is exactly the goal set in this study. The economic interests of the state and its counterparty consist in determining the amount of ecosystem payments for natural resources, the essence of which is their intended purpose ‒ the preservation, reproduction or restoration of ecosystems, their potential and functions. The authors prove that the current procedure for determining the cost of natural resources through their prime cost is fundamentally wrong and erroneous in its essence, since it does not meet their regulatory purpose. The fundamental reform of the sphere of environmental taxation should take into account: first, the presence of state ownership of Natural Resources in Ukraine; second, the definition of environmental payments as the cost of ecosystem services provided by the relevant ecosystems; third, the need to introduce market elements in the pricing system for these services. Using the example of forest resources, the author's own approach is justified and our own methodology for determining ecosystem payments as the cost of ecosystem services provided by these resources to their consumers is proposed. The cost of ecosystem services for forest ecosystems consists of the cost of assimilation services (absorption of harmful substances by forest ecosystems – carbon dioxide) and the cost of oxygen-producing services (generation of oxygen by them). This ensures that not only and not so much the level of cost of Natural Resources is taken into account, but also, importantly, the use value of ecosystem services provided to consumers by ecosystems. However, the cost of Ecosystem Services determined in this way should be considered as the minimum allowable (basic) level of their price. In the future, to respond to the ratio of supply and demand in the ecosystem services market, it is proposed to apply additional elements of the tender pricing procedure, which brings the process of estimating the cost of these services closer to fairer pricing. The authors believe that the mechanism of tender adjustment, provided that the auction price increases above the minimum allowable (basic) level, is a kind of tender protection of the state's interests in establishing these payments.

An Approach to Assessing the Influence of Environmental and Occupational Cancer Hazard Identification on Policy Decision-Making.

Cancer hazard identification is critical to informing decisions on preventive actions. However, the influence of cancer hazard assessments on the creation of health-protective regulations is poorly understood. Although prior studies have measured the health and economic benefits of regulatory actions in general, we are not aware of efforts to explicitly study the influence of cancer hazard identification on policy decisions in the United States. In this commentary, we present an approach to examine whether formal identification of a substance as a human carcinogen may prompt a regulatory action to reduce exposure to carcinogens and enhance public health. Further, we discuss the broader implications of cancer hazard identification on policy decision-making, including identifying gaps and providing recommendations. Using the Report on Carcinogens (RoC) as a test case, we systematically searched U.S. federal and state databases for notices of regulations mentioning the RoC from 1995 to 2023. For each regulation, we extracted information on the carcinogen(s) regulated, the regulatory agency, the regulatory purpose, the economic sector exposure sources, and the analyzed public health benefits and costs. We created a publicly available, web-based interactive tool to visualize the data. U.S. regulatory agencies have been using cancer hazard evaluations, such as the RoC, for decades to inform public health policy actions to prevent or mitigate cancer risks. Specifically, nonregulatory cancer hazard assessments have been used to prioritize chemical evaluations, support regulatory-based assessments, and trigger regulatory action. Our approach showed that assessing the influence of cancer hazard identification on science-based public health policies is feasible, informative, and needed, and our study is a first step in this direction. We recommend expanding this approach to other cancer and noncancer hazard assessments to ultimately inform our understanding of the influence of hazard classifications on policymaking. https://doi.org/10.1289/EHP12681.

The precarity of the police powers doctrine in investment arbitration: Rockhopper v Italy

Abstract This article analyses the reasoning of the ICSID tribunal in Rockhopper v Italy with respect to the police powers doctrine. It contends that, in upholding the investors’ claim that the Italian government had unlawfully expropriated their investment in an oil and gas field off the Italian coast by passing a law banning hydrocarbon exploitation and refusing their application for a production permit on that basis, the Tribunal approached the police powers doctrine in an insufficiently clear and rigorous way. First, the Tribunal’s reasons were scant and lacked any articulation of the content of the doctrine or engagement with the extensive body of relevant arbitral jurisprudence and scholarship, making it difficult to comprehend how the doctrine was understood and why it was rejected. Secondly, the Tribunal’s assessment of the validity of Italy’s regulatory purpose, being the only aspect of the doctrine with which it engaged, lacked careful engagement with the evidence. As a result of these shortcomings, the Tribunal’s reasons lend a precarity to the police powers doctrine which belies its relatively settled status in investor-state arbitration and reveals the need for greater rigour and lucidity in its future application.

Quality Standards and Pharmacological Interventions of Natural Oils: Current Scenario and Future Perspectives.

Medicinal plants are rich sources of natural oils such as essential and fixed oils used traditionally for nutritive as well as medicinal purposes. Most of the traditional formulations or phytopharmaceutical formulations contain oil as the main ingredient due to their own therapeutic applications and thus mitigating several pathogeneses such as fungal/bacterial/viral infection, gout, psoriasis, analgesic, antioxidant, skin infection, etc. Due to the lack of quality standards and progressive adulteration in the natural oils, their therapeutic efficacy is continuously deteriorated. To develop quality standards and validate scientific aspects on essential oils, several chromatographic and spectroscopic techniques such as HPTLC, HPLC, NMR, LC-MS, and GC-MS have been termed as the choices of techniques for better exploration of metabolites, hence sustaining the authenticity of the essential oils. In this review, chemical profiling and quality control aspects of essential or fixed oils have been explored from previously reported literature in reputed journals. Methods of chemical profiling, possible identified metabolites in essential oils, and their therapeutic applications have been described. The outcome of the review reveals that GC-MS/MS, LC-MS/MS, and NMR-based chromatographic and spectroscopic techniques are the most liable, economic, precise, and accurate techniques for determining the spuriousness or adulteration of oils based on their qualitative and quantitative chemical profiling studies. This review occupies the extensive information about the quality standards of several oils obtained from natural sources for their regulatory aspects via providing the detailed methods used in chemoprofiling techniques. Hence, this review helps researchers in further therapeutic exploration as well as quality-based standardization for their regulatory purpose.

Exploration of a comprehensive versus a regulatory-oriented modeling framework for field pesticide transport assessment

Numerous computer models have been developed for simulating pesticide fate and transport. It is usually hard to choose which model is the best for a particular research or regulatory purpose. Currently, the PRZM (Pesticide Root Zone Model) model is widely used for regulatory purposes regarding runoff and erosion. However, it simplifies many hydrological processes and management practices which affect pesticide fate simulations. In this study, the APEX (Agricultural Policy / Environmental eXtender model) model, which is more comprehensive and may provide a more realistic representation of pesticide fate, was compared with the PRZM model regarding methods and capabilities of characterizing hydrology, management, and pesticide transport. Four case studies were used to compare the performances of the two models for simulating surface runoff, sediment yield, pesticide in runoff, and pesticide in sediment. Results showed that the APEX model performed better than the PRZM model for simulating surface runoff and sediment yield, and performed similarly to the PRZM model for simulating pesticide loads in runoff and erosion. Both models have limitations for capturing the runoff events caused by high intensity rainfall. APEX is superior to PRZM in simulating detailed management operations, considering more hydrological processes, and achieving spatially distributed simulation, but it requires a higher number of inputs and user-selected parameters compared to PRZM. With further validations of the capabilities of APEX in pesticide modeling and the development of web-based platforms to facilitate the set up and use of comprehensive models, a more accurate and reliable pesticide assessment scheme is anticipated by using comprehensive models like APEX.

RegTech and creating public value: opportunities and challenges

Regulatory technology (RegTech) has its origins in private sector applications of information technology in pursuit of more efficient compliance with government regulations. Initially, the term “RegTech” referred to either the technical solutions intended to aid financial service providers in managing regulatory issues or to the companies and organizations that develop and deliver such solutions. Increasingly, regulatory experts are stretching the term’s coverage to include efforts by governments to harness technical solutions in pursuit of more efficient targeting and conduct of regulatory monitoring and enforcement. Whether deployed within the private or public sectors, RegTech holds significant potential to improve regulatory compliance, reduce compliance costs, and improve the speed and accuracy with which known harms can be addressed and emerging risks can be identified. Here, we focus on the potential for RegTech to support the creation of public value. We suggest public value is most likely to be realized when governments (1) keep focused on regulatory purpose and effective design and (2) build effective collaboration with RegTech providers and regulated entities.

A Simple, Precise, and Sensitive RP-HPLC Method for Quantification of Teneligliptin Hydrobromide and Metformin Hydrochloride: Development and Validation

Simple, rapid, sensitive, robust, and validated reverse phase- high-performance liquid chromatography RP_(HPLC) was developed for the quantification of anti-diabetic drugs Teneligliptin hydrobromide (TH) and Metformin hydrochloride (MH) in bulk and in formulation. The RP-HPLC method was developed using an HPLC system with a PDA detector. A simple, accurate and cost-effective gradient approach is used by using C18 Inertsil ODS (150×4.6)mm, 5µ. A method was developed and validated as per ICH Q2 (R1) guideline. The efficient separation of both drugs was achieved using an optimised solvent mixture of Buffer: ACN (85:15% v/v) and Methanol: ACN (50:50% v/v) used as a gradient mobile phase, during this experiments flow rate was maintained 0.8 ml/min and at the end the detection of peak carried out by PDA detector at wavelength 249nm. The method has been validated for TH and MH for a range of 16-64μg/ml and 400 - 1600μg/ml with regression coefficient (r2) was 1 and 0.9979 respectively. The optimal approach has been validated in accordance with ICH guideline Q2(R1). The results demonstrated that the method’s accuracy (99.89–100.34 percent w/w and 99.91–100.01 percent w / w TH and MH, respectively) and method is precise as percentage of relative standard deviation <2.0. The proposed LC method used as qualitative as well as quantitative applications for simultaneous quantification of Teneligliptin hydrobromide and Metformin hydrochloride in bulk and tablet dosage form and also sufficient to apply regulatory purpose.

Surveillance as information practice

AbstractSurveillance, as a concept and social practice, is inextricably linked to information. It is, at its core, about information extraction and analysis conducted for some regulatory purpose. Yet, information science research only sporadically leverages surveillance studies scholarship, and we see a lack of sustained and focused attention to surveillance as an object of research within the domains of information behavior and social informatics. Surveillance, as a range of contextual and culturally based social practices defined by their connections to information seeking and use, should be framed as information practice—as that term is used within information behavior scholarship. Similarly, manifestations of surveillance in society are frequently perfect examples of information and communications technologies situated within everyday social and organizational structures—the very focus of social informatics research. The technological infrastructures and material artifacts of surveillance practice—surveillance technologies—can also be viewed as information tools. Framing surveillance as information practice and conceptualizing surveillance technologies as socially and contextually situated information tools can provide space for new avenues of research within the information sciences, especially within information disciplines that focus their attention on the social aspects of information and information technologies in society.

The Ubiquitin-Proteasome System (UPS) and Viral Infection in Plants.

The ubiquitin–proteasome system (UPS) is crucial in maintaining cellular physiological balance. The UPS performs quality control and degrades proteins that have already fulfilled their regulatory purpose. The UPS is essential for cellular and organic homeostasis, and its functions regulate DNA repair, gene transcription, protein activation, and receptor trafficking. Besides that, the UPS protects cellular immunity and acts on the host’s defense system. In order to produce successful infections, viruses frequently need to manipulate the UPS to maintain the proper level of viral proteins and hijack defense mechanisms. This review highlights and updates the mechanisms and strategies used by plant viruses to subvert the defenses of their hosts. Proteins involved in these mechanisms are important clues for biotechnological approaches in viral resistance.

Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop

New Approach Methodologies (NAMs) are considered to include any in vitro, in silico or chemistry-based method, as well as the strategies to implement them, that may provide information that could inform chemical safety assessment. Current chemical legislation in the European Union is limited in its acceptance of the widespread use of NAMs. The European Partnership for Alternative Approaches to Animal Testing (EPAA) therefore convened a ‘Deep Dive Workshop’ to explore the use of NAMs in chemical safety assessment, the aim of which was to support regulatory decisions, whilst intending to protect human health. The workshop recognised that NAMs are currently used in many industrial sectors, with some considered as fit for regulatory purpose. Moreover, the workshop identified key discussion points that can be addressed to increase the use and regulatory acceptance of NAMs. These are based on the changes needed in frameworks for regulatory requirements and the essential needs in education, training and greater stakeholder engagement as well the gaps in the scientific basis of NAMs.

Politics and law as regulatory correlates of power

The current article attempts to denote the relationship between the regulatory purpose of politics and law, which form coherent power as a dialectical unity of political power interested in the legal legitimation of its status and legal power, appealing to the power represented by the state, on the one hand, and their denial of each other as the embodiment of the paradigms of efficiency (politics) and legitimation (law), on the other hand. To meet that aim, general scientific (dialectical, comparative, historical-genetic, structural-functional), and also specific scientific (specific-sociological, formal-logical, historical-legal, comparative jurisprudence) methods are taken into consideration. Given the results of the study, the efficiency paradigm is determined by the factor of result, and the legitimation paradigm is determined by the factor of process. The interaction of these paradigms gives rise to an antinomic contradiction, which is an attributive characteristic of the political and legal regulation of social processes.

Pilot study to evaluate tools to collect pathologist annotations for validating machine learning algorithms.

Purpose: Validation of artificial intelligence (AI) algorithms in digital pathology with a reference standard is necessary before widespread clinical use, but few examples focus on creating a reference standard based on pathologist annotations. This work assesses the results of a pilot study that collects density estimates of stromal tumor-infiltrating lymphocytes (sTILs) in breast cancer biopsy specimens. This work will inform the creation of a validation dataset for the evaluation of AI algorithms fit for a regulatory purpose. Approach: Collaborators and crowdsourced pathologists contributed glass slides, digital images, and annotations. Here, "annotations" refer to any marks, segmentations, measurements, or labels a pathologist adds to a report, image, region of interest (ROI), or biological feature. Pathologists estimated sTILs density in 640 ROIs from hematoxylin and eosin stained slides of 64 patients via two modalities: an optical light microscope and two digital image viewing platforms. Results: The pilot study generated 7373 sTILs density estimates from 29 pathologists. Analysis of annotations found the variability of density estimates per ROI increases with the mean; the root mean square differences were 4.46, 14.25, and 26.25 as the mean density ranged from 0% to 10%, 11% to 40%, and 41% to 100%, respectively. The pilot study informs three areas of improvement for future work: technical workflows, annotation platforms, and agreement analysis methods. Upgrades to the workflows and platforms will improve operability and increase annotation speed and consistency. Conclusions: Exploratory data analysis demonstrates the need to develop new statistical approaches for agreement. The pilot study dataset and analysis methods are publicly available to allow community feedback. The development and results of the validation dataset will be publicly available to serve as an instructive tool that can be replicated by developers and researchers.

Abstract 460: Tools for collecting pathologist annotations and understanding interobserver variability

Abstract Background: The High Throughput Truthing (HTT) project is assessing pathologist agreement estimates of stromal tumor-infiltrating lymphocytes (sTILs) density in hematoxylin and eosin (H&E) stained breast cancer biopsy slides. The HTT project will create a validation dataset for artificial intelligence and machine learning (AI/ML) algorithms in digital pathology fit for a training, proficiency testing, and regulatory purpose. Methods: The pilot study crowdsourced pathologists to estimate sTIL density in 640 regions of interest (ROIs) across 64 slides via two modalities: an optical microscope (eeDAP) and two digital platforms (caMicroscope and PathPresenter). eeDAP is a hardware-software interface that presents the observer with pre-defined fields of view on H&E slides that corresponds to the ROI on a whole slide image. The PathPresenter and caMicroscope web-applications replicate the eeDAP workflow on the whole slide image without microscope hardware. In the workflow, pathologists evaluated the eligibility of an ROI for sTILs content then estimated the densities of tumor-associated stroma and sTILs in the ROI. Inter-pathologist agreement within ROIs was characterized with the root mean-squared difference. Using 72 of the highest variability ROIs selected from the pilot study, seven practicing pathologists participated in a subsequent focus group to improve the clinical training and data-collection workflows. Results: The pilot study collected 7,373 sTIL density estimates from 35 pathologists between February 2020 and May 2021. The focus group provided an additional 411 evaluations on 72 ROIs and in-depth discussions to identify pitfalls, gaps in training, and workflow improvements. Installation of eeDAP for physical data collection guided improvements in documentation and operation capabilities. Updated training materials refine the definition of tumor-associated stroma, provide reference images to differentiate sTILs from other cell types, and provide feedback during training. Digital and microscope platforms benefitted from enforcing registration and training, standardizing workflows, and accelerating eeDAP slide-image registration. Conclusions: The slides, images, and annotations provided by volunteer collaborators and participants for our pilot study led to improvements in data collection tools and crowdsourcing workflows to ensure consistency and minimize annotation variability. Our pilot dataset and analysis methods are available on a public HTT Github repository to allow open access to our methodology and feedback from the digital pathology and statistics communities. These data-collection and analysis methods are applicable to other quantitative biomarkers for validation of AI/ML algorithms. The lessons learned from this work will be applied to the HTT pivotal study and inform future quality data-collection methods of pathologist annotations. Citation Format: Katherine N. Elfer, Kim Blenman, Sarah N. Dudgeon, Victor Garcia, Anna Ehinger, Xiaoxian Li, Amy Ly, Dieter Peeters, Bruce Werness, Matthew Hanna, Roberto Salgado. Tools for collecting pathologist annotations and understanding interobserver variability [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 460.

Determination of the stability of a potable water production line using lean six sigma method: A case study of XYZ water factory

The research, being a case study, aims to determine the stability of the potable water production line of XYZ water factory, for possible improvement, using tools from the lean six sigma (LSS) methodology. This research was carried out on the mean weekly laboratory results of physicochemical water parameters (pH, conductivity, turbidity, alkalinity, chloride, total dissolved solids (TDS), magnesium, nitrates, sulphate, hardness, calcium, lead, copper, iron, and zinc) for regulatory purpose. The data obtained were analysed using control charts from the minitab 2021 ® statistical software package. The values of the parameters (except iron) in the control charts were beyond the conventional limits at various points in time throughout the period. The research results showed that the water production process is not stable, indicative of assignable causes of variability in the production line for all the parameters. Therefore, there is need to carry out investigations to know the causes and take action to correct them. This could be achieved by deploying the appropriate tools in the lean six sigma (DMAIC) methodology.

Real world data and data science in medical research: present and future

Real world data (RWD) are generating greater interest in recent times despite being not new. There are various purposes of the RWD analytics in medical research as follows: effectiveness and safety of medical treatment, epidemiology such as incidence and prevalence of disease, burden of disease, quality of life and activity of daily living, medical costs, etc. The RWD research in medicine is a mixture of digital transformation, statistics or data science, public health, and regulatory science. Most of the articles describing the RWD or real-world evidence (RWE) in medical research cover only a portion of these specializations, which might lead to an incomplete understanding of the RWD. This article summarizes the overview and challenges of the RWD analysis in medical fields from methodological perspectives. As the first step for the RWD analysis, data source of the RWD should be comprehended. The progress of the RWD is closely related to the digitization, especially of medical administrative data and medical records. Second, the selection of appropriate statistical and epidemiological methods is highly critical for an RWD analysis than those for randomized clinical trials. This is because it contains greater varieties of bias, which should be controlled by balancing the underlying risk between treatment groups. Last, the future of the RWD is discussed in terms of overcoming limited data by proxy confounders, using unstructured text data, linking of multiple databases, using the RWD or RWE for a regulatory purpose, and evaluating values and new aspects in medical research brought by the RWD.