scholarly journals The Babel of Drugs: On the Consequences of Evidential Pluralism in Pharmaceutical Regulation and Regulatory Data Journeys

2020 ◽  
pp. 207-225
Author(s):  
Niccolò Tempini ◽  
David Teira
2015 ◽  
Author(s):  
Vishal Ahuja ◽  
John R. Birge ◽  
Chad Syverson ◽  
Elbert S. Huang ◽  
Min-Woong Sohn

2021 ◽  
pp. 002203452110202
Author(s):  
F. Schwendicke ◽  
J. Krois

Data are a key resource for modern societies and expected to improve quality, accessibility, affordability, safety, and equity of health care. Dental care and research are currently transforming into what we term data dentistry, with 3 main applications: 1) medical data analysis uses deep learning, allowing one to master unprecedented amounts of data (language, speech, imagery) and put them to productive use. 2) Data-enriched clinical care integrates data from individual (e.g., demographic, social, clinical and omics data, consumer data), setting (e.g., geospatial, environmental, provider-related data), and systems level (payer or regulatory data to characterize input, throughput, output, and outcomes of health care) to provide a comprehensive and continuous real-time assessment of biologic perturbations, individual behaviors, and context. Such care may contribute to a deeper understanding of health and disease and a more precise, personalized, predictive, and preventive care. 3) Data for research include open research data and data sharing, allowing one to appraise, benchmark, pool, replicate, and reuse data. Concerns and confidence into data-driven applications, stakeholders’ and system’s capabilities, and lack of data standardization and harmonization currently limit the development and implementation of data dentistry. Aspects of bias and data-user interaction require attention. Action items for the dental community circle around increasing data availability, refinement, and usage; demonstrating safety, value, and usefulness of applications; educating the dental workforce and consumers; providing performant and standardized infrastructure and processes; and incentivizing and adopting open data and data sharing.


2018 ◽  
Vol 44 (4) ◽  
pp. 253-262 ◽  
Author(s):  
Julie Parle ◽  
Rebecca Hodes ◽  
Thembisa Waetjen

This article provides a history of three pharmaceuticals in the making of modern South Africa. Borrowing and adapting Arthur Daemmrich’s term ‘pharmacopolitics’, we examine how forms of pharmaceutical governance became integral to the creation and institutional practices of this state. Through case studies of three medicaments: opium (late 19th to early 20th century), thalidomide (late 1950s to early 1960s) and contraception (1970s to 2010s), we explore the intertwining of pharmaceutical regulation, provision and consumption. Our focus is on the modernist imperative towards the rationalisation of pharmaceutical oversight, as an extension of the state’s bureaucratic and ideological objectives, and, importantly, as its obligation. We also explore adaptive and illicit uses of medicines, both by purveyors of pharmaceuticals, and among consumers. The historical sweep of our study allows for an analysis of continuities and changes in pharmaceutical governance. The focus on South Africa highlights how the concept of pharmacopolitics can usefully be extended to transnational—as well as local—medical histories. Through the diversity of our sources, and the breadth of their chronology, we aim to historicise modern pharmaceutical practices in South Africa, from the late colonial era to the Post-Apartheid present.


2018 ◽  
Author(s):  
Nicholas L Panchy ◽  
John P. Lloyd ◽  
Shin-Han Shiu

AbstractThe collection all TFs, target genes and their interactions in an organism form a gene regulatory network (GRN), which underly complex patterns of transcription even in unicellular species. However, identifying which interactions regulate expression in a specific temporal context remains a challenging task. With multiple experimental and computational approaches to characterize GRNs, we predicted general and phase-specific cell-cycle expression in Saccharomyces cerevisiae using four regulatory data sets: chromatin immunoprecipitation (ChIP), TF deletion data (Deletion), protein binding microarrays (PBMs), and position weight matrices (PWMs). Our results indicate that the source of regulatory interaction information significantly impacts our ability to predict cell-cycle expression where the best model was constructed by combining selected TF features from ChIP and Deletion data as well as TF-TF interaction features in the form of feed-forward loops. The TFs that were the best predictors of cell-cycle expression were enriched for known cell-cycle regulators but also include regulators not implicated in cell-cycle regulation previously. In addition, ChIP and Deletion datasets led to the identification different subsets of TFs important for predicting cell-cycle expression. Finally, analysis of important TF-TF interaction features suggests that the GRN regulating cell cycle expression is highly interconnected and clustered around four groups of genes, two of which represent known cell-cycle regulatory complexes, while the other two contain TFs that are not known cell-cycle regulators (Ste12-Tex1 and Rap1-Hap1-Msn4), but are nonetheless important to regulating the timing of expression. Thus, not only do our models accurately reflect what is known about the regulation of the S. cerevisiae cell cycle, they can be used to discover regulatory factors which play a role in controlling expression during the cell cycle as well as other contexts with discrete temporal patterns of expression.


2021 ◽  
Vol 2019 (005r1) ◽  
pp. 1-85
Author(s):  
Antonio Falato ◽  
◽  
Diana Iercosan ◽  
Filip Zikes ◽  
◽  
...  

Banks use trading as a vehicle to take risk. Using unique high-frequency regulatory data, we estimate the sensitivity of weekly bank trading profits to aggregate equity, fixed-income, credit, currency and commodity risk factors. Our estimates imply that U.S. banks had large trading exposures to equity market risk before the Volcker Rule, which they curtailed afterwards. They also have exposures to credit and currency risk. The results hold up in a quasi-natural experimental design that exploits the phased-in introduction of reporting requirements to address identification. Heterogeneity and placebo tests further corroborate the results. Counterfactual stress-test analyses quantify the financial stability implications.


2020 ◽  
Vol 11 (2) ◽  
pp. 141-148
Author(s):  
Dewi Fitriasari ◽  
Naoko Kawahara

The research proposed a Time-Driven Activity-Based Costing (TDABC) model for cost and human capital analysis in a small startup in Indonesia. TDABC discussed and illustrated the integration of capabilities into cost and performance in startups. The researchers applied a qualitative simulation method. The data were taken from actual regulatory data of wage and salary from the local government of Jakarta. The other data were simulated data based on a software development process for a small startup. The result indicates that the TDABC can assist the company to trace its performance and costs. Additional factors in implementing the costing system are provided for further research and practical considerations in adopting the costing system.


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