Challenges in setting Permitted Daily Exposure (PDE) Limits for pharmaceuticals: A review

2021 ◽  
pp. 1-16
Author(s):  
Varun Ahuja ◽  
Mohan Krishnappa
Keyword(s):  
Drug Product ◽  
Relevant Literature ◽  
Pharmaceutical Manufacturing ◽  
Data Driven ◽  
Cross Contamination ◽  
Daily Exposure ◽  
Risk Assessor ◽  
Carry Over ◽  
Pde Methods ◽  
The Given

BACKGROUND: When more than one drug is manufactured at a shared facility or equipment in pharmaceutical manufacturing, the potential carry-over of the retained residue of existing drug product on product contact parts of the equipment to the next product can be a source of cross contamination. Permitted daily exposure (PDE) is derived based on the complete nonclinical and clinical data available and is a dose that is unlikely to cause adverse effects if an individual is exposed, by any route, at or below this dose every day over a lifetime. OBJECTIVE: The objective was to present a comprehensive review of available scientific knowledge for derivation of PDE. METHODS: PubMed and ScienceDirect databases were searched using keywords “PDE” and “pharmaceuticals” and all the relevant literature up to March 2021 was reviewed. We have also calculated PDEs for Tobramycin (CAS No. 32986-56-4) and Acetyl Salicylic Acid (ASA, CAS No. 50-78-2). RESULTS: This research will be useful for scientists working in the PDE domain. The given examples emphasize the importance of use of human data in calculating PDE. CONCLUSION: The duty of the risk assessor entrusted with setting PDEs is to derive a data driven, scientifically justified value that is safe for patients, while avoiding unjustified conservativeness that puts unnecessary burden on manufacturing.

scholarly journals Data-Driven Modeling of Mechanical Properties of Cast Iron Using Fuzzy Logic

2020 ◽  
Author(s):  
He Tan ◽  
Vladimir Tarasov ◽  
Vasileios Fourlakidis ◽  
Attila Dioszegi
Keyword(s):  
Experimental Data ◽  
Fuzzy Logic ◽  
Cast Iron ◽  
Materials Science ◽  
Fatigue Behavior ◽  
Relevant Literature ◽  
Data Driven ◽  
Fuzzy Logic Systems ◽  
Data Driven Approach ◽  
Data Driven Modeling

For many industries, an understanding of the fatigue behavior of cast iron is important but this topic is still under extensive research in materials science. This paper offers fuzzy logic as a data-driven approach to address the challenge of predicting casting performance. However, data scarcity is an issue when applying a data-driven approach in this field; the presented study tackled this problem. Four fuzzy logic systems were constructed and compared in the study, two based solely upon experimental data and the others combining the same experimental data with data drawn from relevant literature. The study showed that the latter demonstrated a higher accuracy for the prediction of the ultimate tensile strength for cast iron.

scholarly journals A Review of Charge Pump Topologies for the Power Management of IoT Nodes

Electronics ◽  
2019 ◽  
Vol 8 (5) ◽  
pp. 480 ◽  
Author(s):  
Andrea Ballo ◽  
Alfio Dario Grasso ◽  
Gaetano Palumbo
Keyword(s):  
Internet Of Things ◽  
Power Management ◽  
Energy Harvester ◽  
State Of The Art ◽  
Charge Pump ◽  
The State ◽  
Data Driven ◽  
Design Specifications ◽  
The Given ◽  
Insight Into

With the aim of providing designer guidelines for choosing the most suitable solution, according to the given design specifications, in this paper a review of charge pump (CP) topologies for the power management of Internet of Things (IoT) nodes is presented. Power management of IoT nodes represents a challenging task, especially when the output of the energy harvester is in the order of few hundreds of millivolts. In these applications, the power management section can be profitably implemented, exploiting CPs. Indeed, presently, many different CP topologies have been presented in literature. Finally, a data-driven comparison is also provided, allowing for quantitative insight into the state-of-the-art of integrated CPs.

scholarly journals Stability, Homogeneity and Carry-Over of Amoxicillin, Doxycycline, Florfenicol and Flubendazole in Medicated Feed and Drinking Water on 24 Pig Farms

Antibiotics ◽  
2020 ◽  
Vol 9 (9) ◽  
pp. 563
Author(s):  
Femke Vandael ◽  
Helena Cardoso de Carvalho Ferreira ◽  
Mathias Devreese ◽  
Jeroen Dewulf ◽  
Els Daeseleire ◽  
...  
Keyword(s):  
Drinking Water ◽  
Cross Contamination ◽  
Clinical Practices ◽  
Therapeutic Concentration ◽  
Target Concentration ◽  
Factors Affecting ◽  
Pig Farms ◽  
Oral Group ◽  
Carry Over ◽  
On Farm

The vast majority of medicines in pig rearing are administered via oral group medication through medicated feed and drinking water. However, relevant on-farm factors affecting the concentration of these drugs in feed and drinking water, such as the homogeneity, stability, and cross-contamination, are largely unknown. To characterize these factors, samples of medicated feed and drinking water were taken on 24 Belgian pig farms during treatment and 2 days thereafter, as well as at different on-farm sampling sites from production to feeding troughs or drinking nipples. The samples contained amoxicillin, doxycycline, florfenicol, or flubendazole. Additionally, a questionnaire was completed. In contrast to the results of medicated feed, results of medicated water showed a large between-farm variation in antimicrobial drug concentration. The therapeutic concentration range was only met in 2 out of 11 farms using medicated feed, and in 3 out of 13 farms using medicated water. Medicated feed concentrations were often below the therapeutic concentration range mentioned in the Summary of Product Characteristics, while drinking water concentrations were just as often above as they were below the advised target concentration range. Drug residues measured 2 days after the end of therapy with both feed and water medication rarely exceeded 1% of the lowest therapeutic concentration. This study demonstrates that recommendations on good clinical practices for oral group medication in the pig industry are highly needed.

scholarly journals Competence-Oriented, Data-Driven Approach for Sustainable Development in University-Level Education

2021 ◽  
Vol 13 (17) ◽  
pp. 9977
Author(s):  
Szabina Fodor ◽  
Ildikó Szabó ◽  
Katalin Ternai
Keyword(s):  
Supply Chain ◽  
Labor Market ◽  
Supply Chain Management ◽  
Data Driven ◽  
Green Supply Chain ◽  
Chain Management ◽  
Job Advertisements ◽  
Data Driven Approach ◽  
Market Needs ◽  
The Given

Higher education has a number of key roles to play in accelerating progress toward sustainability goals. It has a responsibility to provide and teach curricula that are tailored to labor market needs, to help change people’s attitudes and motivation toward sustainability, and to reduce inequalities between different students. Course leaders and developers of curricula should monitor and assess these needs in order to improve their curricula from time to time. In the present work, we describe a data-driven approach based on text-mining techniques to identify the competences required for a given position based on job advertisements. To demonstrate the usefulness of our suggested method, the supply chain management occupation was selected as the supply chain is a constantly changing domain that is highly affected by green activities and initiatives, and the COVID-19 pandemic strongly influenced this sector, as well. This data-driven process allowed the identification of required soft and hard skills contained in job descriptions. However, it was found that some important concepts of green supply chain management, such as repair and refurbishment, were only marginally mentioned in the job advertisements. Therefore, in addition to labor market expectations, a business process model from relevant green supply chain management literature was developed to complement the required competences. The given new techniques can support the paradigm shift toward sustainable development and help curriculum developers and decision makers assess labor market needs in the area of sustainability skills and competences. The given result can serve as an input of outcome-based training development to design learning objective-based teaching materials.

scholarly journals EHreact: Extended Hasse Diagrams for the Extraction and Scoring of Enzymatic Reaction Templates

2021 ◽  
Author(s):  
Esther Heid ◽  
Samuel Goldman ◽  
Karthik Sankaranarayanan ◽  
Connor W. Coley ◽  
Christoph Flamm ◽  
...  
Keyword(s):  
Expert Knowledge ◽  
Enzymatic Reaction ◽  
Software Tool ◽  
Optimal Number ◽  
Data Driven ◽  
Enzymatic Reactions ◽  
Hasse Diagrams ◽  
Large Databases ◽  
Rule Sets ◽  
The Given

Data-driven computer-aided synthesis planning utilizing organic or biocatalyzed reactions from large databases has gained increasing interest in the last decade, sparking the development of numerous tools to extract, apply and score general reaction templates. The generation of reaction rules for enzymatic reactions is especially challenging, since substrate promiscuity varies between enzymes, causing the optimal levels of rule specificity and optimal number of included atoms to differ between enzymes. This complicates an automated extraction from databases and has promoted the creation of manually curated reaction rule sets. Here we present EHreact, a purely data-driven open-source software tool to extract and score reaction rules from sets of reactions known to be catalyzed by an enzyme at appropriate levels of specificity without expert knowledge. EHreact extracts and groups reaction rules into tree-like structures, Hasse diagrams, based on common substructures in the imaginary transition structures. Each diagram can be utilized to output a single or a set of reaction rules, as well as calculate the probability of a new substrate to be processed by the given enzyme by inferring information about the reactive site of the enzyme from the known reactions and their grouping in the template tree. EHreact heuristically predicts the activity of a given enzyme on a new substrate, outperforming current approaches in accuracy and functionality.

scholarly journals Workshop on Writing a Review of Relevant Literature in a Research Report for English Teachers in Bogor

2019 ◽  
Vol 3 (2) ◽  
pp. 97-107
Author(s):  
Anna Marietta Da Silva
Keyword(s):  
Professional Development ◽  
Literature Review ◽  
Community Service ◽  
Relevant Literature ◽  
English Teachers ◽  
Research Report ◽  
Report Writing ◽  
Catholic University ◽  
Research Article ◽  
The Given

The workshop on writing a review of relevant literature in a research paper is part of a series of workshop given to English teachers of Bogor Regency. The workshop series is part of the cooperation between Atma Jaya Catholic University of Indonesia and Pakuan University in terms of research and community service. The theme was chosen because of the needs of the teachers to write and publish their classroom action research report for their professional development. Therefore the goal of the workshop is to assist and guide the teachers in their report writing, particularly the literature review. The workshop consisted of explanation about a literature review of a research article, steps to write a review and analysis of samples of reviews. The participants mostly appreciated the content of the workshop and hoped that the following workshop theme will either extend the given materials or cover skills of writing other sections of a research article. They also gave some suggestions related to the technique of delivery and duration of the workshop.  

scholarly journals Real Estate as a Subject of Spatial Conflict Among Central and Local Authorities

2015 ◽  
Vol 23 (2) ◽  
pp. 91-101
Author(s):  
Alina Źróbek-Różańska ◽  
Elżbieta Zysk
Keyword(s):  
Data Analysis ◽  
Real Estate ◽  
Rural Areas ◽  
Relevant Literature ◽  
Interesting Case ◽  
Local Administration ◽  
Central Authority ◽  
Local Authorities ◽  
Potential Conflict ◽  
The Given

Abstract Currently, real estate located in rural areas neighboring cities are under pressure to become a location for the realization of urban and metropolitan projects. Thus, spatial conflicts are an inherent characteristic of modern urban development. Such conflicts vary in terms of the scope, intensity and course they take. An interesting case illustrating the given issue can be the conflict over real estate owned by the State Treasury (central authority) and localized within the power of local authorities (gminas). Such a situation requires mediating and producing an outcome that satisfies the goals of both sides. The authors based the deliberations on the topic of spatial conflicts on the example of the relation between the Agricultural Property Agency division in Olsztyn (APA Olsztyn) and the smallest local administration units (gminas) located within the borders of the Warmia-Masuria (Województwo Warmińsko-Mazurskie) and Podlasie (Województwo Podlaskie) Provinces. The aim of the research was to describe the background for potential conflict and to study its proceedings. The aim was achieved through studies of relevant literature and data analysis.

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