Use Of Exposure Data Research Articles

Use of Exposure Data to Establish Causality in Drug-Adverse Event Relationships: An Example with Desvenlafaxine.

Causality algorithms help establish relationships between drug use and adverse event (AE) occurrence. High drug exposure leads to a higher likelihood of an AE being classified as an adverse drug reaction (ADR). However, there is a knowledge gap regarding what concentrations are predictive of ADRs, as this has not been systematically studied. In this work, the Spanish Pharmacovigilance System (SEFV) algorithm was used to define the relationship between the AE occurrence and drug administration in 178 healthy volunteers participating in five desvenlafaxine single-dose clinical trials, a selective serotonin and norepinephrine reuptake inhibitor that may cause dizziness, headache, nausea, dry mouth, constipation and hyperhidrosis. Eighty-three subjects presented 172 AEs that were classified as possible (101), conditional (31), unrelated (24) and probable (16). AUC∞ and Cmax were significantly higher in volunteers with vs. without ADRs (5981.24 ng·h/mL and 239.06 ng/mL and 4770.84 ng·h/mL and 200.69 ng/mL, respectively). Six of 19 subjects with conditional AEs with an SEFV score of 3 points presented an AUC∞ ≥ 6500 ng·h/mL or a Cmax ≥ 300 ng/mL (i.e., above percentile 75) and were summed one point on their SEFV score and classified as "possible" (4 points), improving the capacity of ADR detection.

Exposure considerations in human safety assessment: Report from an EPAA Partners’ Forum

Understanding and estimating the exposure to a substance is one of the fundamental requirements for safe manufacture and use. Many approaches are taken to determine exposure to substances, mainly driven by potential use and regulatory need. There are many opportunities to improve and optimise the use of exposure information for chemical safety. The European Partnership for Alternative Approaches to Animal Testing (EPAA) therefore convened a Partners’ Forum (PF) to explore exposure considerations in human safety assessment of industrial products to agree key conclusions for the regulatory acceptance of exposure assessment approaches and priority areas for further research investment. The PF recognised the widescale use of exposure information across industrial sectors with the possibilities of creating synergies between different sectors. Further, the PF acknowledged that the EPAA could make a significant contribution to promote the use of exposure data in human safety assessment, with an aim to address specific regulatory needs. To achieve this, research needs, as well as synergies and areas for potential collaboration across sectors, were identified.

52 Use of Exposure Data to Evaluate the Impact of the Boelv on Industry Practices; case Study ASW/RCF.

Abstract This study assesses the impact of the 0.3f/ml BOELV for aluminosilicate wools/refractory ceramic fibres (ASW/RCF), as implemented in 2020, on exposure levels at industrial sites. Now in its 26th year, CARE/PSP is the European programme collecting representative data for occupational exposure to airborne fibrous dust. With the changing regulatory landscape, CARE participants conducted a review of the data, focusing on evidence of reduced exposure or changed industrial practices since 2017 when the BOELV was first introduced. The data was split pre- and post- 2017 and also compared to alkaline earth silicate wool (AES/LBP) which is not classified and thus not covered by the BOELV, to consider the impact on exposure. An independent third-party statistician extracted the relevant data for this study. There are significant differences in workplace exposure among functional job categories (FJCs), since the introduction of the BOELV there has been a reduction in exposure, greater use of alternative AES/LBP and move to increased use of respiratory protective equipment (RPE) across all FJCs where ASW/RCF is being used. The data review for the period 2017-2021 has demonstrated an overall reduction in fibre exposure at both manufacturers and users’ facilities. The introduction of the BOELV for ASW/RCF has led to a greater awareness of the need to control fibrous dust. An increased uptake in the use of RPE and the use of RPE with higher protection factor is observed. There also appeared to be a move to alternative non-classified HTIW where appropriate.

Centralizing environmental datasets to support (inter)national chronic disease research: Values, challenges, and recommendations.

Background:Whereas environmental data are increasingly available, it is often not clear how or if datasets are available for health research. Exposure metrics are typically developed for specific research initiatives using disparate exposure assessment methods and no mechanisms are put in place for centralizing, archiving, or distributing environmental datasets. In parallel, potentially vast amounts of environmental data are emerging due to new technologies such as high resolution imagery and machine learning.Objectives:The Canadian Urban Environmental Health Research Consortium (CANUE) and the Geoscience and Health Cohort Consortium (GECCO) provide a proof of concept that centralizing and disseminating environmental data for health research is valuable and can accelerate discovery. In this essay, we argue that more efficient use of exposure data for environmental epidemiological research over the next decade requires progress in four key areas: metadata and data access portals, linkage with health databases, harmonization of exposure measures and models over large areas, and leveraging “big data” streams for exposure characterization and evaluation of temporal changes.Discussion:Optimizing the use of existing environmental data and exploiting emerging data streams can provide unprecedented research opportunities in environmental epidemiology through a better characterization of individuals’ exposures and the ability to study the intersecting impacts of multiple environmental features or urban attributes across different populations around the world. Proper documentation, linkage, and dissemination of new and emerging exposure data leads to a better awareness of data availability, a reduction of duplication of effort and increases research output.

Chemical exposures and cancer incidence in the Cancer Registry of Norway offshore cohort: project plan and preliminary results

ObjectivesSeveral studies have found associations between chemical exposures in the oil industry and cancer incidence. However, few studies have looked at Norwegian offshore oil industry workers. Thus, the main objective...

Measuring Exposure to Health Messages in Community-Based Intervention Studies: A Systematic Review of Current Practices

Accurately measuring exposure is critical to all intervention studies. The present review examines the extent to which best practices in exposure assessment are adhered to in community-based prevention and education studies. A systematic literature review was conducted examining community-based studies testing communication interventions, published in 2003-2007. Of 663 studies identified, 54 met all inclusion criteria and were reviewed for type of exposure assessment conducted (if any), use of exposure data in study analyses, and discussion of biases related to exposure assessment. Although a majority of studies (n = 38; 70%) assessed exposure, most of these used only a simple dichotomous measure (n = 31; 82%), less than half used exposure data to adjust intervention effects (n = 16; 42%), and only six (16%) addressed selective exposure as a possible source of bias. There is substantial room for improvement in measurement and analysis of exposure to communication in community-based disease prevention studies.

Collection and Use of Exposure Data from Human Milk Biomonitoring in the United States

Human milk is a unique biological matrix that can be used to estimate exposures in both the mother and the breastfed infant. In addition, the presence of environmental chemicals in human milk may act as a sentinel for exposures to a broader population. Several factors play a role in determining the quantity of chemicals transferred to milk and, subsequently, to the breastfeeding infant, including maternal, infant, and chemical characteristics. Exposure to certain environmental chemicals during critical periods can disrupt normal infant development, yet few data exist to quantify the hazards posed by environmental chemicals in human milk. Chemicals measured in human milk may also provide insights to agents suspect in altering breast development and breast-related disease risk. Carefully designed exposure assessment and toxicokinetic studies are needed to elucidate mechanisms and establish relationships between human milk and other biologic matrices. Data from human milk biomonitoring studies can be used to inform and validate models that integrate information about chemical properties, human metabolism, and biomarker concentrations. Additional research is needed to determine the degree to which environmental chemicals enter, are present in, and are excreted from human milk, their impact on the host (mother), and the extent of their bioavailability to breastfeeding infants. This article describes how the collection and use of exposure data from human milk biomonitoring in the United States can be designed to inform future research and policy. We thank the following organizations for generously providing support for the Workshop: the American Chemistry Council; the Centers for Disease Control and Prevention (C13/CCU323635-01); the Department of Health and Human Services, Health Resources and Services Administration (HHSH240200415021P); Health Canada (H405-03-ExSD079/4500078209); 3M; Pennsylvania State University College of Medicine; the Research Foundation for Health and Environmental Effects; and the U.S. Environmental Protection Agency, Office of Children’s Health (CH-83213101-0). The views expressed in this report are those of the authors and do not necessarily reflect the opinions and/or policies of the U.S. Environmental Protection Agency.

Data solutions for the 21st century: CEFIC's vision and intentions. The European Chemical Industry Council.

Information on workplace exposures to chemicals has a role and importance that goes beyond compliance with occupational exposure limits (OELs). In particular, the increasing use of exposure data in regulatory risk assessment processes places added demands on the need to collect such information. Industry's challenge is to respond to these developments in a manner that ensures data are obtained, archived, and analyzed to standards consistent with evolving stakeholder expectations.

The use of exposure data in different stages of home and leisure injury prevention. Can exposure data add to consumer safety?

In the field of home and leisure safety, data on exposure are generally not measured, and only in a limited number of cases is exposure taken into account as a factor possibly influencing the conclusions. A study was set up to investigate the possibilities and advantages of measuring exposure in the field of home and leisure safety. The main question therefore was: How can exposure data best be measured and in what fields of consumer safety? The ultimate question is: Can exposure data increase home and leisure safety? The literature on exposure, risk assessment and priority setting was surveyed to gain insight in theoretical and methodological issues related to exposure measurement. A number of studies actually measuring exposure in relation to home and leisure accidents were analyzed Exposure measurement is rarely found in the field of consumer safety. There are several definitions of exposure, and numerous ways to measure it. In the field of home and leisure accidents exposure time is the most commonly used parameter. If exposure is measured in the field of home and leisure safety, the reasons for doing so are diverse, as are the methods for obtaining and interpreting the data. Many authors mention validity and reliability problems. A standardized and more scientific method for exposure measurement might be a solution, but from a practical point of view it must be acknowledged that it is probably impossible to develop one method that can serve all purposes. Especially in the field of priority setting and risk analysis, taking exposure into account does result in other priorities. It can give a new impact to home and leisure accident prevention. This can be especially meaningful when there is a need or a wish to target individual or group risks instead of collective or societal risks.

Role of exposure databases in risk assessment.

Risk assessments have assumed an increasingly important role in the management of risks in this country. The determination of which pollutants or public health issues are to be regulated, the degree and extent of regulation, and the priority assigned to particular problems are all areas of risk assessment that influence the country's $100 billion annual investment in environmental protection. Recent trends in public policy have brought the practice of risk assessment under greater scrutiny. As policy makers increasingly insist that specific numerical risk levels (so-called bright lines) be incorporated into regulatory decisions, the stakes for good risk assessment practice, already high, are raised even further. Enhancing the scientific basis of risk assessments was a major goal of the Workshop on Exposure Databases. In this article, we present the Risk Assessment Work Group's evaluation of the use of exposurerelated databases in risk assessment and the group's recommendations for improvement. The work group's discussion focused on the availability, suitability, and quality of data that underly exposure assessments, a critical component of risk assessment. The work group established a framework for evaluation, based on exposure scenarios typically used in regulatory decisions. The scenarios included examples from Superfund, the Clean Air Act, the Toxic Substances Control Act, and other regulatory programs. These scenarios were used to illustrate current use of exposure data, to highlight gaps in existing data sources, and to discuss how improved exposure information can improve risk assessments. The work group concluded that many of the databases available are designed for purposes that do not meet exposure and risk assessment needs. Substantial gaps exist in measurements of actual human exposure and in the data necessary to model exposures, to characterize distributions of exposure, to identify high-risk groups, and to identify possible environmental inequities in exposure. The work group, on the basis of its findings, made both short-term and longer-term recommendations for improving the collection of exposure data in the future.

Regulatory decision making and the need for and the use of exposure data on pesticides determined to be teratogenic in test animals.

Major efforts have been made in the development of a system that takes the reviewer step-by-step by the use of the developmental toxicity and exposure assessment data to a recommended risk assessment and risk management position. Thereupon a set of regulatory decisions can be arrived at that are backed up by sound scientific analysis. Examples of pesticides that have been found to be teratogenic in animal testing are provided to demonstrate the process of use of exposure data in making risk assessment and management decisions.

Use of exposure data in occupational reproductive studies.

Accurately characterizing worker exposure presents some unique problems in occupational reproductive studies. The latency period between exposure and the adverse event may be relatively brief - days, weeks, or months. Inaccurately identifying the specific exposure period which initiated the adverse event may then contribute to sizeable misclassification errors. This paper discusses different types of exposure models that can be used to help reduce misclassification and delineate the exposure-effect relationships more accurately. The advantages and disadvantages of exposure data sources are also discussed.