Exposure Information

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The Experts below are selected from a list of 318 Experts worldwide ranked by ideXlab platform

Halûk Özkaynak - One of the best experts on this subject based on the ideXlab platform.

Thomas E. Mckone - One of the best experts on this subject based on the ideXlab platform.

Marie L. De Bruin - One of the best experts on this subject based on the ideXlab platform.

  • Traceability of biologicals : present challenges in pharmacovigilance
    Expert opinion on drug safety, 2014
    Co-Authors: Niels S. Vermeer, Irina Spierings, Aukje K. Mantel-teeuwisse, Sabine M. J. M. Straus, Thijs J. Giezen, Hubert G. M. Leufkens, Toine C. G. Egberts, Marie L. De Bruin
    Abstract:

    Traceability is important in the postmarketing surveillance of biologicals, since changes in the manufacturing process may give rise to product- or batch-specific risks. With the expected expansion of the biosimilar market, there have been concerns about the ability to trace individual products within pharmacovigilance databases. The authors discuss the present challenges in the traceability of biologicals in relation to pharmacovigilance, by exploring the processes involved in ensuring traceability. They explore both the existing systems that are in place for the recording of Exposure Information in clinical practice, as well as the critical steps involved in the transfer of Exposure data to various pharmacovigilance databases. The existing systems ensure the traceability of biologicals down to the manufacturer within pharmacy records, but do not support the routine recording of batch Information. Expected changes in supply chain standards provide opportunities to systematically record detailed Exposure Information. Spontaneous reporting systems are the most vulnerable link in ensuring traceability, due to the manual nature of data transfer. Efforts to improve the traceability should, in the short term, be focused toward encouraging health professionals and patients to systematically record and report detailed Exposure Information. Long-term solutions lie in expanding the accessibility to, and increasing the electronic exchange of Exposure data.

  • Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases
    Drug safety, 2013
    Co-Authors: Niels S. Vermeer, Aukje K. Mantel-teeuwisse, Sabine M. J. M. Straus, Hubert G. M. Leufkens, Toine C. G. Egberts, Francois Domergue, Marie L. De Bruin
    Abstract:

    Background Adverse drug reactions (ADRs) of biopharmaceuticals can be batch or product specific, resulting from small differences in the manufacturing process. Detailed Exposure Information should be readily available in systems for postmarketing safety surveillance of biopharmaceuticals, including spontaneous reporting systems (SRSs), in which reports of ADRs are collected.

Ken Sexton - One of the best experts on this subject based on the ideXlab platform.

  • The Importance of Human Exposure Information: A Need for Exposure-Related Data Bases to Protect and Promote Public Health
    Annual review of public health, 1995
    Co-Authors: Diane K. Wagener, Sherry G. Selevan, Ken Sexton
    Abstract:

    As a subfield of public health, environmental health is concerned with evaluating and ameliorating the effects of people on the environment and the effects of the environment on people. Separating hazards from risks, and characterizing the magnitude, likelihood, and uncertainty of risks is at the heart of environmental health in the 1990s. To this end, a full range of data is needed, including data that characterize the distribution of hazards, the population potentially at risk, and the contact between people and pollution that creates the risk. Several government-sponsored data systems contain Information on a range of Exposure estimators. The challenge is to develop meaningful, properly validated models to identify public health needs and evaluate public health programs.

  • Improving Exposure assessment by monitoring human tissues for toxic chemicals.
    Journal of exposure analysis and environmental epidemiology, 1995
    Co-Authors: James L. Pirkle, Larry L. Needham, Ken Sexton
    Abstract:

    Typically, the availability of appropriate data to estimate human Exposures to toxic chemicals is scarce. Consequently, Exposure assessments are often based on indirect surrogates of Exposure, such as a combination of questionnaire data on time-activities and concentrations of toxic chemicals measured in environmental media (e.g., air, water, food, soil, dust). Recent advances, however, make it technically feasible and relatively affordable to measure low levels of multiple toxic chemicals in accessible human tissues (e.g., blood, urine). The increasing availability of biological markers for Exposure, along with improvements in pharmacokinetic understanding, present new opportunities to estimate Exposure from human tissue measurements and from knowledge of intake and uptake parameters. Biological monitoring provides Exposure Information that is usually complementary to the type of Exposure Information obtained from environmental monitoring. Biological and environmental monitoring can be used separately or together in order to meet desired objectives. We present here a discussion of the value of biological monitoring for improving Exposure assessment. We emphasize the role of biological monitoring in identifying high-priority Exposures, evaluating the effectiveness of intervention and prevention efforts, identifying at-risk subpopulations, recognizing time trends in population Exposures, establishing reference ranges of tissue concentrations, and providing integrated dose measurements.

Frederick P Rivara - One of the best experts on this subject based on the ideXlab platform.

  • making the most of injury surveillance data using narrative text to identify Exposure Information in case control studies
    Injury-international Journal of The Care of The Injured, 2015
    Co-Authors: Janessa M Graves, Jennifer M Whitehill, Brent Edward Hagel, Frederick P Rivara
    Abstract:

    Introduction Free-text fields in injury surveillance databases can provide detailed Information beyond routinely coded data. Additional data, such as Exposures and covariates can be identified from narrative text and used to conduct case-control studies.

  • Making the most of injury surveillance data: Using narrative text to identify Exposure Information in case-control studies
    Injury, 2014
    Co-Authors: Janessa M Graves, Jennifer M Whitehill, Brent Edward Hagel, Frederick P Rivara
    Abstract:

    Free-text fields in injury surveillance databases can provide detailed Information beyond routinely coded data. Additional data, such as Exposures and covariates can be identified from narrative text and used to conduct case-control studies. To illustrate this, we developed a text-search algorithm to identify helmet status (worn, not worn, use unknown) in the U.S. National Electronic Injury Surveillance System (NEISS) narratives for bicycling and other sports injuries from 2005 to 2011. We calculated adjusted odds ratios (ORs) for head injury associated with helmet use, with non-head injuries representing controls. For bicycling, we validated ORs against published estimates. ORs were calculated for other sports and we examined factors associated with helmet reporting. Of 105,614 bicycling injury narratives reviewed, 14.1% contained sufficient helmet Information for use in the case-control study. The adjusted ORs for head injuries associated with helmet-wearing were smaller than, but directionally consistent, with previously published estimates (e.g., 1999 Cochrane Review). ORs illustrated a protective effect of helmets for other sports as well (less than 1). This exploratory analysis illustrates the potential utility of relatively simple text-search algorithms to identify additional variables in surveillance data. Limitations of this study include possible selection bias and the inability to identify individuals with multiple injuries. A similar approach can be applied to study other injuries, conditions, risks, or protective factors. This approach may serve as an efficient method to extend the utility of injury surveillance data to conduct epidemiological research. Copyright © 2014 Elsevier Ltd. All rights reserved.