Risk assessment for human health effects often depends on evaluation of toxicological literature from a variety of sources. Risk assessors have limited resources for obtaining raw data, performing follow-on analyses or initiating new studies. These constraints must be balanced against a need to improve scientific credibility through improved statistical and analytical methods that optimize the use of available information. Computerized databases are used in toxicological risk assessment both for storing data and performing predictive analyses. Many systems provide primarily either bibliographic information or summary factual data from toxicological studies; few provide adequate information to allow application of dose-response models. The Exposure-Response database (ERDB) described here fills this gap by allowing entry of sufficiently detailed information on experimental design and results for each study, while limiting data entry to the most relevant. ERDB was designed to contain information from the open literature to support dose-response assessment and allow a high level of automation in performance of various types of dose-response analyses. Specifically, ERDB supports emerging analytical approaches for dose-response assessment, while accommodating the diverse nature of published literature. Exposure and response data are accessible in a relational multi-table design, with closely controlled standard fields for recording values and free-text fields to describe unique aspects of the study. Additional comparative analyses are made possible through summary tables and graphic representations of the data contained within ERDB.
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http://dx.doi.org/10.1016/j.taap.2007.12.039 | DOI Listing |
Pharmaceuticals (Basel)
December 2024
Centre of Excellence for Long-Acting Therapeutics University of Liverpool, Liverpool L69 3BX, UK.
Background: The development of long-acting products of a characterized drug substance is of great interest. It is possible to support the development of these products with available clinical data by matching the exposure to a predefined bracket of a minimal concentration for efficacy and a maximal concentration for safety. This bracketing approach would cut down on the time and cost of new long-acting contraceptive products progressing to market.
View Article and Find Full Text PDFInt J Hyg Environ Health
December 2024
Centre for Occupational and Environmental Health, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
Background: We aimed to develop a method for assessing occupational styrene exposures for application in epidemiological studies on risks of lymphohematopoietic neoplasms and other malignant and non-malignant diseases in the European and the US glass reinforced plastics industries.
Method: We estimated a linear mixed effects model based on individual airborne personal measurements of styrene from the glass reinforced plastics industry in Denmark, Norway, Sweden, UK, and the US. The most suitable model was chosen based on its predictive power as assessed using cross validation with different combinations of predictors; and by comparing their prediction errors.
Environ Health Perspect
December 2024
Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.
Eur Heart J
October 2024
Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, 180 Fenglin Road, Shanghai 200032, China.
Clin Pharmacol Ther
December 2024
Clinical Pharmacology, AbbVie Inc., North Chicago, Illinois, USA.
Juvenile idiopathic arthritis (JIA) is the most prevalent pediatric rheumatic disease. While disease-modifying antirheumatic drugs (DMARDs), especially biologics, have greatly transformed the management of JIA, there remain some unmet medical needs that require new treatment options. The objective of this work was to describe and apply a modeling and simulation approach to extrapolate upadacitinib efficacy from the adult diseases, rheumatoid arthritis (RA) and psoriatic arthritis (PsA), to their respective pediatric diseases, polyarticular course JIA (pcJIA), and juvenile PsA (JPsA).
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