Pharmacology, Toxicology and Environmental Health Commons^™

Development Of A Novel Method For Deriving Thresholds Of Toxicological Concern (Ttcs) For Vaccine Constituents, Jennifer Jessica White

USF Tampa Graduate Theses and Dissertations

Abstract

Safety assessment relating to the presence of impurities, residual materials and contaminants in vaccines is a focus area of research at the United States Food and Drug Administration (FDA). Sponsors who submit Investigational New Drug (IND) applications for new vaccine products must report the results of safety assessments to the Division of Vaccines and Related Products Applications (DVRPA). Scientifically defining thresholds of toxicological concern (TTCs) as they apply to vaccine constituents will provide a useful aid to the sponsors and public regarding safety assessments of compounds for which there is little or no toxicity data. TTCs are mathematically modeled …

The Role Of Ecological Models In Linking Ecological Risk Assessment To Ecosystem Services In Agroecosystems, Nika Galic, Amelie Schmolke, Valery Forbes, Hans Baveco, Paul Van Den Brink

Valery E Forbes

Agricultural practices are essential for sustaining the human population, but at the same time they can directly disrupt ecosystem functioning. Ecological risk assessment (ERA) aims to estimate possible adverse effects of human activities on ecosystems and their parts. Current ERA practices, however, incorporate very little ecology and base the risk estimates on the results of standard tests with several standard species. The main obstacles for a more ecologically relevant ERA are the lack of clear protection goals and the inherent complexity of ecosystems that is hard to approach empirically. In this paper, we argue that the ecosystem services framework offers …

Adding Value To Ecological Risk Assessment With Population Modeling, Valery E. Forbes, Peter Calow, Volker Grimm, Takehiko I, Hayashi, Tjalling Jager, Agnete Katholm, Annemette Palmqvist, Rob Pastorok, Dan Salvito, Richard Sibly, Julann Spromberg, John Stark, Richard A. Stillman

Valery E Forbes

Current measures used to estimate the risks of toxic chemicals are not relevant to the goals of the environmental protection process, and thus ecological risk assessment (ERA) is not used as extensively as it should be as a basis for cost-effective management of environmental resources. Appropriate population models can provide a powerful basis for expressing ecological risks that better inform the environmental management process and thus that are more likely to be used by managers. Here we provide at least five reasons why population modeling should play an important role in bridging the gap between what we measure and what …

The Role Of Ecological Models In Linking Ecological Risk Assessment To Ecosystem Services In Agroecosystems, Nika Galic, Amelie Schmolke, Valery E. Forbes, Hans Baveco, Paul Van Den Brink

Valery Forbes Publications

Agricultural practices are essential for sustaining the human population, but at the same time they can directly disrupt ecosystem functioning. Ecological risk assessment (ERA) aims to estimate possible adverse effects of human activities on ecosystems and their parts. Current ERA practices, however, incorporate very little ecology and base the risk estimates on the results of standard tests with several standard species. The main obstacles for a more ecologically relevant ERA are the lack of clear protection goals and the inherent complexity of ecosystems that is hard to approach empirically. In this paper, we argue that the ecosystem services framework offers …

Adding Value To Ecological Risk Assessment With Population Modeling, Valery E. Forbes, Peter Calow, Volker Grimm, Takehiko I, Hayashi, Tjalling Jager, Agnete Katholm, Annemette Palmqvist, Rob Pastorok, Dan Salvito, Richard Sibly, Julann Spromberg, John Stark, Richard A. Stillman

Valery Forbes Publications

Current measures used to estimate the risks of toxic chemicals are not relevant to the goals of the environmental protection process, and thus ecological risk assessment (ERA) is not used as extensively as it should be as a basis for cost-effective management of environmental resources. Appropriate population models can provide a powerful basis for expressing ecological risks that better inform the environmental management process and thus that are more likely to be used by managers. Here we provide at least five reasons why population modeling should play an important role in bridging the gap between what we measure and what …

Ecological Models In Support Of Regulatory Risk Assessments Of Pesticides: Developing A Strategy For The Future [Short Communication], Valery E. Forbes, Udo Hommen, Pernille Thorbek, Fred Heimbach, Paul J. Van Den Brink, Jörn Wogram, Hans-Hermann Thulke, Volker Grimm

Valery Forbes Publications

This brief communication reports on the main findings of the LEMTOX workshop, held from September 9 to 12,2007, at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany. The workshop brought together a diverse group of stakeholders from academia, regulatory authorities, contract research organizations, and industry, representing Europe, the United States, and Asia, to discuss the role of ecological modeling in risk assessments of pesticides, particularly under the European regulatory framework. The following questions were addressed: What are the potential benefits of using ecological models in pesticide registration and risk assessment? What obstacles prevent ecological modeling from being used …