Regulatory toxicology and pharmacology : RTP
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Regul. Toxicol. Pharmacol. · Aug 2006
Comparative StudyEvaluation of the toxic potentials of a new camptothecin anticancer agent CKD-602 on fertility and early embryonic development in rats.
This study examined the potential adverse effects of a new camptothecin anticancer agent, CKD-602, on the fertility and early embryonic development of Sprague-Dawley rats. Ninety-six rats of each gender were divided into four groups: three treatment groups and a control group. CKD-602 was administered intravenously to male rats at 0, 4.7, 14, and 42 microg/kg from 63 days prior to mating until the end of the mating period, and to female rats from 14 days before mating until day 6 of gestation. ⋯ No treatment-related effect on the histopathological findings, sexual cycle, pre-coital time, mating index, fertility index, pregnancy index, and sperm parameters was observed. There were no adverse effects on the general findings and reproductive performance of the parent animals and early embryonic development in the low and medium dose groups. Overall, the no-observed-adverse-effect levels (NOAELs) of CKD-602 are believed to be 14 microg/kg for both general toxicity and early embryonic development, and more than 42 microg/kg for the reproductive performance of the parent animals.
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Regul. Toxicol. Pharmacol. · Feb 2006
Modern regulatory impact analysis: the experience of the European Union.
This paper begins by explaining the importance of improving the quality of the regulatory process, particularly in the European Union (EU), using tools and techniques such as Regulatory Impact Assessment (RIA). It describes the principal features of the RIA process, including good practices and practical problems. ⋯ A further section describes recent work undertaken by Business Decisions Limited and THE WEINBERG GROUP on Impact Assessments for the Animal Health Industry, the Polycarbonates Industry and the Nickel Industry. The paper finally draws a number of conclusions and makes a number of recommendations for further improvements in the quality of the regulatory process in the European Union.
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Regul. Toxicol. Pharmacol. · Feb 2006
Enhancing the role of science in the decision-making of the European Union.
Used well, science provides effective ways of identifying potential risks, protecting citizens, and using resources wisely. It enables government decisions to be based on evidence and provides a foundation for a rule-based framework that supports global trade. To ensure that the best available science becomes a key input in the decisions made by EU institutions, this abridged version of a working paper produced for the European Policy Centre, a leading, independent think tank, considers how science is currently used in the policy and decision-making processes of the EU, what the limitations of scientific evidence are, and how a risk assessment process based on scientific 'good practices' can be advantageous. Finally, the paper makes recommendations on how to improve the use of science by EU institutions.
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Regul. Toxicol. Pharmacol. · Feb 2006
Science and norms in policies for sustainable development: assessing and managing risks of chemical substances and genetically modified organisms in the European Union.
Use of chemical substances and genetically modified organisms cause complex problems characterised by scientific uncertainty and controversies. Aiming at sustainable development, policies for assessment, and management of risks in the two areas are under development in the European Union. ⋯ It is shown, however, that a number of steps ought to be taken to better implement the principles through different policy measures. In doing so, and by recognising the role of both science and norms, the decision-making on risks related to the use of chemicals or genetically modified organisms can be improved to better promote sustainable development.
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Regul. Toxicol. Pharmacol. · Feb 2006
Principles and practices of health risk assessment under current EU regulations.
Risk assessments serve as the foundation of regulatory decision-making on whether to take actions to reduce (or otherwise manage) a toxicological or ecotoxicological risk or not. To understand the complex process that leads from the generation of scientific data, via risk assessment to risk management decision-making, close studies of the scientific basis and risk assessment methods must be undertaken. ⋯ In the second part the actual workings of this system are exemplified by the results from case studies of the risk assessment processes for trichloroethylene and for acrylamide. The analysis and comparison of these two cases illustrates: (1) that generation of a large amount of data does not ensure consensus among risk assessors, (2) that controversy can regard different levels of detail, (3) that controversy can arise at different organizational and theoretical levels, (4) that risk assessments may be subject to (public) criticism even if the experts agree, and (5) that "scientific" controversies have a significant policy component.