Showing papers in "Regulatory Toxicology and Pharmacology in 2009"

TL;DR: An overview of scientific issues that need to be addressed with priority in order to improve the risk assessment of nanotechnologies and nanoparticles in food products is given.

TL;DR: Assessments for potential impact to human health from environmental exposures were carried out for 44 active pharmaceutical ingredients (APIs) marketed by GlaxoSmithKline, representing approximately 22 general pharmacological classes exhibiting a broad spectrum of therapeutic activities.

TL;DR: The immunological basis of anti-drug antibody formation to biopharmaceuticals (immunogenicity) in laboratory animals, and approaches for generating and interpreting immunogenicity data from nonclinical safety studies of biotechnology-derived therapeutics to support their progression to clinical evaluation are described.

TL;DR: A broad overview of human safety exposure-based risk assessment used at Procter & Gamble for absorbent hygiene products is provided.

TL;DR: The overall results indicate that lead in lipsticks and eye shadows are below the FDA lead limit as impurities and, thus, probably have no significant toxicological effects.

TL;DR: It is unlikely that humans are suffering adverse developmental effects from current environmental exposure to these phthalate esters, and the results of the cumulative risk assessments for both a US and a German population show that the hazard index is below one.

TL;DR: In this paper, the authors compared the resistance to digestion of two cow's milk allergens, beta-casein, and beta-lactoglobulin (beta-Lg), in a single laboratory.

TL;DR: The collective evidence supports the conclusion that the ingredient, Sucralose, is safe for use in food and that the sucralose-mixture product, Granulated SPLENDA No Calorie Sweetener, is also safe for its intended use.

TL;DR: Results indicate that p-nitrophenol should be considered a non-genotoxic impurity and, as a drug impurity, a threshold limit of 4 mg/day would be set (per ICH Q3C).

TL;DR: The utility of HTS assays to identify potential genotoxicity hazard in the larger context of the ToxCast project was evaluated, to aid prioritization of environmentally relevant chemicals for further testing and assessment of carcinogenicity risk to humans.

TL;DR: A 35-day toxicity study on ginger in rats provides a new understanding of the toxicological properties of ginger and shows that chronic administration of ginger was not associated with any mortalities and abnormalities in general conditions, behavior, growth, and food and water consumption.

TL;DR: In a single dose-toxicity study, two adult Cape Griffon Vultures with severe injuries, that were considered to have a very poor prognostic outcome, were dosed intravenously with diclofenac at 0.8 mg/kg.

TL;DR: Investigation of the origin of active pharmaceutical ingredients in 242 selected products on the Swedish market found that the APIs in 71 products originated from Indian manufacturers sending their waste to a treatment plant where unprecedented amount of environmental pollution with broad-spectrum antibiotics and other drugs recently has been documented.

TL;DR: An approach is described for refining this aggregate exposure using data on co-use and non-use patterns of product use, extent of products in which the ingredient is used and dermal penetration and metabolism, and the relative refinement in the aggregate exposure from incorporating these data is illustrated.

TL;DR: The objectives of REACH cannot be achieved under the current risk assessment approach and a mind set change is urgently needed: risk assessment should move away from a labor-intensive and animal-consuming approach to intelligent and pragmatic testing, by combining exposure and hazard data effectively and trying to group chemicals ( category approaches.

TL;DR: The safety assessments for skin irritation/corrosion of new chemicals for use in cosmetics can be confidently accomplished using exclusively alternative methods.

TL;DR: Estimates of exposure obtained by filter analysis and biomarkers of exposure correlate significantly over a wide range of smoke exposures and that filter analysis may provide a simple and effective alternative to biomarkers for estimating smokers' exposure are shown.

TL;DR: Impact of draft maximal levels for NDL-PCBs in some foodstuffs was evaluated and exposure scenario indicates that use of European draft MLs would have a very limited impact on the French population dietary exposure compared with the existing situation (no MLs).

TL;DR: Improved identification and communication of possible drug-induced liver injury is needed to avoid potentially serious and/or fatal drug rechallenge and Clinicians should generally avoid such rechallenges.

TL;DR: In this framework, the cumulative exposure to common mechanism chemicals is addressed by incorporation of the relative potency factor (RPF) approach and the framework is demonstrated by the cumulative risk assessment of organophosphorus pesticides (OPs).

TL;DR: Results indicate a low subchronic toxicity of the tested materials in mice and a possible alteration in the oxidative metabolism, however, further tests are required to better elucidate the effects of these compounds in the antioxidant system.

TL;DR: This report describes the development of quantitative structure-activity relationship (QSAR) models for predicting rare drug-induced liver and urinary tract injury in humans based upon a database of post-marketing adverse effects (AEs) linked to approximately 1600 chemical structures.

TL;DR: The data indicated that the region of Japan, Korea, Madagascar and Philippines have the highest seafood consumption, followed by the Nordic-Baltic countries and South-East Asia, and none of the seafood groups had a median contaminant concentration above the EU maximum limits.

TL;DR: It is unlikely several chemicals that cause mouse lung tumors via CYP2F2 metabolism will cause lung tumors in humans, because human lungs contain far fewer of Clara cells than rats or mice, and human lung microsomes failed to metabolize these compounds, which make humans much less sensitive to toxicity due to reactive metabolites.

TL;DR: This work used a similar procedure, with judicious selection of pertinent values, to obtain a TDI of 0.0081, lower than the US Food and Drug Administration's (USFDA) value, to alert the international community.

TL;DR: These values may be used as screening tools for evaluation of biomonitoring data for metabolites of these three phthalate compounds in the context of existing risk assessments and for prioritization of the potential need for additional risk assessment efforts for each of these compounds relative to other chemicals.

TL;DR: It is demonstrated that the Cry34Ab1 and Cry35Ab1 proteins do not represent a risk to human health and support previous studies indicating that 59122 maize grain is as safe and wholesome as non-GM maize grain.

TL;DR: Chinese herbal injections should be used only in cases involving severe disease or to rescue patients in critical condition and should not be used to treat mild, relatively innocuous diseases, such as common colds and upper respiratory tract infections, given the risk of doing harm.

TL;DR: The basic components of the FDA's decision-making process for evaluating the safety of new food additives are reviewed, and characteristics of this process that are central to assuring that FDA's decisions are marked by scientific rigor and high integrity are identified.

TL;DR: The colonization barrier disruption effect of ciprofloxacin, flavomycin, olaquindox and colistin sulfate is investigated by the minimum inhibitory concentration (MIC) assay in pure culture of human gut bacteria and the no-observed-effect-concentration (NOEC) and acceptable daily intake (ADI) based on the microbiological impact are evaluated.