Relevance of the 1-year dog study in assessing human health risks for registration of pesticides. An update to include pesticides registered in Japan.

Over 400 active pesticides are registered in Japan (FAMIC 2013). The results of dog toxicity studies (usually, the 1-year study) were used by the Japanese regulatory authorities to establish the acceptable daily intake (ADI) for 45 pesticide active ingredients (about 9%). A retrospective review of ADIs established in Japan with dog studies as pivotal data for their derivation was performed: the ADIs were reassessed under the assumption that the 1-year dog study would not be available and an alternate ADI was derived based on the remaining toxicology database.

Critical evaluation of the use of dogs in biomedical research and testing in Europe.

Dogs are sometimes referred to as "man's best friend" and with the increase in urbanization and lifestyle changes, dogs are seen by their owners as family members. Society expresses specific concerns about the experimental use of dogs, as they are sometimes perceived to have a special status for humans. This may appear somewhat conflicting with the idea that the intrinsic value of all animals is the same, and that also several other animal species are used in biomedical research and toxicology.

Overall impact of the regulatory requirements for genotoxic impurities on the drug development process.

In the last decade a considerable effort has been made both by the regulators and the pharmaceutical industry to assess genotoxic impurities (GTI) in pharmaceutical products. Though the control of impurities in drug substances and products is a well established and consolidated procedure, its extension to GTI has given rise to a number of problems, both in terms of setting the limits and detecting these impurities in pharmaceutical products. Several papers have dealt with this issue, discussing available regulations, providing strategies to evaluate the genotoxic potential of chemical substances, and trying to address the analytical challenge of detecting GTI at trace levels.

A 1-year toxicity study in dogs is no longer a scientifically justifiable core data requirement for the safety assessment of pesticides.

A review of publications on pesticides assessing the need for 1-year toxicity studies in dogs was performed. Four key peer-reviewed papers with different approaches investigated the value of a 1-year dog study in addition to a 3-month study. Despite different databases and approaches, each concluded with the recommendation to limit the testing of pesticides in dogs to a duration of 3 months.

Chemistry and biology of thiamethoxam: a second generation neonicotinoid.

Thiamethoxam is the first commercial neonicotinoid insecticide from the thianicotinyl subclass. It was discovered in the course of our optimisation program on neonicotinoids started in 1985. Novel variations of the nitroimino-heterocycle of imidacloprid led to 4-nitroimino-1,3,5-oxadiazinanes exhibiting high insecticidal activity.