Zdrowie i gospodarka · 25/06/1999

FDA Publishes Guidance on Chronic Toxicity Testing Duration

The Food and Drug Administration (FDA) is publishing a guidance document titled 'S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)' which provides guidance on the duration of chronic toxicity testing in rodents and nonrodents as part of the safety evaluation of a drug product. The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).