４．医薬品の毒性評価の考え方

抄録

Drugs have to be evaluated from a different viewpoint from other toxic substances such as natural toxins, environment substances and chemicals. Toxicological evaluations are also important to clarify the benefits and risks of pharmaceuticals to humans. Many of the toxicology studies are conducted according to guidelines. The type and timing of toxicology studies have been harmonized internationally. Recently, the ICH guidelines have been revised in light of technological advances and reduction of animal usage in accordance with the 3R (reduce/refine/replace) principle. The results of toxicology studies must always be evaluated based on extrapolation to humans. The goal of regulatory science is to predict a risk based on the latest information and evaluate safety. Even if the toxicological findings are similar, the toxicological acceptability assessment is not always the same. It is important that the toxicology for pharmaceutical products is evaluated on a case-by-case basis.