In the area of repeated-dose safety studies, agreement was reached on the questions of delayed toxicity and appropriate dosing levels as well as on the reduction from 12 to 6 months of duration for long-term studies. - 2 - By limiting repeated dose toxicity studies to six rather than 12 months, as many as 200 rats and 48 dogs less per new active substance will be required to demonstrate safety.
- 2 - Ferner einigte man sich darauf, die Dauer der Versuche zur chronischen Toxizitaet von 12 auf 6 Monate zu senken; das heisst, rund 200 Ratten und 48 Hunde weniger werden benoetigt, um die Sicherheit jedes neuen Wirkstoffs zu pruefen. Weltweit werden jaehrlich rund 60 neue Stoffe entwickelt.