Questions and answers on the withdrawal of the 'Note for guidance on single dose toxicity'
|Keywords||Single dose toxicity, acute toxicity, timing on non-clinical studies|
|Description||This document aims to clarify how to obtain information on acute toxicity from sources other than traditional single dose toxicity studies.|
- ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals
- ICH S7A Safety pharmacology studies for human pharmaceuticals
- ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals
- ICH S9 Non-clinical evaluation for anticancer pharmaceuticals
- Repeated dose toxicity