Many medicinal plants with therapeutic potentials have toxicity. Is it possible to study known toxic botanicals?
Yes, in some cases this can be done. The CDER review division will evaluate the known risk and the potential benefit of an investigational new drug in the proposed study. When the potential benefit of an investigational drug outweighs its risk in the studied patient population, an IND is often allowed. For example, a relatively higher level of toxicity of an investigational drug used in a study of terminally-ill cancer patients may be acceptable.
