Non-clinical safety assessment of antibodies for development in the United States and in Europe

抄録

ICH guidelines are available for all major steps of the non-clinical safety assessment of biologics, which includes therapeutic antibodies. In so far the development world could be simple – sponsors have just to follow the written recipes to bring their drugs through the process of non-clinical safety testing!? However, guidelines as well as international drug laws ask for scientifically sound testing as well as evaluation of drug candidates using state-of-the-art methods. Further, the regulatory practice and experience with other drugs under development may lead to additional requirements. All these emerging testing paradigms are considered essential to assure the highest safety standards for patients, but they also make preclinical safety scientists’ life interesting. Practice and challenges for non-clinical safety testing programs for antibodies under development in the US and in Europe will be presented and discussed. Examples of recent experiences US companies gained during the regulatory process will be presented as well. Depending on its availability a guideline for the development of biologics announced by the US FDA may be discussed.