ABSTRACT
At the time of the introduction of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety pharmacology guidance (S7 A&B), there was signi˜cant dissent over the “pivotal” organ systems that were required to be assessed before human exposure to a new drug, not including the immune system. Like the three organ systems that are listed in S7 as primary (cardiovascular, respiratory, and central nervous system, or CNS), transitory pharmacology effects on the immune system can also be acutely life-threatening (as demonstrated in 2006 with the CD28-Mab, TGNI-412), and its exclusion caused some dismay.
