1.6.4 ICH S-Series and M3(R2)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use publishes the S-series of safety guidelines,...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use publishes the S-series of safety guidelines, spanning genotoxicity (S2), carcinogenicity (S1), reproductive toxicity (S5), and safety pharmacology (S7A/S7B). ICH M3(R2) is of particular practical importance because it specifies the timing and duration of non-clinical safety studies relative to the corresponding phase of human clinical development, ensuring that adequate animal safety data exist before each incremental increase in human exposure.