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Preclinical safety testing There are numerous references, as well as guidance documents for developing preclinical safety programs to support an FIH trial.2, 3, 4, 5 In particular, the International Conference on Harmonization (ICH) M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals provides recommendations of what ICH regulatory authorities expect for a safety evaluation program to enable an FIH trial.6 Additional information on requirements specific for biotechnologyderived pharmaceuticals (biologics) are provided in ICH S6(R1)7 and guidance related to nonclinical evaluation for anticancer pharmaceuticals are provided in ICH S9.8 This background of regulatory expectations is helpful to keep in mind in developing a preclinical safety testing strategy tailored for the particular needs of a drug development program (i.e., modality and indication)