Basic principles of non-clinical development

7. First dose estimation in human

It is important to estimate the first dose to be used in first-in-human studies (phase I) in order to protect the study participants.

All relevant non-clinical data should be considered but NOAEL gives the most important information.

For exploratory clinical studies in humans, the dose can be estimated on less or different non-clinical data. The criteria that are used to find the start dose are part of the regulatory guidelines (ICH guidelines M3(R2) – EMA/CPMP/ICH/286/1995).