GUIDANCE ON NONCLINICAL SAFETY STUDIES FOR THE CONDUCT OF HUMAN CLINICAL TRIALS AND MARKETING AUTHOR

The purpose of this document is to recommend international standards for , and promote harmonisation of .The nonclinical safety studies recommended to support human clinical trials of a given scope and duration as well as marketing authorization for pharmaceuticals .Five different examples of exploratory clinical approaches are summarized below and in more detail in Table 3 , together with the nonclinical testing programs that would be recommended in these particular approaches .