Search results with tag "Ich harmonised tripartite uideline"

ICH HARMONISED TRIPARTITE UIDELINE

where clinical safety data are presented (e.g., relevant sections of the CTD 2.5.5 and 2.7.4). Discussion of risk factors and potential mechanisms that apply to identified AEs/ADRs should draw on information from any part of the CTD (non-clinical and clinical) and

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