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Search results with tag "Nonclinical testing"
NONCLINICAL SAFETY TESTING IN SUPPORT OF …
database.ich.orgnonclinical testing and its timing should be based upon a thoroughrisk -benefit evaluation. In these conditions, if a safety concern is identified as new information is generated, appropriate nonclinical studies should be considered, and could be conducted in parallel with potentially ongoing paediatric clinical investigations.
Nonclinical Safety Studies for the Conduct of Human ...
database.ich.orgnonclinical safety studies to support human clinical trials of a given scope and duration, and for the marketing authorization of drug products. Scope of Revisions to ICHM3(R1) (a) ... studies with nonclinical testing program directed only to support those early exploratory approaches