Module 9 2024

05/09/2024

NON CLINICAL DATA REQUIREMENTS

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Non-Clinical Data

Need for in vivo data based on tiered risk based approach Generally require only in vitro data Need for in vivo data often questioned

In vitro data generally not considered in non clinical section In vivo data required if first in humans studies to be done in US Existence of clinical data may eliminate need for non clinical data

Some other jurisdictions require more comprehensive non clinical data e.g. India, Japan, China.

The Organisation for Professionals in Regulatory Affairs

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