<P> An IND is required for a clinical study if it is intended to support a: </P> <Ul> <Li> New indication </Li> <Li> Change in the approved route of administration or dosage level </Li> <Li> Change in the approved patient population (e.g. pediatric) or a population at greater or increase of risk (elderly, HIV positive, immunocompromised) </Li> <Li> Significant change in the promotion of an approved drug </Li> </Ul> <Li> Change in the approved route of administration or dosage level </Li> <Li> Change in the approved patient population (e.g. pediatric) or a population at greater or increase of risk (elderly, HIV positive, immunocompromised) </Li>

The investigational new drug ind application contains which of the following information