Interactive FDA Presentation on Exploratory Investigational New Drug (IND) Requirements

Venue: Online

Location: Online, Pennsylvania, United States

Event Date/Time: Sep 15, 2006 End Date/Time: Sep 15, 2006
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Description

WEBINAR HIGHLIGHTS:
•Overview of the chemistry and pharmacology requirements associated with exploratory IND.
•Tips to help you efficiently develop promising drug and biologic candidates while maintaining the safety of human subjects.
•Presentation of the necessary preclinical and clinical approaches and CMC information to be considered when planning
Exploratory studies in humans, including studies of closely-related drugs or therapeutic biological products under an Investigational New Drug (IND) application (21 CFR 312).

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