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| | Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies |
 | | Because exploratory IND studies involve administering either sub-pharmacologic doses of a product, or doses expected to produce a pharmacologic, but not a toxic, effect, the potential risk to human subjects is less than for a traditional phase 1 study that, for example, seeks to establish a maximally tolerated dose. |
 | | The exploratory IND studies discussed here focus on a circumscribed study or group of studies, and plans for further development cannot be formulated without the results of these studies. |
 | | Therefore, an exploratory IND application should articulate the rationale for selecting a compound (or compounds) and for studying them in a single trial or related trials, as this represents all that is known about the overall development plan at this stage. |
| www.fda.gov /cder/guidance/7086fnl.htm (5328 words) |
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