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A dose that is unlikely to cause an adverse effect in an individual if exposed, by any route, at or below this dose every day for a lifetime. By definition The ADE is protective of all populations by all routes of administration. Normally, the ADE should be based on studies using the same route that it will be applied to evaluate. When this is not possible, and an ADE is required, proper professional should be engaged (toxicologists) to provide a sound scientific rationale to support application to a different route. Only then can the ADE be adjusted to extrapolate between routes which may result in a lower or higher value. As additional information becomes available, the ADE value should be reviewed and revised if necessary.
Publication Source: ISPE Baseline® Guide, Vol. 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
Publication Date: 2010
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