Guidance for Industry¶
Food, U. S., Drug Administration, C. f. D. E., & Research. (2005). Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.
Cited by¶
2 citations across 2 artifacts.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Therapeutic Window
- The upper bound (maximum tolerated dose) is often harder—toxicity may be delayed (cumulative organ damage), rare (requiring large sample sizes), or population-specific (children, elderly), and its dose-response is under-characterized until long after drug approval when post-market surveillance reveals harm; the FDA (2005) industry guidance on estimating the maximum safe starting dose codifies how this asymmetry is handled at the regulatory edge.
This sourceFDA. Codifies regulatory practice for setting the upper bound of the therapeutic window in first-in-human trials: NOAEL-based scaling, human-equivalent dose conversion, and safety-factor application that explicitly handle MTD-estimation asymmetry.
- The upper bound (maximum tolerated dose) is often harder—toxicity may be delayed (cumulative organ damage), rare (requiring large sample sizes), or population-specific (children, elderly), and its dose-response is under-characterized until long after drug approval when post-market surveillance reveals harm; the FDA (2005) industry guidance on estimating the maximum safe starting dose codifies how this asymmetry is handled at the regulatory edge.
Domain-specific¶
Verification¶
Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.
Does it back the claim? Read against the text for 1 of 2 citations: 1 supported. Each verdict is shown under its citation below, with what in the work backs the sentence.
Was it audited? Yes. A second, independent pass read the citation against the article text and recorded a verdict.
Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.
See how references were verified.
Registry ID ref:7e369e876196 · see in the full table