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.

Type

Book

Intellectual base

Review or monograph

Year

2005

Link

https://openlibrary.org/works/OL18401947Wmatched

Cited from

pharmacology_toxicology

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.

Domain-specific

• NOAEL (No Observed Adverse Effect Level)
  • Following FDA guidance, sponsors take the NOAEL from the most sensitive relevant animal species, convert it to a human equivalent dose by body-surface-area scaling, then divide by a safety factor (default 10) to set the maximum recommended starting dose

Verification

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