Investigational New Drug (IND) Application" / 21 CFR Part 312¶
U.S. Food and Drug Administration. Investigational New Drug (IND) Application" / 21 CFR Part 312.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Innovation Sandbox
- A Phase-I drug trial is structurally identical in medicine: the host is the eventual patient population of millions; the enclosure is a tightly monitored unit of perhaps twenty healthy volunteers; the permissive rule-set licenses giving humans an untested compound; the blast-radius cap is the small, closely observed cohort with rapid-stop rules; learning flows out as safety and pharmacokinetic data while the consequence — general prescription — is gated behind Phase II/III terminal reviews.
This sourceDefines phased clinical trials, where a Phase I study in a small monitored cohort gates promotion toward general use through subsequent reviews.
- A Phase-I drug trial is structurally identical in medicine: the host is the eventual patient population of millions; the enclosure is a tightly monitored unit of perhaps twenty healthy volunteers; the permissive rule-set licenses giving humans an untested compound; the blast-radius cap is the small, closely observed cohort with rapid-stop rules; learning flows out as safety and pharmacokinetic data while the consequence — general prescription — is gated behind Phase II/III terminal reviews.
Verification¶
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