Adaptive Licensing¶
Eichler, H., Oye, K., Baird, L. G., Abadie, E., Brown, J., L Drum, C., Ferguson, J., et al. (2012). Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval. Clinical Pharmacology & Therapeutics, 91(3), 426-437.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Collingridge Dilemma
- Regulators bend the curves with the prime's exact toolkit: conditional/adaptive approval with mandatory post-marketing surveillance (Phase IV) accelerates the information curve through structured monitoring, while staged rollout (restricted initial indications, gradual label expansion) slows the lock-in curve by limiting exposure until evidence accumulates — the medical analogue of a canary deployment.
This sourceProposes adaptive/staged licensing with iterative evidence-gathering and post-marketing surveillance — curve-bending (accelerate learning, slow exposure) against the population-exposure dilemma.
Supported in partVerified against the work's full text
Eichler et al. propose restricted initial licensing, progressive broadening of the labelled population and continued surveillance, but never use Phase IV, curve or canary framings, and describe a proposal, not current practice.
“initial licensing for use in a restricted population by a restricted number/group of physicians based on the issues that surround a given product and the level of knowledge generation at the point in the product's life when an initial authorization would be undertaken”
- Regulators bend the curves with the prime's exact toolkit: conditional/adaptive approval with mandatory post-marketing surveillance (Phase IV) accelerates the information curve through structured monitoring, while staged rollout (restricted initial indications, gradual label expansion) slows the lock-in curve by limiting exposure until evidence accumulates — the medical analogue of a canary deployment.
Verification¶
Does it exist? Confirmed. This work's DOI resolves to a registered record, which fixes its identity. That is all it fixes.
Does it back the claim? Read against the text for 1 of 1 citation: 1 supported in part. Each verdict is shown under its citation below, with what in the work backs the sentence.
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:429ce33cdded · see in the full table