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.
- 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¶
This reference passed the adversarial substantiation pipeline: it was checked to exist and to support the claim it is attached to. See how references were verified.
Registry ID ref:429ce33cdded · see in the full table