Model-informed drug development¶
Wang, Zhu, Madabushi, Liu, Huang, & Zineh. (2019). Model-informed drug development: Current US regulatory practice and future considerations. Clinical Pharmacology & Therapeutics, 105(4), 899-911.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Primes¶
- PK/PD Modeling (Pharmacokinetics / Pharmacodynamics)
- T5: Regulatory and Practical Constraints on Optimization. PK/PD models may identify a dose regimen that is theoretically optimal for efficacy and safety but is impractical (too frequent dosing, requires continuous infusion, demands real-time monitoring) or commercially unviable (requires genetic testing, entails high per-patient cost, conflicts with standard-of-care expectations) — tensions explicitly addressed by the FDA's model-informed drug development (MIDD) framework as described by Wang and Hung (2017).
This sourceArticulates the regulatory and practical constraints on PK/PD-driven dose optimization within the FDA's MIDD framework.
- T5: Regulatory and Practical Constraints on Optimization. PK/PD models may identify a dose regimen that is theoretically optimal for efficacy and safety but is impractical (too frequent dosing, requires continuous infusion, demands real-time monitoring) or commercially unviable (requires genetic testing, entails high per-patient cost, conflicts with standard-of-care expectations) — tensions explicitly addressed by the FDA's model-informed drug development (MIDD) framework as described by Wang and Hung (2017).
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? Not recorded. The single citation of this work carries no recorded support check.
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.
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Registry ID ref:e5c07a132aab · see in the full table