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¶
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