Learning versus confirming in clinical drug development¶
Sheiner, L. B. (1997). Learning versus confirming in clinical drug development. Clinical Pharmacology & Therapeutics, 61(3), 275-291.
Cited by¶
2 citations across 2 artifacts.
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Primes¶
- Dose-Response Relationship
- This formal machinery is the foundation of the model-based, "learn-and-confirm" approach to rational drug design that Sheiner (1997) advocated as a substitute for purely empirical dose-finding in clinical pharmacology.
This sourceArgues for a model-based learn-and-confirm cycle using dose-response/PK-PD models to design dose-finding studies; supports D47-029 (the Hill equation as the formal scaffolding of rational drug design, not purely empirical curve-fitting).
- This formal machinery is the foundation of the model-based, "learn-and-confirm" approach to rational drug design that Sheiner (1997) advocated as a substitute for purely empirical dose-finding in clinical pharmacology.
- PK/PD Modeling (Pharmacokinetics / Pharmacodynamics)
- PK/PD is clarifying because it integrates disparate quantitative findings about a drug — absorption rate, distribution volume, elimination rate, target affinity, signal transduction, clinical endpoint — into a unified mathematical framework that predicts the clinical time course from dose, an integrative role Sheiner (1997) articulated in his "Learning versus Confirming" framing of clinical drug development.
This sourceArgues for a model-based "learn-and-confirm" cycle in drug development that uses dose-response and PK/PD models to design dose-finding studies; reframes the Hill equation as the formal scaffolding of rational drug design rather than purely empirical curve-fitting.
- PK/PD is clarifying because it integrates disparate quantitative findings about a drug — absorption rate, distribution volume, elimination rate, target affinity, signal transduction, clinical endpoint — into a unified mathematical framework that predicts the clinical time course from dose, an integrative role Sheiner (1997) articulated in his "Learning versus Confirming" framing of clinical drug development.
Verification¶
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