Applying Physiological and Biochemical Concepts to Optimize Biological Drug Development

Posology—the science of dose and regimen—is a critical part of drug development. It is concerned with ensuring that patients experience significant clinical benefit without intolerable adverse effects. It has become apparent, in the case of certain biologics, that one can directly quantitate occupan...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2010-04, Vol.87 (4), p.492-496
Main Author: Lowe, PJ
Format: Article
Language:English
Subjects:
Biological and medical sciences
Biological Products - administration & dosage
Biological Products - adverse effects
Biological Products - pharmacology
Clinical Trials as Topic - methods
Computer Simulation
Dose-Response Relationship, Drug
Drug Design
Humans
Medical sciences
Models, Biological
Pharmacology. Drug treatments
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Summary:Posology—the science of dose and regimen—is a critical part of drug development. It is concerned with ensuring that patients experience significant clinical benefit without intolerable adverse effects. It has become apparent, in the case of certain biologics, that one can directly quantitate occupancy or target capture and relate these to clinical responses. With mathematical models that integrate binding concepts with clinical effects, potential posologies can be quickly explored through simulation, thereby liberating research teams from the traditional constraints and simultaneously stimulating innovation.
ISSN:0009-9236
1532-6535
DOI:10.1038/clpt.2009.302