Probabilistic Risk Analysis: Improving Early Drug Development Decision Making

Model‐based drug development (MBDD) is advocated by industry, academia, and regulatory agencies as a powerful tool to improve the efficiency of drug development. Clinical pharmacologists play key roles in implementing MBDD because of their ability to integrate mechanistic, preclinical, and clinical...

Full description

Saved in:
Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2010-12, Vol.88 (6), p.871-875
Main Authors: Mudd, P N, Groenendaal, H, Bush, M A, Schmith, V D
Format: Article
Language:English
Subjects:
Animals
Biological and medical sciences
Decision Making, Organizational
Drug Discovery - methods
Drug Discovery - trends
Humans
Medical sciences
Models, Statistical
Pharmacology. Drug treatments
Risk Assessment - methods
Risk Assessment - trends
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Model‐based drug development (MBDD) is advocated by industry, academia, and regulatory agencies as a powerful tool to improve the efficiency of drug development. Clinical pharmacologists play key roles in implementing MBDD because of their ability to integrate mechanistic, preclinical, and clinical information, using quantitative approaches to address the complex questions arising during drug development. Use of probabilistic risk analysis (PRA) approaches (e.g., value of information, combining uncertain information, and modeling expert opinion) can improve the implementation of MBDD. Clinical Pharmacology & Therapeutics (2010) 88 6, 871–875. doi: 10.1038/clpt.2010.231
ISSN:0009-9236
1532-6535
DOI:10.1038/clpt.2010.231