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Probabilistic Risk Analysis: Improving Early Drug Development Decision Making
Author(s) -
Mudd P N,
Groenendaal H,
Bush M A,
Schmith V D
Publication year - 2010
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2010.231
Subject(s) - drug development , clinical pharmacology , probabilistic logic , risk analysis (engineering) , expert opinion , drug , key (lock) , probabilistic risk assessment , computer science , pharmaceutical industry , management science , medicine , pharmacology , intensive care medicine , artificial intelligence , engineering , computer security
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