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Model‐Based Drug Development Survey Finds Pharmacometrics Impacting Decision Making in the Pharmaceutical Industry
Author(s) -
Stone Julie A.,
Banfield Christopher,
Pfister Marc,
Tannenbaum Stacey,
Allerheiligen Sandy,
Wetherington Jeffrey D.,
Krishna Rajesh,
Grasela Dennis M.
Publication year - 2010
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270010377628
Subject(s) - drug development , pharmaceutical industry , pipeline (software) , business , risk analysis (engineering) , drug , marketing , computer science , medicine , pharmacology , programming language
During the past decade, the pharmaceutical industry has seen the increasing application of pharmacometrics approaches in drug development. However, the full potential of incorporating model‐based approaches in drug development and its impact on decision making has not been fully realized to date. In 2009, a survey on model‐based drug development (MBDD) was conducted (1) to further understand the current state of MBDD in the pharmaceutical industry and (2) to identify opportunities to realize the full potential of MBDD. Ten large and mid‐sized pharmaceutical companies provided responses to this survey. The results indicate that MBDD is achieving broad application in early and late development and is positively affecting both internal and regulatory decisions. Senior leadership (vice president and higher) within the companies indicated widely accepted utility for dose selection and gaining acceptance for study design and regulatory interactions but limited acceptance in discovery and commercial/pipeline decisions. Mounting appreciation for the impact of MBDD on internal and regulatory decision‐making bodes well for the future of the pharmacometric discipline and the growth of opportunities to realize the full potential of MBDD.