Document Detail

Strategic use of statistical thinking in drug development.
MedLine Citation:
PMID:  11113955     Owner:  NLM     Status:  MEDLINE    
The role of the statistician and statistical thinking in the pharmaceutical industry has evolved greatly in the last four or five decades. Regulatory developments and the changing face of the science of drug development have driven this evolution. The increasing regulatory requirement for statistical input in critical areas has facilitated a wider range of applications. The pace of change of science in general has brought statisticians into contact with a wider range of potential customers. More importantly, it has allowed the statistician to become increasingly involved in strategic issues with the possibility of influencing the direction of the business. However, it is not clear that the statistical profession in industry is adequately prepared for these opportunities either in attitude or training. Changing the statisticians' approach to their role and acquiring the correct training and experience are critical for the profession to optimize their contribution to the drug discovery and development processes.
F W Rockhold
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Statistics in medicine     Volume:  19     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:  2000 Dec 
Date Detail:
Created Date:  2001-01-26     Completed Date:  2001-05-10     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  3211-7     Citation Subset:  IM    
SmithKline Beecham Pharmaceuticals, Resear and Development, 1250 South Collegeville Road, P.O. Box 5089, Collegeville, PA 19426-0989, USA.
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MeSH Terms
Drug Approval
Drug Design*
Drug Industry*
Statistics as Topic*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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