Document Detail

Evaluating assumptions for least squares analysis using the general linear model: a guide for the pharmaceutical industry statistician.
MedLine Citation:
PMID:  15468766     Owner:  NLM     Status:  MEDLINE    
A review of graphical and test based methods for evaluating assumptions underlying the use of least squares analysis with the general linear model is presented along with some discussion of robustness. Alternative analyses are described for situations where there is evidence that the assumptions are not reasonable. Evaluation of the assumptions is illustrated through the use of an example from a clinical trial used for US registration purposes. It is recommended that: (1) most assumptions required for the least squares analysis of data using the general linear model can be judged using residuals graphically without the need for formal testing, (2) it is more important to normalize data or to use nonparametric methods when there is heterogeneous variance between treatment groups, and (3) nonparametric analyses can be used to demonstrate robustness of results and that it is best to specify these analyses prior to unblinding.
Patrick F Darken
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of biopharmaceutical statistics     Volume:  14     ISSN:  1054-3406     ISO Abbreviation:  J Biopharm Stat     Publication Date:  2004 Aug 
Date Detail:
Created Date:  2004-10-07     Completed Date:  2005-01-26     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9200436     Medline TA:  J Biopharm Stat     Country:  United States    
Other Details:
Languages:  eng     Pagination:  803-16     Citation Subset:  IM    
ALTANA Pharma US, Florham Park, New Jersey 07932, USA.
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MeSH Terms
Aging / physiology
Albuterol / analogs & derivatives*,  therapeutic use
Androstadienes / therapeutic use
Bronchodilator Agents / therapeutic use
Data Interpretation, Statistical
Drug Industry / statistics & numerical data*
Forced Expiratory Volume
Least-Squares Analysis*
Linear Models*
Pulmonary Disease, Chronic Obstructive / drug therapy
Research Design / legislation & jurisprudence,  statistics & numerical data
United States
Reg. No./Substance:
0/Androstadienes; 0/Bronchodilator Agents; 18559-94-9/Albuterol; 89365-50-4/salmeterol; 90566-53-3/fluticasone

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

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