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4. Model building and evaluation
Model building in a pharmacometrics analysis requires proposed models to be evaluated, and compared statistically. In this section, we present the inference and diagnostic tools used to conduct this decision-making process .
4.1 Inference
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Maximum likelihood inference
In regression, the classic inference tests are the likelihood ratio test (LRT), the Wald test and the score test. In MNLEM, the LRT, Wald test and statistical criteria such as the Akaike criterion are most often used....
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Model building and evaluation
Protocols
Bibliography
Software tools
R Development Core Team 2008 R : A language and environment for statistical computing, [software].
Lixoft SAS 2013 Monolix, [software]. Incuballiance, 86 rue de Paris, 91400 Orsay, France.
Icon Development Solutions 2009 NONMEM, [software]. Icon Development Solutions, Ellicott City, MD, USA.
Foundation for Statistical Computing, Vienna, Austria....
Websites
DDMoRe European Consortium on Disease and Drug Modeling http://www.ddmore.eu/
EMA European Medicines Agency http://www.ema.europa.eu/
FDA Food and Drug Administration http://www.fda.gov
...Events
Conference: American Conference on Pharmacometrix (ACOP) http://www.go-acop.org/
Conference: Population Approach Group in Australia and New Zealand (PAGANZ) http://www.paganz.org
Conference: Population Approach Group in Europe (PAGE). Held annually...
Standards and norms
Food and Drug Administration (FDA). – Guidance for industry: population pharmacokinetics (1999) http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM133184.pdf
European Medicines Agency (EMEA). – Guideline on reporting the...
Regulations
Food and Drug Administration (FDA), U.S. regulatory agency http://www.fda.gov/
European Medicines Agency (EMEA), European regulatory agency http://www.ema.europa.eu/ema/
French National Agency for the Safety of Medicines and Health Products...
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