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1. Data
1.1 Longitudinal data
Longitudinal data are data measured repeatedly in the same subject, inducing correlation between observations. In pharmacometrics, these data are obtained during clinical drug trials. They are collected from all subjects several times over time, during different treatment periods (occasions); their number may differ from one subject and/or occasion to another. The data collected has a hierarchical structure: observations can be grouped together as belonging to the same entity, the subject or individual. Each subject is different, with specific PK and/or PD parameters and therefore different from those of the population, i.e. the "average" subject. For each subject, demographic, genetic, physiological and environmental factors are collected. Called covariates,...
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Data
Non-linear mixed-effects models
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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