5. Protocols
The development of new estimation methods in MNLEMs and their implementation in software now facilitate the analysis of longitudinal pharmacological data. However, the choice of experimental protocol remains a fundamental and complex issue. In this section, we review the definition of an experimental protocol, then introduce the current methodology for evaluating and optimizing protocols. Finally, we describe the existing IT tools and use one of them to determine new protocols based on the example of warfarin data.
5.1 Sampling protocols
The population protocol Ξ is composed of the N so-called elementary protocols ξ i (i = 1...N ) carried out in each of the study subjects. An elementary protocol ξ ...
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Conclusion and outlook
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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