Model-based analyses of bioequivalence crossover trials using the stochastic approximation expectation maximisation algorithm
Author:
Affiliation:
1. INSERM UMR738, University Diderot Paris 7; Paris France
2. INRIA Saclay; Orsay France
3. Modeling and Simulation Department Novartis Pharma AG; Basel Switzerland
Publisher
Wiley
Subject
Statistics and Probability,Epidemiology
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/sim.4286/fullpdf
Reference48 articles.
1. FDA Guidance for industry - statistical approaches to establishing bioequivalence Technical report 2001
2. EMEA Note for guidance on the investigation of bioavailability and bioequivalence Technical report 2001
3. Bioequivalence Studies in Drug Development
4. Bioequivalence tests based on individual estimates using non compartmental or model-based analyses: evaluation of estimates of sample means and type I error for different designs;Dubois;Pharmaceutical Research,2010
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