Prediction of Clinical Irrelevance of PK Differences in Atorvastatin Using PK/PD Models Derived From Literature-Based Meta-Analyses
To support the development of a fixed-dose combination (FDC) of ezetimibe and atorvastatin for the treatment of dyslipidemia, bioequivalence (BE) studies were conducted across a combined dose range (10/10, 10/20, 10/40, and 10/80 mg of ezetimibe/atorvastatin). In the BE trials, all parameters met tr...
Main Authors: | , , , , |
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Format: | Online |
Language: | English |
Published: |
Nature Publishing Group
2014
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Online Access: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4062834/ |