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. 2007 Apr 10;64(3):266–277. doi: 10.1111/j.1365-2125.2007.02887.x

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© 2007 The Authors Journal compilation © 2007 Blackwell Publishing Ltd

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The difference in number of adverse events vs. the size of therapeutic interval (TI = TC₅₀/EC₅₀) between a randomized dose-controlled trial (RDCT) with model-based analysis (MBA) with biomarker as independent variable and a randomized concentration-controlled trial (RCCT) with group-wise analysis. The graphs are conditioned on variability in (a) TC₅₀ (, 0 varCL; , 0.2 varCL; , 0.3 varCL; , 0.5 varCL; , 0 varTC50) and (b) CL (, 0 varTC50; , 0.3 varTC50; , 0.5 varTC50; , 0.75 varTC50; , 1 varTC50). The variability is noted as the CV.

Inline graphic — The difference in number of adverse events vs. the size of therapeutic interval (TI = TC₅₀/EC₅₀) between a randomized dose-controlled trial (RDCT) with model-based analysis (MBA) with biomarker as independent variable and a randomized concentration-controlled trial (RCCT) with group-wise analysis. The graphs are conditioned on variability in (a) TC₅₀ (, 0 varCL; , 0.2 varCL; , 0.3 varCL; , 0.5 varCL; , 0 varTC50) and (b) CL (, 0 varTC50; , 0.3 varTC50; , 0.5 varTC50; , 0.75 varTC50; , 1 varTC50). The variability is noted as the CV.