Confirmatory analysis for phase III population pharmacokinetics.

  title={Confirmatory analysis for phase III population pharmacokinetics.},
  author={Chuanpu Hu and Ji Zhang and Honghui Zhou},
  journal={Pharmaceutical statistics},
  volume={10 1},
Population pharmacokinetics (POPPK) has many important uses at various stages of drug development and approval. At the phase III stage, one of the major uses of POPPK is to identify covariate influences on human pharmacokinetics, which is important for potential dose adjustment and drug labeling. One common analysis approach is nonlinear mixed-effect modeling, which typically involves time-consuming extensive search for best fits among a large number of possible models. We propose that the… CONTINUE READING