Development needs management paradigms

Current pharmacometrics practices and available techniques for model-based development are heavily constrained by a vision of model-based development as a subsidiary development process in an empirical development paradigm. Many of the symptoms of the less than optimal functioning of pharmacometrics in this setting are the result of a failure to appreciate the true needs and requirements of the pharmacometrics group. In this chapter, we use the term pharmacometrics enterprise to denote the need to transform the current pharmacometrics analysis process to an interdependent enterprise capable of managing the growing complexity of the critical upstream and downstream implications of a fully functional and accountable service. The design of a pharmacometrics enterprise that embodies the required elements is a novel and complex endeavor that can overtax the experience and... 

---