Sepsis Syndrome and Associated Sequelae in Patients at High Risk for Gram‐Negative Sepsis

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/90154/1/j.1875-9114.1995.tb04333.x.pd

Challenges in the transition to model-based development

Practitioners of the art and science of pharmacometrics are well aware of the considerable effort required to successfully complete modeling and simulation activities for drug development programs. This is particularly true because of the current, ad hoc implementation wherein modeling and simulation activities are piggybacked onto traditional development programs. This effort, coupled with the failure to explicitly design development programs around modeling and simulation, will continue to be an important obstacle, to the successful transition to model-based drug development. Challenges with timely data availability, high data discard rates, delays in completing modeling and simulation activities, and resistance of development teams to the use of modeling and simulation in decision making are all symptoms of an immature process capability for performing modeling and simulation