Presentation: “What Pharmacometrics Processes Need to Be Standardized? And How?”

Expert Panel: Dr. Kevin Dykstra, QPharmetra, Dr. Jeff Barrett, Sanofi ,Dr. Nitin Mehrotra (pending approval), US FDA

Date: Thursday, March 27, 2014

Location: Bridgewater Manor, Bridgewater NJ

Agenda:
- Reception/Networking Session 5:30-6:30 pm
- Scientific Discussion: 6:30 - 7:30 pm
- Dinner 7:30-8:45 pm
- Closing Remarks 8:45 – 9:00

 

Cost:
Discussion and Dinner

ISoP Member                    $35/$45
Non-ISoP Member         $45/$55

Discussion Only
ISoP Member                    $20/25
Non- ISoP Member         $25/35
Early-Bird pricing available til March 17th, 2014

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Abstract

There has been a recent heightened interest in definition and articulation of “standards” for pharmacometric analysis and reporting. This development represents progress, in that the focus on quality and reproducibility reflects the increasing maturity of the field and the importance attached to pharmacometric analysis results. It is easy to recognize that standardized methods and reporting formats can greatly enhance the efficiency of producing and evaluating the results emerging from a given modeling effort. However, the fact remains that many aspects of pharmacometric analysis are resistant to standardization because of the multi-faceted nature of the problems, the variety of tools that can be applied, and the essentially creative nature of the model-building process. This session is intended to explore where the balance of benefit lies in weighing the implementation of strict standardization against the preservation of “artistic freedom” for the modeler to explore non-standard methods that may be appropriate for a given analysis.   In addition to panel presentations, audience participation and discussion is expected and encouraged.