Points To Consider When Presenting Population Analysis To Regulatory Autorities.

Jean-Louis Steimer

Sandoz Pharma, Drug Safety, 751/306, CH-4002 Basel

The presentation will be based on points to consider when submitting population analysis to regulatory authorities within a New Drug Application, as presented by Dr T. Ludden (Head of Biopharmaceutics, CDER, FDA) within the Round-Table “Population Approaches (NONMEM) : Practical Experiences” at the AAPS Meeting in San Antonio, Nov 1992. The points include : logistical concerns, description of data, checks for reliability of results, and provision of information helpful for the evaluation of population analysis.

Reference: PAGE 2 () Abstr 915 [www.page-meeting.org/?abstract=915]

Poster: oral presentation