JSM 2004 - Toronto

Abstract #300817

This is the preliminary program for the 2004 Joint Statistical Meetings in Toronto, Canada. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2004); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

To View the Program:
You may choose to view all activities of the program or just parts of it at any one time. All activities are arranged by date and time.

The views expressed here are those of the individual authors
and not necessarily those of the ASA or its board, officers, or staff.

Back to main JSM 2004 Program page
Activity Number: 380
Type: Contributed
Date/Time: Wednesday, August 11, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300817
Title: Statistical Issues in Toxicology Cardiovascular Safety Pharmacology Studies
Author(s): Alan Y. Chiang*+
Companies: Eli Lilly and Company
Address: Greenfield Research Laboratories, DC #GL43, Greenfield, IN, 46140,
Keywords: toxicology ; safety pharmacology ; design ; power evaluation
Abstract:

The goal of safety pharmacology studies is to investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above. The cardiovascular system is one of the vital organ systems acutely critical for life and, therefore, most important. General recommendations for testing strategies in nonclinical studies include: in-vivo evaluation of blood pressure, heart rate, and the electrocardiogram, and in-vitro analysis of ionic current assays and repolarization assays. This talk focuses on some of the key statistical issues, including design, power evaluation, and data analysis, in toxicology cardiovascular safety pharmacology studies. Statistical considerations arisen from ICH S7A and S7B guidance documents for nonclinical studies will also be discussed.

  • The address information is for the authors that have a + after their name.
  • Authors who are presenting talks have a * after their name.

Back to the full JSM 2004 program

JSM 2004 For information, contact jsm@amstat.org or phone (888) 231-3473. If you have questions about the Continuing Education program, please contact the Education Department.
Revised March 2004