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STATISTICAL ANALYSIS OF TIME TO EVENT DATA FROM PRECLINICAL SAFETY PHARMACOLOGY STUDIES |
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| Authors: | Helle Andersen Henrik Spliid Søren Larsen Vivi Dall |
| Affiliation: | 1. Department of Mathematical Modelling, Technical University of Denmark, Lyngby, Denmark, and Novo Nordisk A/S, Novo Allé, Bagsvaerd, Denmarkha@imm.dtu.dk;3. Department of Mathematical Modelling, Technical University of Denmark, Lyngby, Denmark;4. Novo Nordisk A/S, Novo Allé, Bagsvaerd, Denmark |
| Abstract: | We describe and discuss parametric models for statistical analysis of safety pharmacology studies in which the response is time to some event. The event is a qualitative change situated in time. The models include possible censoring which can be caused by end of study before the event has occurred or death of the animal before end of study, for example. The models proposed in this article include covariates that do not depend on time. The presentationis accompanied by case studies analyzed by the SAS procedure LifeReg. |
| Keywords: | Censoring Preclinical Development Safety Pharmacology Studies Statistical Analysis Survival Analysis |