Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/9253
Title: Investigating Association Between Behavior, Corticosterone, Heart Rate, and Blood Pressure in Rats Using Surrogate Marker Evaluation Methodology
Authors: TILAHUN ESHETE, Abel 
MARINGWA, John 
GEYS, Helena 
ALONSO ABAD, Ariel 
Raeymaekers, Leen
MOLENBERGHS, Geert 
Van Den Kieboom, Gerd
Drinkenburg, Pim
BIJNENS, Luc 
Issue Date: 2009
Publisher: TAYLOR & FRANCIS INC
Source: JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 19(1). p. 133-149
Abstract: The drug development process involves identifying a compound and assessing its merit through rigorous pre-clinical and clinical trials. The pre-clinical stage is designed to assess the chemical properties of the new drug, as well as to determine the steps for synthesis and purification. In this stage of drug development, circumstances might dictate the use of alternative endpoints than the originally anticipated clinically relevant endpoint. In this regard, identification and evaluation of surrogate endpoints is of paramount importance. The validation methods make it possible to quantify degrees of association between the clinically relevant endpoint, also termed the true endpoint, and the alternative, surrogate endpoint. In this paper, we adapt the surrogate marker evaluation methodology of Alonso et al. (2003); (2006), developed for the case of two longitudinal outcomes, to the situation where either a longitudinal surrogate and cross sectional true endpoint is recorded, or vice versa. The work is motivated by a preclinical experiment conducted to assess association between corticosterone (CORT), heart rate, and blood pressure in rats, the data from which are then subjected to analysis. It was found that there is a weak relationship between CORT and behavior, and between CORT on the one hand and heart rate and blood pressure on the other hand, but a reasonably high degree of association was registered between heart rate and behavior.
Notes: [Tilahun, Abel; Maringwa, John T.; Alonso, Ariel; Molenberghs, Geert] Hasselt Univ, Ctr Stat, Diepenbeek, Belgium. [Geys, Helena; Raeymaekers, Leen; Kieboom, Gerd Van Den; Drinkenburg, Pim; Bijnens, Luc] Johnson & Johnson Pharmaceut Res & Dev, Beerse, Belgium.
Keywords: fractional polynomial; R² Λ ; spline; surrogate endpoint; true endpoint; variance reduction factor;Fractional polynomial; R2; Spline; Surrogate endpoint; True endpoint; Variance reduction factor
Document URI: http://hdl.handle.net/1942/9253
ISSN: 1054-3406
e-ISSN: 1520-5711
DOI: 10.1080/10543400802527924
ISI #: 000262247900013
Rights: Copyright © Taylor & Francis Group, LLC
Category: A1
Type: Journal Contribution
Validations: ecoom 2010
Appears in Collections:Research publications

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