Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
2005-01-25
2005-01-25
Bockelman, Mark (Department: 3762)
Surgery
Diagnostic testing
Cardiovascular
C600S509000
Reexamination Certificate
active
06847840
ABSTRACT:
A system and method for statistically analyzing QT interval as a function of changes in the RR interval. The system and method utilize three statistical comparisons to fully characterize the QT response: (1) the comparison of curves to give an overall effect; (2) the incidence of points exceeding a baseline upper 95% single-point prediction bound to reflect the degree of heterogeneity of ventricular repolarization; and (3) the magnitude of these points to provide a quantitative assessment of treatment-induced changes in the QT-RR relationship. The system and method use the relationship between the QT interval and heart rate (RR interval) to reference a control baseline response. Data from mammals such as humans and dogs, and pharmacological maneuvers using both cardiac and non-cardiac therapeutic agents, may be used with this multi-parameter statistical system and method. Additionally, the system and method quantifies the incidence and magnitude of points lying outside the upper 95% single-point prediction limit of the regression analysis for vehicle versus treatment.
REFERENCES:
patent: 5306293 (1994-04-01), Zacouto
patent: 6238350 (2001-05-01), Neilson
D. Raunig, et al.Statistical analysis of QT interval as a function of changes in RR interval in the conscious dog, Journal of Pharmacological and Toxicological Methods 46 (2001) 1-11.
DePasquale Michael J.
Fossa Anthony A.
Raunig David L.
Ashbrook Charles
Bockelman Mark
Engelmann John H.
Pfizer Inc.
Richardson Peter C.
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