Left thoracotomy surgical approach for chronic instrumentation in dogs and monkeys providing high-quality electrocardiogram signals

Henriques, Tracy A.; Beck, Thomas W.; Douglas, Christopher L.; Jones, Hilton M.; Kremer, John J.; Kruzich, Paul J.; Sarazan, R. Dustan

doi:10.1016/j.vascn.2010.05.017

Cited by 18 publications

(3 citation statements)

References 17 publications

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“…These results are consistent with those from other studies with moxifloxacin in conscious dog (Henriques et al, 2010;Mittelstadt & Hart, 2005;Ollerstam et al, 2007;Sivarajah et al, 2010).…”

Section: Cardiovascular Data From the Conscious Dog Telemetry Modelsupporting

confidence: 93%

A multi-site comparison of in vivo safety pharmacology studies conducted to support ICH S7A & B regulatory submissions

Ewart

Milne

Adkins

et al. 2013

Journal of Pharmacological and Toxicological Methods

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“…These results are consistent with those from other studies with moxifloxacin in conscious dog (Henriques et al, 2010;Mittelstadt & Hart, 2005;Ollerstam et al, 2007;Sivarajah et al, 2010).…”

Section: Cardiovascular Data From the Conscious Dog Telemetry Modelsupporting

confidence: 93%

A multi-site comparison of in vivo safety pharmacology studies conducted to support ICH S7A & B regulatory submissions

Ewart

Milne

Adkins

et al. 2013

Journal of Pharmacological and Toxicological Methods

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“…The direct application of epicardial ECG electrodes to research animals has become increasingly popular. 33 Since the heart is already surgically exposed for electrode placement, the additional burden of inserting a pressure transducer (or catheter) into the left ventricle is relatively small. Modern data acquisition and analysis systems use simple algorithms that allow real-time analysis of cardiac contractility indices.…”

Section: Discussionmentioning

confidence: 99%

Cardiovascular Function in Nonclinical Drug Safety Assessment

et al. 2011

Self Cite

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There are several recent examples where clinically significant, safety-related, drug effects on hemodynamics or cardiac function were not apparent until large clinical trials were completed or the drugs entered the consumer market. Such late-stage safety issues can have significant impact on patient health and consumer confidence, as well as ramifications for the regulatory, pharmaceutical, and financial communities. This manuscript provides recommendations that evolved from a 2009 HESI workshop on the need for improved translation of nonclinical cardiovascular effects to the clinical arena. The authors conclude that expanded and improved efforts to perform sensitive yet specific evaluations of functional cardiovascular parameters in nonclinical studies will allow pharmaceutical companies to identify suspect drugs early in the discovery and development process while allowing promising drugs to proceed into clinical development.

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“…Previous publications have described telemetry transmitter 5,14,25 and VAP 15,24 implantation techniques similar to those we used. A ventral midline incision was made in the abdomen, starting at the xiphoid process extending caudally 1 to 2 cm beyond the umbilicus, and the abdomen accessed.…”

Section: Methodsmentioning

confidence: 99%

Automated Blood Sampling in a Canine Telemetry Cardiovascular Model

et al. 2021

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Successful implementation of automated blood sampling (ABS) into a telemetry instrumented canine cardiovascular model provides simultaneous cardiovascular assessment of novel compounds while collecting multiple blood samples for analysis of drug level, cytokines, and biomarkers. Purpose-bred male Beagle dogs (n = 36) were instrumented with a dual-pressure telemetry transmitter and vascular access port. Modifications to acclimation practices, surgical procedures, and housing were required for implementation of ABS in our established cardiovascular canine telemetry colony. These modifications have increased the use and reproducibility of the model by combining early pharmacokinetic and cardiovascular studies, thus achieving both refinement and reduction from a 3R perspective. In addition, the modified model can shorten timelines and reduce the compound requirement in early stages of drug development. This telemetry–ABS model provides an efficient means to quickly identify potential effects on key cardiovascular parameters in a large animal species and to obtain a more complete pharmacokinetic–pharmacodynamic profile for discovery compounds.

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Left thoracotomy surgical approach for chronic instrumentation in dogs and monkeys providing high-quality electrocardiogram signals

Cited by 18 publications

References 17 publications

A multi-site comparison of in vivo safety pharmacology studies conducted to support ICH S7A & B regulatory submissions

A multi-site comparison of in vivo safety pharmacology studies conducted to support ICH S7A & B regulatory submissions

Cardiovascular Function in Nonclinical Drug Safety Assessment

Automated Blood Sampling in a Canine Telemetry Cardiovascular Model

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