Concurrent Cardiovascular and Respiratory Evaluation in Conscious Cynomolgus Monkeys

Soloviev, Maxim; Derchak, Alex; Setser, John; Steinbacher, Elizabeth A.; Klemm, J; Gumpf, Dave S.; Shellhammer, Laurie J.; Kearney, Ken; Wilson, Richard L.

doi:10.1016/j.vascn.2007.02.061

Cited by 3 publications

(4 citation statements)

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“…In recent years, jacketed, noninvasive, ambulatory telemetry systems have become commercially available for use in dogs and primates Prior et al 2009a;Ward et al 2012;Soloviev et al 2007). These enable continuous recordings of lead II ECG from surface electrodes for at least 24 h in undisturbed, freely moving animals in their home environment, when awake or asleep.…”

Section: Ecg Intervals and Morphologymentioning

confidence: 99%

“…For early toxicology studies (e.g. This noninvasive telemetry technique also enables simultaneous measurement of cardiovascular parameters ) and can also be adapted to nonhuman primates (Soloviev et al 2007;Kearney et al 2011) making it an attractive proposition for inclusion in repeat-dose toxicity studies. For this, rats are placed in the chambers for 1 h, with the first 45 min as habituation and the final 15 min for recordings, timed to be around the T max (Redfern et al 2011b).…”

Section: Respiratory Systemmentioning

confidence: 99%

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Principles of Safety Pharmacology

2015

Handbook of Experimental Pharmacology

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Section: Ecg Intervals and Morphologymentioning

confidence: 99%

Section: Respiratory Systemmentioning

confidence: 99%

Principles of Safety Pharmacology

2015

Handbook of Experimental Pharmacology

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“…170 In recent years, jacketed, noninvasive, ambulatory telemetry systems have become commercially available for use in dogs and primates. [85][86][87][88] These enable continuous recordings of lead II ECG from surface electrodes for at least 24 hours in undisturbed, freely-moving animals in their home environment, when awake or asleep. The same requirements for access to cardiovascular expertise apply as for conventional ECG recordings.…”

Section: Core Temperature Intraperitoneal Telemetry Implantmentioning

confidence: 99%

“…This technique is known as respiratory inductive plethysmography 203 and involves the placement of flexible belts around the thorax and abdomen, enabling continuous measurement of respiratory parameters for up to 24 hours. 123 This noninvasive telemetry technique also enables simultaneous measurement of cardiovascular parameters 97 and can also be adapted to non-human primates, 87,124 making it an attractive proposition for inclusion in repeat-dose toxicity studies.…”

Section: C Respiratory Systemmentioning

confidence: 99%

Functional assessments in repeat-dose toxicity studies: the art of the possible

et al. 2013

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Clinical and nonclinical safety liabilities remain a major cause of adverse drug reactions, candidate drug attrition, delays during development, labelling restrictions, non-approval, and product withdrawal. Many of the toxicities are functional in nature and/or in origin. Whereas pharmacological responses tend to be fairly rapid in onset, and are therefore detectable after a single dose, some diminish on repeated dosing, whereas others increase in magnitude and therefore can be missed or underestimated in single-dose safety pharmacology studies. Functional measurements can be incorporated into repeat-dose toxicity studies, either routinely or on an ad hoc basis. Drivers for this are both scientific (see above), and regulatory (e.g., ICH S6, S7, S9). There are inherent challenges in achieving this: the availability of suitable technical and scientific expertise in the test facility; unsuitable laboratory conditions; use of simultaneous (as opposed to staggered) dosing; requirement for toxicokinetic sampling; unsuitability of certain techniques (e.g., use of anaesthesia; surgical implantation; food restriction); equipment availability at close proximity; sensitivity of the methods to detect small, clinically relevant, changes. Nonetheless, 'fit-for-purpose' data can still be acquired without requiring additional animals. Examples include assessment of behaviour, sensorimotor, visual, and autonomic functions, ambulatory ECG and blood pressure, echocardiography, respiratory, gastrointestinal, renal and hepatic functions. This is entirely achievable if functional measurements are relatively unobtrusive, both with respect to the animals and to the toxicology study itself.Careful pharmacological validation of any methods used, and establishing their detection sensitivity, is vital to ensure the credibility of generated data.

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Inclusion of Safety Pharmacology Endpoints in Repeat-Dose Toxicity Studies

Redfern

2015

Handbook of Experimental Pharmacology

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Whereas pharmacological responses tend to be fairly rapid in onset and are therefore detectable after a single dose, some diminish on repeated dosing, and others increase in magnitude and therefore can be missed or underestimated in single-dose safety pharmacology studies. Safety pharmacology measurements can be incorporated into repeat-dose toxicity studies, either routinely or on an ad hoc basis. Drivers for this are both scientific (see above) and regulatory (e.g. ICH S6, S7, S9). There are inherent challenges in achieving this: the availability of suitable technical and scientific expertise in the test facility, unsuitable laboratory conditions, use of simultaneous (as opposed to staggered) dosing, requirement for toxicokinetic sampling, unsuitability of certain techniques (e.g. use of anaesthesia, surgical implantation, food restriction), equipment availability at close proximity and sensitivity of the methods to detect small, clinically relevant, changes. Nonetheless, 'fit-for-purpose' data can still be acquired without requiring additional animals. Examples include assessment of behaviour, sensorimotor, visual and autonomic functions, ambulatory ECG and blood pressure, echocardiography, respiratory, gastrointestinal, renal and hepatic function. This is entirely achievable if the safety pharmacology measurements are relatively unobtrusive, both with respect to the animals and to the toxicology study itself. Careful pharmacological validation of any methods used, and establishing their detection sensitivity, is vital to ensure the credibility of generated data.

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Concurrent Cardiovascular and Respiratory Evaluation in Conscious Cynomolgus Monkeys

Cited by 3 publications

References 0 publications

Principles of Safety Pharmacology

Principles of Safety Pharmacology

Functional assessments in repeat-dose toxicity studies: the art of the possible

Inclusion of Safety Pharmacology Endpoints in Repeat-Dose Toxicity Studies

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