Search Results - "Lengel, David"

Characterization of ascending dose canine telemetry model supports its use in E14/S7B QT integrated risk assessments by Chaves, Alysia A., Ferraro, Jude W., Yu, Jing, Moye, Matthew J., Yee, Ka Lai, Li, Fangbiao, Steve, Desiree L., Lengel, David J., Regan, Christopher P.

“…Nonclinical evaluation of the cardiovascular effects of novel chemical or biological entities (NCE, NBEs) is crucial for supporting first-in-human clinical…”
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An integrative pharmacological approach to radio telemetry and blood sampling in pharmaceutical drug discovery and safety assessment by Litwin, Dennis C, Lengel, David J, Kamendi, Harriet W, Bialecki, Russell A

“…A successful integration of the automated blood sampling (ABS) and telemetry (ABST) system is described. The new ABST system facilitates concomitant collection…”
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A multi-site comparison of in vivo safety pharmacology studies conducted to support ICH S7A & B regulatory submissions by Ewart, Lorna, Milne, Aileen, Adkins, Debbie, Benjamin, Amanda, Bialecki, Russell, Chen, Yafei, Ericsson, Ann-Christin, Gardner, Stacey, Grant, Claire, Lengel, David, Lindgren, Silvana, Lowing, Sarah, Marks, Louise, Moors, Jackie, Oldman, Karen, Pietras, Mark, Prior, Helen, Punton, James, Redfern, Will S., Salmond, Ross, Skinner, Matt, Some, Margareta, Stanton, Andrea, Swedberg, Michael, Finch, John, Valentin, Jean-Pierre

“…Introduction: Parts A and B of the ICH S7 guidelines on safety pharmacology describe the in vivo studies that must be conducted prior to first time in man…”
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Multi-compartmental PK-PD modeling of baclofen by Kamendi, Harriet W., Bui, Khanh, Lengel, David J., Bialecki, Russell

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Combining radio telemetry and automated blood sampling: A novel approach for integrative pharmacology and toxicology studies by Kamendi, Harriet W., Brott, David A., Chen, Yafei, Litwin, Dennis C., Lengel, David J., Fonck, Carlos, Bui, Khanh H., Gorko, Mary Ann, Bialecki, Russell A.

“…A novel automated blood sampling and telemetry (ABST) system was developed to integrate pharmacokinetic (PK), pharmacodynamic (PD) and toxicology studies. The…”
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Pharmacological characterization of ZD6021: a novel, orally active antagonist of the tachykinin receptors by Rumsey, W L, Aharony, D, Bialecki, R A, Abbott, B M, Barthlow, H G, Caccese, R, Ghanekar, S, Lengel, D, McCarthy, M, Wenrich, B, Undem, B, Ohnmacht, C, Shenvi, A, Albert, J S, Brown, F, Bernstein, P R, Russell, K

“…The tachykinins, substance P, neurokinin A, and neurokinin B, have been implicated in many diseases. The present study evaluated the pharmacological properties…”
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The combination of DSI rat telemetry and the Culex Automated Blood Sampler (ABS) for multiparameter safety pharmacology screening by Lengel, David

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Quantitative pharmacokinetic–pharmacodynamic modelling of baclofen‐mediated cardiovascular effects using BP and heart rate in rats by Kamendi, Harriet, Barthlow, Herbert, Lengel, David, Beaudoin, Marie‐Eve, Snow, Debra, Mettetal, Jerome T, Bialecki, Russell A

“…Background and Purpose While the molecular pathways of baclofen toxicity are understood, the relationships between baclofen‐mediated perturbation of individual…”
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Comparison of neurobehavioral assessment outcomes between cynomolgus macaque and human using six reference drugs by Chen, Yafei, Liu, Yongzhen, Lengel, David, Barthlow, Herbert, Bialecki, Russell

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Assessment of cisplatin-induced kidney injury using an integrated rodent platform by Chen, Yafei, Brott, David, Luo, Wenli, Gangl, Eric, Kamendi, Harriet, Barthlow, Herbert, Lengel, David, Fikes, James, Kinter, Lewis, Valentin, Jean-Pierre, Bialecki, Russell

“…Current diagnosis of drug-induced kidney injury (DIKI) primarily relies on detection of elevated plasma creatinine (Cr) or blood urea nitrogen (BUN) levels;…”
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Quantitative PKPD modeling of baclofen-mediated cardiovascular effects using blood pressure and heart rate by Bialecki, Russell, Kamendi, Harriet, Barthlow, Herbert, Lengel, David, Beaudoin, Marie-Eve, Mettetal, Jay

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Are GPR81 agonists associated with cardiovascular effects? by Benjamin, Amanda, Collins, Teresa, Fjellström, Ola, Lengel, David, Thalén, Pia, Wahlund, Göran, Wallenius, Kristina, Eriksson, Annika Westin

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Preclinical exploration of the potential antiinflammatory properties of the peptide leukotriene antagonist ICI 204,219 (Accolate) by Krell, R D, Dehaas, C J, Lengel, D J, Kusner, E J, Williams, J C, Buckner, C K

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How concordant is rodent whole body plethysmography to man? by Ewart, Lorna C., Bialecki, Russell, Ericson, Ann-Christin, Haley, Michael, Lengel, David, Prior, Helen, Scatchard, Jon, Some, Margareta, Tait, Andrea, Wallis, Rob, Valentin, Jean-Pierre

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VALIDATION OF A GUINEA PIG MODEL OF CARDIAC MONOPHASIC ACTION POTENTIAL AGAINST OTHER PRECLINICAL PREDICTORS OF QT INTERVAL PROLONGATION by Bialecki, Russell A., Duker, Gören, Ollerstam, Anna, Forsström, Elin, Ericson, Ann-Christin, Al-Saffar, Ahmad, Kågström, Jens, Löfberg, Lena, Barthlow, Herbert, Pietras, Mark, Caccese, Robert, Lengel, David, Stevenson, Jennifer, McMahon, Nick, Philp, Karen, Moors, Jackie, Pollard, Chris, Small, Ben, Bridgland-Taylor, Mathew, Valentin, Jean-Pierre

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Tachykinin-induced dyspnea in conscious guinea pigs by Kusner, E J, Buckner, C K, DeHaas, C J, Lengel, D J, Marks, R L, Krell, R D

“…Aerosol administration of neurokinin A (NKA) or substance P (SP) to conscious guinea pigs produced labored abdominal breathing (dyspnea). Time to onset of…”
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