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2. Best practice considerations for nonclinical in vivo cardiovascular telemetry studies in non-rodent species: Delivering high quality QTc data to support ICH E14/S7B Q&As

Author

Rossman, Eric I., Wisialowski, Todd A., Vargas, Hugo M., Valentin, Jean-Pierre, Rolf, Michael G., Roche, Brian M., Riley, Steve, Pugsley, Michael K., Nichols, Jill, Li, Dingzhou, Leishman, Derek J., Kleiman, Robert B., Greiter-Wilke, Andrea, Gintant, Gary A., Engwall, Michael J., Delaunois, Annie, and Authier, Simon

Published
2023
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3. The incidence of spontaneous arrhythmias in telemetered beagle dogs, Göttingen Minipigs and Cynomolgus non-human primates: A HESI consortium retrospective analysis

Author

Boulay, Emmanuel, Miraucourt, Loïs S., Pugsley, Michael K., Abernathy, Matthew M., Chui, Ray, Dalton, Jill, Demers, Marjorie, Dybdal, Noel, Gazaille, Elissa, Greiter-Wilke, Andrea, Hoffmann, Peter, Huang, Hai, LaDuke, Carrie, Norton, Kevin, Pierson, Jennifer B., Reeves, Isabelle, Roche, Brian, Rossman, Eric I., Schultze, Albert E., Tang, Hai-Ming, Wisialowski, Todd, and Authier, Simon

Published
2023
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5. General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy

Author

Li, Zhihua, Mirams, Gary R, Yoshinaga, Takashi, Ridder, Bradley J, Han, Xiaomei, Chen, Janell E, Stockbridge, Norman L, Wisialowski, Todd A, Damiano, Bruce, Severi, Stefano, Morissette, Pierre, Kowey, Peter R, Holbrook, Mark, Smith, Godfrey, Rasmusson, Randall L, Liu, Michael, Song, Zhen, Qu, Zhilin, Leishman, Derek J, Steidl‐Nichols, Jill, Rodriguez, Blanca, Bueno‐Orovio, Alfonso, Zhou, Xin, Passini, Elisa, Edwards, Andrew G, Morotti, Stefano, Ni, Haibo, Grandi, Eleonora, Clancy, Colleen E, Vandenberg, Jamie, Hill, Adam, Nakamura, Mikiko, Singer, Thomas, Polonchuk, Liudmila, Greiter‐Wilke, Andrea, Wang, Ken, Nave, Stephane, Fullerton, Aaron, Sobie, Eric A, Paci, Michelangelo, Tshinanu, Flora Musuamba, and Strauss, David G

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Arrhythmias, Cardiac, Computer Simulation, Drug-Related Side Effects and Adverse Reactions, Humans, Models, Theoretical, Risk Assessment, Validation Studies as Topic, Pharmacology & Pharmacy, Pharmacology and pharmaceutical sciences
Abstract

This white paper presents principles for validating proarrhythmia risk prediction models for regulatory use as discussed at the In Silico Breakout Session of a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/US Food and Drug Administration-sponsored Think Tank Meeting on May 22, 2018. The meeting was convened to evaluate the progress in the development of a new cardiac safety paradigm, the Comprehensive in Vitro Proarrhythmia Assay (CiPA). The opinions regarding these principles reflect the collective views of those who participated in the discussion of this topic both at and after the breakout session. Although primarily discussed in the context of in silico models, these principles describe the interface between experimental input and model-based interpretation and are intended to be general enough to be applied to other types of nonclinical models for proarrhythmia assessment. This document was developed with the intention of providing a foundation for more consistency and harmonization in developing and validating different models for proarrhythmia risk prediction using the example of the CiPA paradigm.

Published
2020

8. The Safety Pharmacology Society salary survey

Author

Pugsley, Michael K., Authier, Simon, Brabham, Tiffini, Soloviev, Maxim, Markgraf, Carrie G., Correll, Krystle, Traebert, Martin, Greiter-Wilke, Andrea, Valentin, Jean-Pierre, Vargas, Hugo, Botchway, Alfred, Leishman, Derek J., and Curtis, Michael J.

Published
2017
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18. JTp and Tpe as Biomarkers of proarrhythmic risk in nonclinical models: Historical data evaluation by the HESI consortium

Author

Gendron-Parra, Nicolas, primary, Abernathy, Matthew M., additional, Boulay, Emmanuel, additional, Chui, Ray, additional, Friedrichs, Gregory S., additional, Greiter-Wilke, Andrea, additional, Guillon, Jean-michel, additional, Leishman, Derek J., additional, Nichols, Jill, additional, Pierson, Jennifer, additional, Skinner, Matt, additional, Pugsley, Michael K., additional, Valentin, Jean-Pierre, additional, Vargas, Hugo M., additional, and Authier, Simon, additional

Published
2018
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21. An Overview of the Safety Pharmacology Society (SPS) Strategic Plan (2016-2018)

Author

Pugsley, Michael K., primary, Authier, Simon, additional, Koerner, John, additional, Redfern, Will S., additional, Markgraf, Carrie G., additional, Brabham, Tiffini, additional, Correll, Krystle, additional, Soloviev, Maxim, additional, Botchway, Alfred, additional, Engwall, Michael, additional, Traebert, Martin, additional, Valentin, Jean-Pierre, additional, Mow, Tomas, additional, Greiter-Wilke, Andrea, additional, Prior, Helen, additional, Vargas, Hugo M., additional, and Leishman, Derek J., additional

Published
2017
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28. Comparison of Telemetry and High-Definition Oscillometry for Blood Pressure Measurements in Conscious Dogs: Effects of Torcetrapib

Author

Meyer, Olivier, Jenni, Roland, Greiter-Wilke, Andrea, Breidenbach, Alexander, and Holzgrefe, Henry H

Subjects
Dogs, Behavior, Animal, Heart Rate, Oscillometry, Quinolines, Animals, Reproducibility of Results, Telemetry, Blood Pressure, Blood Pressure Determination, Experimental Use
Abstract

This study compared torcetrapib-induced blood pressure (BP) changes simultaneously obtained by high-definition oscillometry (HDO) and telemetry. Male beagles (n = 6) received single oral doses of vehicle or torcetrapib at 10 or 30 mg/kg; BP were acquired simultaneously by HDO and telemetry from 2 h before dosage until 7 h afterward. Systolic, diastolic, and mean arterial pressures (MAP) and heart rate were compared by using Altman-Bland agreement analysis. Dogs were allocated into subgroups according to temperament and baseline MAP (less than 110 mm Hg and 110 mm Hg or greater). Both methods demonstrated high precision. HDO recordings exhibited higher variability for all parameters (inclusive MAP SDs were 7.0 +/- 2.7 mm Hg for HDO compared with 3.4 +/- 1.9 mm Hg for telemetry), accompanied by a positive bias for all pressures (systolic, 10.4 mm Hg; diastolic, 5.7 mm Hg; MAP, 1.9 mm Hg). Both methods detected similar maximal increases in MAP with 30 mg/kg torcetrapib (HDO, 15.8 +/- 10.4 mm Hg; telemetry, 15.8 +/- 5.3 mm Hg). No significant effects were noted for heart rate. Torcetrapib elicited a dose-dependent increase in BP in dogs with baseline MAP of less than 110 mm Hg, whereas increases were maximal with 10 mg/kg in the other group, and dose-dependence was no longer observed. BP changes were influenced by animal temperament, demonstrating that HDO results must be interpreted with caution. HDO may provide a useful and accurate method for noninvasive BP measurements in canine studies.

Published
2010

29. How do large pharmaceutical companies mitigate concerns of drug-induced QT prolongation in drug discovery?

Author

Valentin, Jean-Pierre, primary, Baker, David, additional, Gallacher, David, additional, Gintant, Gary, additional, Greiter-Wilke, Andrea, additional, Guillon, Jean-Michel, additional, Himmel, Herbert, additional, Kasai, Chieko, additional, Leishman, Derek, additional, Levesque, Paul, additional, Louttit, James, additional, Ratcliffe, Sian, additional, Sannajust, Frederick, additional, Suter, Willi, additional, Vargas, Hugo, additional, and Yamamoto, Keiji, additional

Published
2014
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31. Quantitative analysis of inflammatory and immune responses in dogs with gastritis and their relationship to Helicobacter spp. infecton

Author

Wiinberg, Bo, Spohr, Anette, Dietz, Hans Henrik, Egelund, Thomas, Greiter-Wilke, Andrea, McDonough, Sean P., Olsen, John, Priestnall, Simon, Chang, Yung Fu, Simpson, Kenneth W., Wiinberg, Bo, Spohr, Anette, Dietz, Hans Henrik, Egelund, Thomas, Greiter-Wilke, Andrea, McDonough, Sean P., Olsen, John, Priestnall, Simon, Chang, Yung Fu, and Simpson, Kenneth W.

Published
2005

42. Association of Helicobacterwith Cholangiohepatitis in Cats

Author

Greiter‐Wilke, Andrea, Scanziani, E., Soldati, S., McDonough, S.P., McDonough, P.L., Center, S.A., Rishniw, M., and Simpson, K.W.

Abstract

Infection with Helicobacterspp. is increasingly linked with hepatobiliary inflammation and neoplasia in people and in a variety of animals. We sought to determine if Helicobacterspecies infection is associated with Cholangiohepatitis in cats. Deoxyribonucleic acid was extracted from tissue blocks from cats with Cholangiohepatitis (32), noninflammatory liver disease (13), and cats with normal liver histology (4). Deoxyribonucleic acid was polymerase chain reaction‐amplified with 2 sets of Helicobactergenus‐specific primers, gel purified, and sequenced. Polymerase chain reaction‐positive hepatic tissue was further examined with Steiner's stain, immunocytochemistry for Helicobacterspecies, and eubacterial fluorescent in situ hybridization. Gastric tissues of cats with known Helicobacterinfection status served as controls for deoxyribonucleic acid extraction and sequence comparison. Helicobacterspecies were detected in 2/32 cats with Cholangiohepatitis, and 1/17 controls. Sequences had 100% identity with Helicobacterspecies liver, Helicobacter pylori, and Helicobacter fenelliaelcinaediiin a cat with suppurative cholangitis, Helicobacterspecies liver, Helicobacter pylori, and Helicobacter nemistrineaein a cat with mild lymphocytic portal hepatitis, and Helicobacter billsin a cat with portosystemic vascular anomaly. In contrast, sequences from gastric biopsies showed highest homology (99–100%) to “Helicobacter heilmannii,” Helicobacter bizzozeronii, Helicobacter felis, and Helicobacter salomonis.Fluorescent in situ hybridization revealed a semicurved bacterium, with Helicobacter‐like morphology, in an intrahepatic bile duct of the cat with suppurative cholangitis. This study has identified Helicobacterdeoxyribonucleic acid in 2/32 cats with Cholangiohepatitis and 1/13 cats with noninflammatory liver disease. Deoxyribonucleic acid sequences of hepatic Helicobacterspecies were distinct from those found in the stomach and are broadly consistent with those identified in cat intestine and bile, and hepatobiliary disease in people and rodents.

Published
2006
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43. Quantitative Analysis of Inflammatory and Immune Responses in Dogs with Gastritis and Their Relationship to Helicobacterspp. Infection

Author

Wiinberg, Bo, Spohr, Anette, Dietz, Hans Henrik, Egelund, Thomas, Greiter‐Wilke, Andrea, McDonough, Sean P., Olsen, John, Priestnall, Simon, Chang, Yung Fu, and Simpson, Kenneth W.

Abstract

The present study sought to quantitatively examine mucosal inflammatory and immune responses in dogs with gastritis and the relationship of these responses to infection with Helicobacter.Gastric biopsies from 30 dogs were evaluated for B‐ and T‐lymphocytes, neutrophils, eosinophils, macrophages, and mast cells. Mucosal atrophy, fibrosis, cellularity, and severity of gastritis were graded qualitatively. Messenger‐RNA (mRNA) for actin, interleukin‐1β (IL‐1β), IL‐4, IL‐8, and IL‐10, transforming growth factor beta (TGF‐β), and interferon gamma (IFN‐γ) was quantified by polymerase chain reaction (PCR). The presence of Helicobacterspp. was determined by urease activity, histology, PCR, and enzyme‐linked immunosorbent assay. mRNA for IL‐1β, IL‐8, IL‐10, TGF‐β, and IFN‐γ was detected in most dogs. IL‐4 mRNA was detected in only 1 dog. Correlations were observed for IL‐1β versus IL‐8 and IL‐10; IL‐8 versus IL‐10, IFN‐γ, and TGF‐β; and IL‐10 versus IFN‐γ. Mucosal pathology was related to cytokine mRNA expression (neutrophils to IL‐8 and IFN‐γ, macrophages and lymphocytes to IFN‐γ, and fibrosis to IL‐1β). Gastritis was categorized as lymphoplasmacytic in all dogs, and its histologic severity correlated with atrophy, infiltration with lymphocytes and macrophages, and expression of IL‐10 and IFN‐γ. Of the dogs examined, 76.7% were infected with Helicobacterspp. Infection was associated with increased expression of TGF‐β and fibrosis. Circulating anti‐Helicobacterimmunoglobulin G titers were higher in uninfected than infected dogs. We conclude that lymphoplasmacytic gastritis in dogs is characterized by concurrent activation of proinflammatory and immunomodulatory cytokines, with increased mRNA expression related to mucosal pathology. No significant associations between Helicobacterinfection and proinflammatory cytokine expression, severity of gastritis, or differences in the pathogenicity of different Helicobacterspp. were found.

Published
2005
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46. JTp and Tpe as Biomarkers of proarrhythmic risk in nonclinical models: Historical data evaluation by the HESI consortium.

Author

Gendron-Parra, Nicolas, Abernathy, Matthew M., Boulay, Emmanuel, Chui, Ray, Friedrichs, Gregory S., Greiter-Wilke, Andrea, Guillon, Jean-michel, Leishman, Derek J., Nichols, Jill, Pierson, Jennifer, Skinner, Matt, Pugsley, Michael K., Valentin, Jean-Pierre, Vargas, Hugo M., and Authier, Simon

Subjects
*BIOMARKERS, *BIOLOGICAL tags, *CONSORTIA, *DATA modeling, *BEAGLE (Dog breed)
Published
2019
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47. Comparison of telemetry and high-definition oscillometry for blood pressure measurements in conscious dogs: effects of torcetrapib.

Author

Meyer O, Jenni R, Greiter-Wilke A, Breidenbach A, and Holzgrefe HH

Subjects
Animals, Behavior, Animal, Blood Pressure Determination methods, Heart Rate drug effects, Oscillometry methods, Reproducibility of Results, Telemetry methods, Blood Pressure drug effects, Blood Pressure Determination veterinary, Dogs physiology, Oscillometry veterinary, Quinolines pharmacology, Telemetry veterinary
Abstract

This study compared torcetrapib-induced blood pressure (BP) changes simultaneously obtained by high-definition oscillometry (HDO) and telemetry. Male beagles (n = 6) received single oral doses of vehicle or torcetrapib at 10 or 30 mg/kg; BP were acquired simultaneously by HDO and telemetry from 2 h before dosage until 7 h afterward. Systolic, diastolic, and mean arterial pressures (MAP) and heart rate were compared by using Altman-Bland agreement analysis. Dogs were allocated into subgroups according to temperament and baseline MAP (less than 110 mm Hg and 110 mm Hg or greater). Both methods demonstrated high precision. HDO recordings exhibited higher variability for all parameters (inclusive MAP SDs were 7.0 +/- 2.7 mm Hg for HDO compared with 3.4 +/- 1.9 mm Hg for telemetry), accompanied by a positive bias for all pressures (systolic, 10.4 mm Hg; diastolic, 5.7 mm Hg; MAP, 1.9 mm Hg). Both methods detected similar maximal increases in MAP with 30 mg/kg torcetrapib (HDO, 15.8 +/- 10.4 mm Hg; telemetry, 15.8 +/- 5.3 mm Hg). No significant effects were noted for heart rate. Torcetrapib elicited a dose-dependent increase in BP in dogs with baseline MAP of less than 110 mm Hg, whereas increases were maximal with 10 mg/kg in the other group, and dose-dependence was no longer observed. BP changes were influenced by animal temperament, demonstrating that HDO results must be interpreted with caution. HDO may provide a useful and accurate method for noninvasive BP measurements in canine studies.

Published
2010

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