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The application of electrophysiological methods to characterize AMPA receptors in dissociated adult rat and non-human primate cerebellar neurons for use in neuronal safety pharmacology assessments of the central nervous system.

Loïs S Miraucourt, Michael V Accardi, Karen E Asin, Michael K Pugsley, Michael J Curtis, Simon Authier,

INTRODUCTION:Pre-clinically, safety risk assessment of a drug is primarily tested in vivo using functional evaluation of adult animals while the mechanistic etiology of drug-induced CNS adverse effects is often uncharacterized. In vitro electrophysiology may provide a better understanding of drug effects without additional animal use. However, in vitro protocols are ... Read more >>

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2020, :106883]

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Unraveling the mechanism and the risk behind seizure liability of lead compounds in a neuroscience project.

Annie Delaunois, Michael V Accardi, Véronique André, Simon Authier, François Bouzom, Simon Hebeisen, Yves Lamberty, Faiza Laredj, Karine Leclercq, Anne-Gaëlle Letombe, Marie-Luce Rosseels, Chiara Carla Rospo, Marie-Christine Tordeur, Jean-Pierre Valentin, Martyn Wood,

INTRODUCTION:Several compounds from a neuroscience project induced convulsions in animals, at low exposure levels via a hypothetical off-target mechanism. A set of in vitro and in vivo experiments were conducted in order to 1) identify the mechanism behind convulsions; 2) characterize the convulsions, 3) detect premonitory signs that could be ... Read more >>

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2020, 104:106874]

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An Industry Survey With Focus on Cardiovascular Safety Pharmacology Study Design and Data Interpretation.

Simon Authier, Matthew M Abernathy, Krystle Correll, Ray W Chui, Jill Dalton, C Michael Foley, Gregory S Friedrichs, John E Koerner, Mary-Jeanne Kallman, Malar Pannirselvam, William S Redfern, Vijay Urmaliya, Jean-Pierre Valentin, Todd Wisialowski, Tanja S Zabka, Michael K Pugsley,

INTRODUCTION:The Safety Pharmacology Society (SPS) conducted a membership survey to examine industry practices related mainly to cardiovascular (CV) safety pharmacology (SP). METHODS:Questions addressed nonclinical study design, data analysis methods, drug-induced effects, and conventional and novel CV assays. RESULTS:The most frequent therapeutic area targeted by drugs developed by the companies/institutions that ... Read more >>

Int. J. Toxicol. (International journal of toxicology)
[2020, :1091581820921338]

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Cerebrospinal Fluid Characterization in Cynomolgus Monkeys, Beagle Dogs, and Göttingen Minipigs.

Cristina Ballesteros, Mylène Pouliot, Rémi Froment, Mohamed Said Maghezzi, Camille St-Jean, Christian Li, Dominique Paquette, Simon Authier,

Intrathecal administration is an important route for drug delivery, and in pharmacology and toxicology studies, cerebrospinal fluid (CSF) collection and analysis is required for evaluating blood-brain barrier penetration and central nervous system exposure. The characteristics of CSF in commonly used nonrodent models are lacking. The purpose of this study is ... Read more >>

Int. J. Toxicol. (International journal of toxicology)
[2020, 39(2):124-130]

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Occurrence of spontaneous arrhythmias in freely moving non-treated healthy telemetered Sprague-Dawley rats.

Paula Juliana Brizuela de Seadi Pereira, Mylene Pouliot, Alison Easter, Claudia Harper, Annick Prefontaine, Lois Miraucourt, Wendy Tan, Mohamed Said Maghezzi, Rob Wallis, Simon Authier,

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 99:106595]

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Interspecies Comparison of Control Data From Embryo-Fetal Development Studies in Sprague-Dawley Rats, New Zealand White Rabbits, and Göttingen Minipigs.

France-Helene Paradis, Anne Marie Downey, Francine Beaudry, Clémentine Pinêtre, Sisse Ellemann-Laursen, Andy Makin, Katherine Hill, Pramila Singh, Judit Hargitai, Roy Forster, Robert Tavcar, Simon Authier,

Species-dependent differences in relative incidence of spontaneous variations and malformations should be considered in the assessment of the translational value of reproductive and developmental safety assessments. The objective of this evaluation was to compare litter parameters and the frequency of external, visceral, and skeletal malformations and variations across species in ... Read more >>

Int. J. Toxicol. (International journal of toxicology)
[2019, 38(6):476-486]

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Effects of common confounders on JTp and Tpe as novel proarrhythmia biomarkers.

Emmanuel Boulay, Ariane Menard, Wendy Tan, Michelle Dubuc-Mageau, Audrey Sanfacon, Michael Pugsley, Simon Authier,

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 99:106595]

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Consensus, debates and controversies with nonclinical proarrhythmia assays.

Hai Huang, Emmanuel Boulay, Ariane Menard, Wendy Tan, Michelle Dubuc-Mageau, Audrey Sanfacon, Michael Accardi, Lois Miraucourt, Simon Authier,

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 99:106595]

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Dual effect of clonidine on QT interval duration and body temperature in cynomolgus monkeys: QT correction formula for changes in core body temperature.

Abdel-Ilah El Amrani, Hai Huang, Stephane Loriot, Francine El Amrani, Pramila Singh, Simon Authier, Roy Forster,

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 99:106595]

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Characterization of EEG morphologies during drug-induced seizures and Peri-ictal changes in non-clinical species.

Simon Authier, Mylene Pouliot, Dominique Paquette, Michelle Dubuc-Mageau, Audrey Sanfacon, Wendy Tan, Michael Accardi,

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 99:106595]

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Novel Methods for the Assessment of Safety Pharmacology and Toxicology Parameters in Anesthetized and Ventilated Dogs Receiving Inhaled Drugs.

Kim Bujold, Juergen Pfeiffer, Simon Authier, Richard Malcolmson, Jim Fink, Jeff Tepper,

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 99:106595]

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Proof of concept comprehensive ex vivo neurological assay.

Lois Miraucourt, Michael Accardi, Hai Huang, Simon Authier,

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 99:106595]

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Biochemical and Electroretinographic Characterization of the Minipig Eye in the Context of Drug Safety Investigations.

Luis Fernando Negro Silva, Christian Li, Paula Juliana Brizuela de Seadi Pereira, Wendy Tan, Michelle Dubuc-Mageau, Audrey Sanfacon, Roy Forster, Robert Tavcar, Andy Makin, Simon Authier,

Minipigs are an emerging nonrodent alternative for ocular toxicology owing to anatomical similarities in the minipig eyes when compared to humans. Ocular structures and components from Göttingen minipigs were characterized and compared to species commonly used in toxicology. Ocular reference data from Göttingen minipig including intraocular pressure, vitreous electrolyte and ... Read more >>

Int. J. Toxicol. (International journal of toxicology)
[2019, 38(5):415-422]

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Salivary Metabolomics of Total Body Irradiated Nonhuman Primates Reveals Long-Term Normal Tissue Responses to Radiation.

Evagelia C Laiakis, Denise Nishita, Kim Bujold, Meth M Jayatilake, James Bakke, Janet Gahagen, Simon Authier, Polly Chang, Albert J Fornace,

PURPOSE:To identify metabolomic biomarkers of acute radiation exposure in saliva that show time-dependent changes. METHODS AND MATERIALS:Nonhuman primates were exposed to 4 Gy of total body irradiation with γ-rays. Saliva was collected from 7 animals twice before and at days 1, 3, 5, 7, 15, 21, 28, and 60 after ... Read more >>

Int. J. Radiat. Oncol. Biol. Phys. (International journal of radiation oncology, biology, physics)
[2019, 105(4):843-851]

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Non-human primate neuropharmacology refinement: Polysomnography and regional qEEG with social housing in ETS 123 compliant cages.

Theo Dinklo, Pilar Garces, Christopher Chatham, Mylene Pouliot, Simon Authier,

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 99:106595]

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Non-clinical radiation biology and pharmacology models: appraisal of state-of-the-art and innovation.

Simon Authier, David Cassatt, Polly Chang,

Int. J. Radiat. Biol. (International journal of radiation biology)
[2020, 96(1):1-3]

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Methodological and technological advances in safety pharmacology - New or simply nuanced?

Michael K Pugsley, Tessa de Korte, Venkatesha Udupa, Simon Authier, Michael J Curtis,

This editorial previews and summarizes the content of the current themed issue of J Pharm Tox Methods derived from the recent 2018 Annual Safety Pharmacology Society (SPS) meeting held in Washington, DC. The papers highlight improvements in methods and study endpoints used in non-clinical safety pharmacology (SP) to enhance clinical ... Read more >>

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 99:106604]

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Reprint of "EEG: Characteristics of drug-induced seizures in rats, dogs and non-human primates".

Simon Authier, Joseph Arezzo, Mylène Pouliot, Michael V Accardi, Emmanuel Boulay, Eric Troncy, Michelle Dubuc Mageau, Wendy Tan, Audrey Sanfacon, Stephanie Mignault Goulet, Dominique Paquette,

Seizures are amongst the most frequent neurological issues encountered in pre-clinical safety testing. The objective was to characterize EEG morphologies and premonitory signs in drug-induced seizures in preclinical species. A comparative (inter-species) retrospective analysis for drug-induced seizures recorded by video-telemetry was conducted in rats (n = 53), dogs (n = 195), and non-human primates ... Read more >>

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 99:106611]

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Incidence of spontaneous arrhythmias in freely moving healthy untreated Sprague-Dawley rats.

Paula Juliana Seadi Pereira, Michael K Pugsley, Eric Troncy, Wendy Tan, Mylene Pouliot, Claudia Harper, Annick Prefontaine, Alison Easter, Rob Wallis, Lois Miraucourt, Hai Huang, Michael V Accardi, Emmanuel Boulay, Mohamed Said Maghezzi, Simon Authier,

Spontaneous arrhythmia characterization in healthy rats can support interpretation when studying novel therapies. Male (n = 55) and female (n = 40) Sprague-Dawley rats with telemetry transmitters for a derivation II ECG. Arrhythmias were assessed from continuous ECG monitoring over a period of 24-48 h, and data analyzed using an automated detection algorithm with 100% ... Read more >>

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 99:106589]

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Neurofunctional test batteries in safety pharmacology - Current and emerging considerations for the drug development process.

Samuel J Jackson, Simon Authier, Henning Brohmann, Susan M G Goody, David Jones, Helen Prior, Anke Rosch, Martin Traebert, Karen Tse, Jean Pierre Valentin, Aileen Milne,

Regulatory guidelines recommend specialised safety pharmacology assessments in animals to characterise drug-induced effects on the central nervous system (CNS) prior to first-in-human trials, including the functional observational battery or Irwin test (here collectively termed neurofunctional assessments). These assessments effectively detect overtly neurotoxic drugs; however, the suitability of the in vivo ... Read more >>

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 100:106602]

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Pharmacodynamics of romiplostim alone and in combination with pegfilgrastim on acute radiation-induced thrombocytopenia and neutropenia in non-human primates.

Karen Wong, Polly Y Chang, Mark Fielden, Anne Marie Downey, Deborah Bunin, James Bakke, Janet Gahagen, Lalitha Iyer, Sameer Doshi, Wieslaw Wierzbicki, Simon Authier,

Purpose: Evaluation of the pharmacodynamics (PD) and pharmacokinetics (PK) of romiplostim alone and in combination with pegfilgrastim in a non-human primate (NHP) model of acute radiation syndrome (ARS).Materials and methods: Male and female rhesus macaques were subjected to Cobalt-60 γ irradiation, at a dose of 550 cGy 24 h prior to ... Read more >>

Int. J. Radiat. Biol. (International journal of radiation biology)
[2020, 96(1):155-166]

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Temporal Effects on Radiation Responses in Nonhuman Primates: Identification of Biofluid Small Molecule Signatures by Gas Chromatography – Mass Spectrometry Metabolomics

Evan Pannkuk, Evagelia Laiakis, Michael Girgis, Sarah Dowd, Suraj Dhungana, Denise Nishita, Kim Bujold, James Bakke, Janet Gahagen, Simon Authier, Polly Chang, Albert Fornace,

Abstract Whole body exposure to ionizing radiation (IR) (> 0.7 Gy) damages tissues leading to a range of physical symptoms contributing to acute radiation syndrome (ARS). Radiation biodosimetry aims to determine characteristic early biomarkers indicative of radiation exposure (generally at doses > 2 Gy) and is a necessity for effective ... Read more >>

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EEG: Characteristics of drug-induced seizures in rats, dogs and non-human primates.

Simon Authier, Joseph Arezzo, Mylène Pouliot, Michael V Accardi, Emmanuel Boulay, Eric Troncy, Michelle Dubuc Mageau, Wendy Tan, Audrey Sanfacon, Stephanie Mignault Goulet, Dominique Paquette,

Seizures are amongst the most frequent neurological issues encountered in pre-clinical safety testing. The objective was to characterize EEG morphologies and premonitory signs in drug-induced seizures in preclinical species. A comparative (inter-species) retrospective analysis for drug-induced seizures recorded by video-telemetry was conducted in rats (n = 53), dogs (n = 195), and non-human primates ... Read more >>

J Pharmacol Toxicol Methods (Journal of pharmacological and toxicological methods)
[2019, 97:52-58]

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A Proof-of-Concept Evaluation of JTPc and Tp-Tec as Proarrhythmia Biomarkers in Preclinical Species: A Retrospective Analysis by an HESI-Sponsored Consortium.

Emmanuel Boulay, Matthew M Abernathy, Ray Chui, Gregory S Friedrichs, Nicolas Gendron-Parra, Andrea Greiter-Wilke, Jean-Michel Guillon, John E Koerner, Ariane Menard, Jill Steidl-Nichols, Jennifer Pierson, Michael K Pugsley, Eric I Rossman, David Strauss, Eric Troncy, Jean-Pierre Valentin, Todd Wisialowski, Simon Authier,

INTRODUCTION:Based on the ICH S7B and E14 guidance documents, QT interval (QTc) is used as the primary in vivo biomarker to assess the risk of drug-induced torsades de pointes (TdP). Clinical and nonclinical data suggest that drugs that prolong the corrected QTc with balanced multiple ion channel inhibition (most importantly ... Read more >>

Int. J. Toxicol. (International journal of toxicology)
[2019, 38(1):23-32]

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Pharmacokinetic study of Sudaxine in dog plasma using novel LC-MS/MS method.

Ghaith Altawallbeh, Laura Smith, Stephen J Lewis, Simon Authier, Kim Bujold, Benjamin Gaston, Ilya Bederman,

CONTEXT:Sudaxine is a novel respiratory stimulant that increases ventilatory drive via NO+ -thiolate signaling and is under development for reversal of opioid-induced respiratory depression and other critical care indications. OBJECTIVE:This study investigates the pharmacokinetic characteristics after intravenous administration of Sudaxine by using a simple liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. ... Read more >>

Drug Test Anal (Drug testing and analysis)
[2019, 11(3):403-410]

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