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Journal of Pharmacological and Toxicological Methods

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https://www.readbyqxmd.com/read/28428100/an-overview-of-the-safety-pharmacology-career-of-dr-c-r-hassler
#1
M A Hawk, M K Pugsley, T Vinci, J Wallery, C R Hassler, R L Hamlin
Each year the Safety Pharmacology Society (SPS) recognizes an investigator who has had a marked impact upon the discipline. The 2016 recipient of the SPS Distinguished Service Award (DSA) was Dr. Craig R. Hassler. Dr. Hassler is one of the founding members of the SPS and has been actively engaged in physiological research for over 46years. Dr. Hassler delivered a talk entitled "My 43Years at Battelle Memorial Institute" to meeting attendees. In this article an overview is provided of the illustrious career of Dr...
April 17, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28416413/evaluation-of-the-physiotel%C3%A2-digital-m11-cardiovascular-telemetry-implant-in-socially-housed-cynomolgus-monkeys-up-to-16weeks-after-surgery
#2
Ninette K Andersen, Olivier Meyer, Alys Bradley, Nils Dragsted, Anders B Lassen, Ingrid Sjögren, Julie M Larsen, Warren Harvey, Rastislav Bator, Aileen Milne
INTRODUCTION: The novel PhysioTel™ Digital M11 telemetry implant was evaluated in socially housed monkeys with respect to both safety pharmacological cardiovascular (arterial blood pressure (BP), heart rate (HR) and electrocardiogram (ECG)) and toxicological (clinical pathology and histopathology) endpoints. METHODS: Telemetry and clinical pathology data were obtained repeatedly up to 16weeks after surgery in four female cynomolgus monkeys, followed by necropsy...
April 14, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28412329/comparison-of-pro-amnesic-efficacy-of-scopolamine-biperiden-and-phencyclidine-by-using-passive-avoidance-task-in-cd-1-mice
#3
Natalia Malikowska, Kinga Sałat, Adrian Podkowa
INTRODUCTION: Memory disorders accompany numerous diseases and therapies, and this is becoming a growing medical issue worldwide. Currently, various animal models of memory impairments are available; however, many of them require high financial outlay and/or are time-consuming. A simple way to achieve an efficient behavioral model of cognitive disorders is to inject defined drug that has pro-amnesic properties. Since the involvement of cholinergic and glutamatergic neurotransmission in cognition is well established, the utilization of a nonselective muscarinic receptor antagonist, scopolamine (SCOP), a selective M1 muscarinic receptor antagonist, biperiden (BIP), and a non-competitive N-methyl-d-aspartate (NMDA) receptor antagonist, phencyclidine (PCP) seems to be reliable tools to induce amnesia...
April 13, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28412328/budded-baculovirus-particles-as-a-source-of-membrane-proteins-for-radioligand-binding-assay-the-case-of-dopamine-d1-receptor
#4
Anni Allikalt, Ago Rinken
INTRODUCTION: G-protein-coupled receptors have become very important drug targets and therefore ligand binding assays for these receptors are an essential part of drug discovery. Among a variety of experimental systems, the radioligand binding assay has remained as one of the main methods in this field for decades. Usually cell membranes or tissues are used in these experiments, however in this article we demonstrate that baculoviruses produced in Sf9 cells display recombinant receptors on their surface and therefore can be used in radioligand binding assay...
April 12, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28408211/cardiac-voltage-gated-ion-channels-in-safety-pharmacology-review-of-the-landscape-leading-to-the-cipa-initiative
#5
REVIEW
Hai Huang, Michael K Pugsley, Bernard Fermini, Michael J Curtis, John Koerner, Michael Accardi, Simon Authier
Voltage gated ion channels are central in defining the fundamental properties of the ventricular cardiac action potential (AP), and are also involved in the development of drug-induced arrhythmias. Many drugs can inhibit cardiac ion currents, including the Na(+) current (INa), L-type Ca(2+) current (Ica-L), and K(+) currents (Ito, IK1, IKs, and IKr), and thereby affect AP properties in a manner that can trigger or sustain cardiac arrhythmias. Since publication of ICH E14 and S7B over a decade ago, there has been a focus on drug effects on QT prolongation clinically, and on the rapidly activating delayed rectifier current (IKr), nonclinically, for evaluation of proarrhythmic risk...
April 10, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28395991/simultaneous-determination-of-cocaine-crack-and-its-metabolites-in-oral-fluid-urine-and-plasma-by-liquid-chromatography-mass-spectrometry-and-its-application-in-drug-users
#6
Taís Regina Fiorentin, Felipe Bianchini D'Avila, Eloisa Comiran, Amanda Zamboni, Juliana Nichterwitz Scherer, Flavio Pechansky, Paulo Eduardo Mayorga Borges, Pedro Eduardo Fröehlich, Renata Pereira Limberger
INTRODUCTION: A single LC-MS equipment was used to validate three methods for simultaneously analyzing cocaine (COC), benzoylecgonine (BZE), cocaethylene (CE), anhydroecgonine methyl ester (AEME) and anhydroecgonine (AEC) in oral fluid (OF), urine and plasma. METHODS: The methods were carried out using a Kinetex HILIC column for polar compounds at 30°C. Mobile phase with isocratic condition of acetonitrile: 13mM ammonium acetate pH 6.0: methanol (55:35:10 v/v/v) at 0...
April 7, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28392242/development-of-microdialysis-methodology-for-interstitial-insulin-measurement-in-rodents
#7
Ann E Griffin, Ruth Macdonald, Anton J M Wagenmakers, Janice M Marshall, Simon M Poucher
INTRODUCTION: Accurate assessment of muscle insulin sensitivity requires measurement of insulin concentration in interstitial fluid (ISF), but has proved difficult. We aimed to optimise measurement of ISF insulin concentrations in rat muscles in vivo using microdialysis. METHODS: Factorial experimental design experiments were performed in vitro to determine optimal conditions for insulin recovery with microdialysis probes. These conditions were tested in vivo, adjusted appropriately and used in lean and obese Zucker rats to compare ISF insulin concentrations basally and during hyperinsulinaemic-euglycaemic (HE) clamp...
April 6, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28377112/the-assessment-of-electrophysiological-activity-in-human-induced-pluripotent-stem-cell-derived-cardiomyocytes-exposed-to-dimethyl-sulfoxide-and-ethanol-by-manual-patch-clamp-and-multi-electrode-array-system
#8
Soo-Wang Hyun, Bo-Ram Kim, Sung-Ae Hyun, Joung-Wook Seo
INTRODUCTION: Recently, electrophysiological activity has been effectively measured in human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) to predict drug-induced arrhythmia. Dimethyl sulfoxide (DMSO) and ethanol have been used as diluting agents in many experiments. However, the maximum DMSO and ethanol concentrations that can be effectively used in the measurement of electrophysiological parameters in hiPSC-CMs-based patch clamp and multi-electrode array (MEA) have not been fully elucidated...
April 1, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28315739/method-of-data-interpretation-for-the-determination-of-abuse-liability-in-rodent-self-administration-studies-under-the-fda-guidance-document
#9
David V Gauvin, Zachary J Zimmermann, Theodore J Baird
All new molecular entities that enter the CNS and exert an activity in the brain must be assessed for abuse liability prior to a New Drug Application approval by the US Food and Drug Administration. One element of the screening process is the assessment of the reinforcing properties of the drug candidate using the regulatory-preferred species, the rat. We describe one method of data review from the standard rat IV SA study design that can be used to conclude the relative abuse liability of the new drug entity...
March 15, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28274871/an-improved-high-efficiency-assay-for-assessing-serum-anticholinergic-activity-using-cultured-cells-stably-expressing-m1-receptors
#10
José N Nobrega, Roger J Raymond, Bruce G Pollock
Assessments of total anticholinergic activity (SAA) in serum are of considerable interest for its potential involvement in cognitive impairment associated with polydrug states in the elderly and other populations. Such estimations have been based on the displacement of radioligand binding in rat brain tissues. The validity of such measurements has been questioned, as a potentially distorting effect of large serum proteins was identified. We sought to develop a modified assay that would be more efficient and free of this potential confound...
March 6, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28259823/evaluation-of-permeability-alteration-and-epithelial-mesenchymal-transition-induced-by-transforming-growth-factor-%C3%AE-1-in-a549-nci-h441-and-calu-3-cells-development-of-an-in-vitro-model-of-respiratory-epithelial-cells-in-idiopathic-pulmonary-fibrosis
#11
Kohei Togami, Kotaro Yamaguchi, Sumio Chono, Hitoshi Tada
INTRODUCTION: Idiopathic pulmonary fibrosis (IPF) is a lethal lung disease, which is accompanied by changes in lung structure. With regard to treatment, aerosolized drugs administered intrapulmonarily are rapidly distributed into the plasma and do not remain in the lungs due to damage to the alveolar epithelium that occurs from pulmonary fibrosis. In this study, we sought to develop an in vitro model of respiratory epithelial cells in IPF for the evaluation of the intrapulmonary distribution of aerosolized drugs...
March 1, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28254506/ion-currents-of-cardiomyocytes-in-different-regions-of-the-g%C3%A3-ttingen-minipig-heart
#12
Per Arlock, Tomas Mow, Trygve Sjöberg, Anders Arner, Stig Steen, Morten Laursen
INTRODUCTION: The Göttingen minipig is a promising model for pharmacological safety assessment and for translational research in cardiology. We have examined the main ion currents in cardiomyocytes of the minipig heart. METHODS: Cardiac cells were isolated from different cardiac regions (endo-, mid- and epicardial left ventricle and right ventricle) from Göttingen minipigs and examined using the whole cell patch clamp technique combined with pharmacological interventions...
February 22, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28223123/proarrhythmia-liability-assessment-and-the-comprehensive-in-vitro-proarrhythmia-assay-cipa-an-industry-survey-on-current-practice
#13
Simon Authier, Michael K Pugsley, John E Koerner, Bernard Fermini, William S Redfern, Jean-Pierre Valentin, Hugo M Vargas, Derek J Leishman, Krystle Correll, Michael J Curtis
INTRODUCTION: The Safety Pharmacology Society (SPS) has conducted a survey of its membership to identify industry practices related to testing considered in the Comprehensive In vitro Proarrhythmia Assay (CiPA). METHODS: Survey topics included nonclinical approaches to address proarrhythmia issues, conduct of in silico studies, in vitro ion channel testing methods used, drugs used as positive controls during the conduct of cardiac ion channel studies, types of arrhythmias observed in non-clinical studies and use of the anticipated CiPA ion channel assay...
February 20, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28216264/potential-functional-and-pathological-side-effects-related-to-off-target-pharmacological-activity
#14
James J Lynch, Terry R Van Vleet, Scott W Mittelstadt, Eric A G Blomme
Most pharmaceutical companies test their discovery-stage proprietary molecules in a battery of in vitro pharmacology assays to try to determine off-target interactions. During all phases of drug discovery and development, various questions arise regarding potential side effects associated with such off-target pharmacological activity. Here we present a scientific literature curation effort undertaken to determine and summarize the most likely functional and pathological outcomes associated with interactions at 70 receptors, enzymes, ion channels and transporters with established links to adverse effects...
February 16, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28213294/a-low-cost-simplified-and-scaleable-pneumotachograph-and-face-mask-for-neonatal-mouse-respiratory-measurements
#15
Jenny J Sun, Roshan Nanu, Russell S Ray
INTRODUCTION: Neonatal respiratory disorders are a leading cause of perinatal mortality due to complications resulting from premature births and prenatal exposure to drugs of abuse, but optimal treatments for these symptoms are still unclear due to a variety of confounds and risk factors. Mouse models present an opportunity to study the underlying mechanisms and efficacy of potential treatments of these conditions with controlled variables. However, measuring respiration in newborn mice is difficult and commercial components are expensive and often require modification, creating a barrier and limiting our understanding of the short and long-term effects of birth complications on respiratory function...
February 15, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28216425/repeated-day-1-fob-testing-in-ich-s7a-safety-assessment-protocols-the-influence-of-within-and-between-session-learning
#16
REVIEW
David V Gauvin, Zachary J Zimmermann, Jill A Dalton, Theodore J Baird
A large number of CNS safety assessment studies using the standard Functional Observational Battery (FOB) are conducted each year at Contract Research Organizations throughout the globe. Study design characteristics are as varied as the Sponsors for whom they are contracted. Gender inclusion, sample sizes, and timing of the FOBs are generally negotiated during protocol development. The ICH S7A guidelines describe a dose-effect study design for CNS safety assessment to be conducted prior to the first dose administration in man...
February 12, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28192184/glp-in-safety-pharmacology-studies-report-card-after-15years
#17
Brian D Guth, Michael K Pugsley
No abstract text is available yet for this article.
February 10, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28192183/measuring-kinetics-and-potency-of-herg-block-for-cipa
#18
Monique J Windley, Najah Abi-Gerges, Bernard Fermini, Jules C Hancox, Jamie I Vandenberg, Adam P Hill
INTRODUCTION: The Comprehensive in vitro Proarrhythmic Assay (CiPA) aims to update current cardiac safety testing to better evaluate arrhythmic risk. A central theme of CiPA is the use of in silico approaches to risk prediction incorporating models of drug binding to hERG. To parameterize these models, accurate in vitro measurement of potency and kinetics of block is required. The Ion Channel Working Group was tasked with: i) selecting a protocol that could measure kinetics of block and was easily implementable on automated platforms for future rollout in industry and ii) acquiring a reference dataset using the standardized protocol...
February 10, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28167229/population-pharmacokinetics-model-of-thc-used-by-pulmonary-route-in-occasional-cannabis-smokers
#19
A Marsot, C Audebert, L Attolini, B Lacarelle, J Micallef, O Blin
Cannabis is the most widely used illegal drug in the world. Delta-9-tetrahydrocannabinol (THC) is the main source of the pharmacological effect. Some studies have been carried out and showed significant variability in the described models as the values of the estimated pharmacokinetic parameters. The objective of this study was to develop a population pharmacokinetic model for THC in occasional cannabis smokers. Twelve male volunteers (age: 20-28years, body weight: 62.5-91.0kg), tobacco (3-8 cigarette per day) and cannabis occasional smokers were recruited from the local community...
February 4, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28167230/adaptation-to-a-blood-pressure-telemetry-system-revealed-by-measures-of-activity-agility-and-operant-learning-in-mice
#20
Anfisa Popova, Darya Tsvirkun, Oleg Dolgov, Konstantin Anokhin, Jeffrey Alberts, Evgeniia Lagereva, Marc-Antoine Custaud, Guillemette Gauquelin-Koch, Olga Vinogradova, Alexander Andreev-Andrievskiy
INTRODUCTION: Implantable telemetry enables continuous monitoring of physiological functions in freely moving animals and can greatly complement pharmacological research. Despite its miniaturization, a sensor/transmitter constitutes 5% or more of a mouse's bodyweight. The aim of the present study was to evaluate whether factors related to the presence of a probe/transmitter influence the ambulatory activity, strength, agility, or operant, motivated behaviors of this small rodent. METHODS: Adult male mice (C57BL/6N, 22-25g, 9-10weeks; implanted n=26, intact n=45) were evaluated during week-long tests, conducted three and eight weeks after surgical implantation of the PA-C10 blood pressure probe...
February 3, 2017: Journal of Pharmacological and Toxicological Methods
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