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Journal of Pharmacological and Toxicological Methods

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https://www.readbyqxmd.com/read/28522142/integration-and-validation-of-the-ex-vivo-human-placenta-perfusion-model
#1
Sigrid Conings, Frédéric Amant, Pieter Annaert, Kristel Van Calsteren
INTRODUCTION: The ex vivo human placenta perfusion model is an effective and non-invasive method to study transplacental passage of drugs and environmental compounds in humans. Due to many challenges and its high complexity it remains difficult to incorporate it routinely into laboratories. METHODS: This article describes a step-by-step protocol for the implementation and validation of a closed-closed ex vivo perfusion model. Antipyrine, a small molecule that passes the placental barrier by passive diffusion, was used as a measurement of overlap between foetal and maternal circulation...
May 15, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28501647/application-of-optical-action-potentials-in-human-induced-pluripotent-stem-cells-derived-cardiomyocytes-to-predict-drug-induced-cardiac-arrhythmias
#2
H R Lu, M P Hortigon-Vinagre, V Zamora, I Kopljar, A De Bondt, D J Gallacher, G Smith
INTRODUCTION: Human induced pluripotent stem cell-derived cardiomyocytes (hiPS-CMs) are emerging as new and human-relevant source in vitro model for cardiac safety assessment that allow us to investigate a set of 20 reference drugs for predicting cardiac arrhythmogenic liability using optical action potential (oAP) assay. METHODS: Here, we describe our examination of the oAP measurement using a voltage sensitive dye (Di-4-ANEPPS) to predict adverse compound effects using hiPS-CMs and 20 cardioactive reference compounds...
May 10, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28476566/qsar-model-for-blood-brain-barrier-permeation
#3
Andrey A Toropov, Alla P Toropova, Marten Beeg, Marco Gobbi, Mario Salmona
BACKGROUND AND OBJECTIVE: Predicting blood-brain barrier permeability for novel compounds is an important goal for neurotherapeutics-focused drug discovery. It is impossible to determine experimentally the blood-brain barrier partitioning of all possible candidates. Consequently, alternative evaluation methods based on computational models are desirable or even necessary. The CORAL software (http://www.insilico.eu/coral) has been checked up as a tool to build up quantitative structure - activity relationships for blood-brain barrier permeation...
May 2, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28476565/a-simple-short-term-method-to-study-thyroid-disruption-using-a-fetal-rat-thyroid-culture
#4
Pablo Olivares-Trigo, Camilo Fuentes Peña, María Fernanda Cavieres
INTRODUCTION: Thyroid modulation activity has not been investigated for many chemical substances. Due to ethical, practical and financial reasons, in vivo evaluation of a large number of compounds is not feasible. It has been proposed that an in vitro mechanism-based strategy could be more adequate for the identification of thyroid hormone disrupting chemicals. Here we describe a simple and mostly inexpensive, short term culture assay to study thyroid disruption. METHODS: Fetal thyroids collected from gestation day 20...
May 2, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28465161/assessment-of-elisa-as-endpoint-in-neuronal-cell-based-assay-for-bont-detection-using-hipsc-derived-neurons
#5
Sabine Pellett, William H Tepp, Eric A Johnson, Dorothea Sesardic
INTRODUCTION: Botulinum neurotoxins (BoNTs), the causative agents of botulism, are widely used as powerful bio-pharmaceuticals to treat neuro-muscular disorders. Due to the high potency and potential lethality of BoNTs, careful monitoring of the biologic activity of BoNT-based pharmaceuticals is required to ensure safe usage. For decades, the only approved method for potency determination of pharmaceutical BoNTs was the mouse bioassay (MBA), but in recent years improvements in cell-assay technologies have enabled MBA replacement by cell-based assays for specific product evaluations...
April 29, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28461240/safety-pharmacology-methods-and-models-in-an-evolving-regulatory-environment
#6
EDITORIAL
Michael K Pugsley, Tessa de Korte, Simon Authier, Hai Huang, Michael V Accardi, Michael J Curtis
This editorial prefaces the annual themed issue on safety pharmacology (SP) methods published in the Journal of Pharmacological and Toxicological Methods (JPTM). We highlight here the content derived from the recent 2016 Safety Pharmacology Society (SPS), Canadian Society of Pharmacology and Therapeutics (CSPT), and Japanese Safety Pharmacology Society (JSPS) joint meeting held in Vancouver, B.C., Canada. This issue of JPTM continues the tradition of providing a publication summary of articles primarily presented at the joint meeting with direct bearing on the discipline of SP...
April 28, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28456609/computational-modeling-for-cardiac-safety-pharmacology-analysis-contribution-of-fibroblasts
#7
Xin Gao, Tylor Engel, Brian E Carlson, Tetsuro Wakatsuki
INTRODUCTION: Drug-induced proarrhythmic potential is an important regulatory criterion in safety pharmacology. The application of in silico approaches to predict proarrhythmic potential of new compounds is under consideration as part of future guidelines. Current approaches simulate electrophysiology of a single human adult ventricular cardiomyocyte. However, drug-induced proarrhythmic potential can be different when cardiomyocytes are surrounded by non-muscle cells. Incorporating fibroblasts in models of myocardium is important particularly for predicting a drugs cardiac liability in the aging population - a growing population who take more medications and exhibit increased cardiac fibrosis...
April 26, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28434969/translational-science-approach-for-assessment-of-cardiovascular-effects-and-proarrhythmogenic-potential-of-the-beta-3-adrenergic-agonist-mirabegron
#8
Cees Korstanje, Masanori Suzuki, Koichiro Yuno, Shuichi Sato, Masashi Ukai, Marlowe J Schneidkraut, Gan X Yan
INTRODUCTION: Translational assessment of cardiac safety parameters is a challenge in clinical development of beta-3 adrenoceptor agonists. The preclinical tools are presented that were used for assessing human safety for mirabegron. METHODS: Studies were performed on electrical conductance at ion channels responsible for cardiac repolarization (IKr, IKs, Ito, INa, and ICa,L), on QT-interval, subendocardial APD90, Tpeak-end interval, and arrhythmia's in ventricular dog wedge tissue in vitro and on cardiovascular function (BP, HR, and QTc) in conscious dogs...
April 20, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28434968/cardiac-contractility-correction-strategies-applied-to-telemetry-data-from-a-hesi-sponsored-consortium
#9
Emmanuel Boulay, Michael K Pugsley, Vincent Jacquemet, Alain Vinet, Michael V Accardi, Maxim Soloviev, Eric Troncy, Jennifer M Doyle, Jennifer Beck Pierson, Simon Authier
INTRODUCTION: QT has a long history of heart rate (HR) correction but limited investigations have been undertaken to assess the impact of cardiovascular parameters on left ventricular (LV) contractility in drug safety testing. Cardiac contractility is affected by preload (Cyon-Frank-Starling law), afterload (Anrep effect) and HR (Bowditch effect). We evaluated multi-parameter correction methods to help with dP/dtmax interpretation. METHODOLOGY: Modeling was undertaken using data from dogs in single or double 4×4 Latin square studies...
April 20, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28428100/an-overview-of-the-safety-pharmacology-career-of-dr-c-r-hassler
#10
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
#11
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
#12
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
#13
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
#14
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 11, 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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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