当前位置： SCI文献检索 > JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS期刊下所有文献 > Safety pharmacology methods and models in an evolving regulatory environment.

Safety pharmacology methods and models in an evolving regulatory environment.

Abstract：

: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. As the regulatory landscape is expected to evolve with revision announced for the existing guidance document on non-clinical proarrhythmia risk assessment (ICHS7B) there is also imminent inception of the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative. Thus, the field of SP is dynamically progressing with characterization and implementation of numerous alternative non-clinical safety models. Novel method development and refinement in all areas of the discipline are reflected in the content.

journal_name

J Pharmacol Toxicol Methods

journal_title

Journal of pharmacological and toxicological methods

authors

Pugsley MK,de Korte T,Authier S,Huang H,Accardi MV,Curtis MJ

doi

10.1016/j.vascn.2017.04.012

subject

Has Abstract

pub_date

2017-09-01 00:00:00

pages

1-6

eissn

1056-8719

issn

1873-488X

pii

S1056-8719(17)30097-7

journal_volume

87

pub_type

社论

相关文献

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS文献大全
  • HPLC determination of inorganic cation levels in CSF and plasma of conscious rabbits.

    abstract：:An HPLC method is described using conductimetric detection for the quantitative determination of sodium, potassium, magnesium, and calcium in cerebrospinal fluid (CSF) and plasma of conscious rabbits. This method enabled the four cations to be estimated with rapidity, sensitivity, accuracy, and precision. The mean mil...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/1056-8719(93)90057-l

    authors： Frosini M,Gorelli B,Matteini M,Palmi M,Valoti M,Sgaragli GP

    更新日期：1993-04-01 00:00:00

  • The PEG-switch assay: a fast semi-quantitative method to determine protein reversible cysteine oxidation.

    abstract：INTRODUCTION:Reversible protein cysteine oxidation is recognised as a pivotal post-transitional modification that transduces physiological as well as pathological signalling. Pharmacological interventions that target specific sources of oxidant formation are currently being trialled to ascertain their potential ability...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/j.vascn.2013.07.001

    authors： Burgoyne JR,Oviosu O,Eaton P

    更新日期：2013-11-01 00:00:00

  • A simple, automatic method for morphometric analysis of the left ventricle in rats with myocardial infarction.

    abstract：:Induction of acute myocardial infarction in the rat is an established model for studying effects of therapeutic interventions. Images of sections of the rat left ventricle, stained with nitroblue tetrazolium, were digitized and several parameters estimated by dedicated software on an image analyzer (IBAS 2.0). The met...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/1056-8719(95)00019-e

    authors： Porzio S,Masseroli M,Messori A,Forloni G,Olivetti G,Jeremic G,Riva E,Luvarà G,Latini R

    更新日期：1995-08-01 00:00:00

  • Early evaluation of compound QT prolongation effects: a predictive 384-well fluorescence polarization binding assay for measuring hERG blockade.

    abstract：INTRODUCTION:A large number of drugs from a variety of pharmacological classes have been demonstrated to cause adverse effects on cardiac rhythm, including the life-threatening arrhythmia Torsades de Pointes. These side effects are often associated with prolongation of the QT interval and are mediated via blockade of t...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/j.vascn.2006.09.003

    authors： Deacon M,Singleton D,Szalkai N,Pasieczny R,Peacock C,Price D,Boyd J,Boyd H,Steidl-Nichols JV,Williams C

    更新日期：2007-05-01 00:00:00

  • Assessment of two external telemetry systems (PhysioJacket and JET) in beagle dogs with telemetry implants.

    abstract：INTRODUCTION:Regulatory guidelines recommend the use of conscious, unrestrained animals for comprehensive cardiovascular safety assessment of a new therapeutic agent. Cardiovascular safety pharmacology studies normally use internal telemetry (surgical implants) in free-moving animals to monitor key ECG endpoints, like ...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/j.vascn.2009.04.196

    authors： Chui RW,Fosdick A,Conner R,Jiang J,Bruenner BA,Vargas HM

    更新日期：2009-07-01 00:00:00

  • The rat external urethral sphincter an in vitro model to evaluate the activity of drugs on the smooth and striated components of the urinary bladder outlet.

    abstract：:Electrical field stimulation (EFS, 2.5 Hz, 60 V, 1 ms, trains of 5 sec every 5 min) of the rat external urethral sphincter (EUS) produced contractile responses characterized by a "slow" tonic contraction on which was superimposed a series of phasic "twitch-like" contractions. Both responses were abolished by tetrodoto...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/1056-8719(92)90052-3

    authors： Parlani M,Manzini S,Argentino-Storino A,Conte B

    更新日期：1992-09-01 00:00:00

  • Rapid HPLC assay with coulometric detection for norepinephrine and 3-methoxy-4-hydroxyphenylglycol in the mouse brain.

    abstract：:For the rapid assay of norepinephrine (NE) and its major metabolite, 3-methoxy-4-hydroxyphenylglycol (MHPG) in the mouse brain, we developed a simple method using isocratic HPLC with coulometric detection. This method permits NE and MHPG assay within 5 min in one chromatographic run. Within-run coefficients of variati...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/1056-8719(94)90060-4

    authors： Murai S,Saito H,Masuda Y,Ohkubo N,Itoh T

    更新日期：1994-10-01 00:00:00

  • A simple method for measuring dopamine release from rat brain slices.

    abstract：:In many circumstances, rapid information is required about the effects of drugs on neurotransmitter release in brain, and a common method used is measurement of radiolabelled release from superfused brain slices or synaptosomes in vitro. However, the method requires expensive equipment and is not readily adapted to th...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/s1056-8719(97)00010-5

    authors： Thongsaard W,Kendall DA,Bennett GW,Marsden CA

    更新日期：1997-04-01 00:00:00

  • A novel approach for the determination of contractile and calcium responses of the basilar artery employing real-time confocal laser microscopy.

    abstract：INTRODUCTION:Intracellular calcium concentration ([Ca(2+)](i)) modifications in endothelial and smooth muscle cells represent a key element in the pathogenesis of cerebral artery vasospasm. Therefore, the present study documented potential application of confocal laser microscopy in the determination of contractile and...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/j.vascn.2007.03.002

    authors： Hashimoto T,Ohata H,Nobe K,Sakai Y,Honda K

    更新日期：2007-07-01 00:00:00

  • A modified aortic multiple-ring preparation for functional studies.

    abstract：:A comparison is made of four rat aortic preparations, that is, single ring, spiral strip, zig-zag strip, and multiple-ring, on the basis of the responses to norepinephrine (NE) and acetylcholine (ACh). The single ring preparation was suitable under isometric, but not under isotonic conditions, because of the small iso...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/1056-8719(96)00023-8

    authors： Calderone V,Martinotti E,Scatizzi R,Pellegrini A,Breschi MC

    更新日期：1996-06-01 00:00:00

  • A comparison of rectal and subcutaneous body temperature measurement in the common marmoset.

    abstract：:Two methods of measuring body temperature were compared in common marmosets. Subcutaneous temperatures were measured remotely via previously implanted subcutaneous microchips (Plexx BV, IPTT-100) prior to measurement of rectal temperature using a conventional rectal probe. Marmosets were treated with saline or the bra...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/s1056-8719(98)00030-6

    authors： Cilia J,Piper DC,Upton N,Hagan JJ

    更新日期：1998-07-01 00:00:00

  • Determination of nitric oxide generation in mammalian neurons using dichlorofluorescin diacetate and flow cytometry.

    abstract：:A method for the rapid detection of intracellular nitric oxide (NO) generation in dissociated cerebellar granule cells using dichlorofluorescin (DCFH) and flow cytometry was developed. DCFH can be oxidized specifically by NO and this was assessed by 1) the use of SIN-1 (10 nM-100 microM), an NO donor, that induced a c...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/s1056-8719(97)00066-x

    authors： Gabriel C,Camins A,Sureda FX,Aquirre L,Escubedo E,Pallàs M,Camarasa J

    更新日期：1997-10-01 00:00:00

  • Safety pharmacology in 2014: new focus on non-cardiac methods and models.

    abstract：:"What do you know about Safety Pharmacology?" This is the question that was asked in 2000 with the inception of the Safety Pharmacology Society (SPS). There is now a widespread awareness of the role of safety pharmacology in drug discovery and increasing awareness among the wider community of methods and models used i...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type：

    doi：10.1016/j.vascn.2014.08.004

    authors： Pugsley MK,Dalton JA,Authier S,Curtis MJ

    更新日期：2014-09-01 00:00:00

  • Evidence for a peripheral mechanism of action for the potentiation of the antinociceptive effect of morphine by dipyrone.

    abstract：:The potentiation of the antinociceptive effect of morphine by dipyrone (metamizol) and the possible participation of a peripheral mechanism on such synergism were studied with the use of the formalin test in the rat. Nociception was induced by the intraplantar injection of diluted formalin (1%) in the right hind paw. ...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/s1056-8719(00)00046-0

    authors： Aguirre-Bañuelos P,Granados-Soto V

    更新日期：1999-10-01 00:00:00

  • A fully validated simple new method for environmental monitoring by surface sampling for cytotoxics.

    abstract：:A wipe sampling procedure followed by a simple ultra-performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for simultaneous quantification of six cytotoxic drugs: 5-fluorouracil (5FU), doxorubicin (DOXO), epirubicin (EPI), ifosfamide (IF), cyclophosphamide (CP) an...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/j.vascn.2019.106652

    authors： Rossignol E,Amiand MB,Sorrieul J,Bard JM,Bobin-Dubigeon C

    更新日期：2020-01-01 00:00:00

  • Is pentobarbital appropriate for basal anesthesia in the working rat heart model?

    abstract：:In the present study we have examined the effects of the general anesthetic agents for the excision of the heart on the hemodynamic function of the ischemic perfused heart. Animals were divided into three groups. In one group rats were anesthetized with sodium pentobarbital intraperitoneally. Animals of the second and...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/1056-8719(93)90049-k

    authors： Oguchi T,Kashimoto S,Yamaguchi T,Nakamura T,Kumazawa T

    更新日期：1993-02-01 00:00:00

  • Assessment of drug-induced QT interval prolongation in conscious rabbits.

    abstract：INTRODUCTION:Most preclinical trials are designed to identify potential torsadogenicity test only for surrogates of torsade de pointes, most commonly prolongation of the heart rate corrected QT interval (QTc). This study was conducted to determine which correction method best accounts for the effects of changes in the ...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/j.vascn.2005.04.013

    authors： Kijtawornrat A,Ozkanlar Y,Keene BW,Roche BM,Hamlin DM,Hamlin RL

    更新日期：2006-03-01 00:00:00

  • Successful in vitro growth of rat two-cell embryos to blastocysts using a simple chemically defined medium.

    abstract：:The aim of the present study was to formulate a simple chemically defined medium for the in vitro growth of rat two-cell embryos to blastocysts. Embryos from day 2 pregnant rats were retrieved and placed in paraffin oil-covered droplets of "rat two-cell embryo culture medium" (R2ECM) containing combinations of various...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/s1056-8719(00)00084-8

    authors： Goh VH,Adiga SK,Tain CF,Tong TY,Ng SC

    更新日期：2000-05-01 00:00:00

  • Methodologic aspects of acetylcholine-evoked relaxation of rabbit aorta.

    abstract：:The acetylcholine-evoked relaxation of rabbit isolated thoracic aorta precontracted by phenylephrine was studied. Phenylephrine caused a steady contraction that was maintained for 6 h. In the presence of calcium disodium ethylenediaminetetraacetate (EDTA) and ascorbic acid the contraction decreased with time. N(G)-Nit...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/s1056-8719(99)00035-0

    authors： Hansen K,Nedergaard OA

    更新日期：1999-08-01 00:00:00

  • Characterization of an investigative safety pharmacology model to assess comprehensive cardiac function and structure in chronically instrumented conscious beagle dogs.

    abstract：INTRODUCTION:There has been an increasing need to conduct investigative safety pharmacology studies to complement regulatory-required studies, particularly as it applies to a comprehensive assessment of cardiovascular (CV) risk. METHODS:We describe refined methodology using a combination of telemetry and direct signal...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/j.vascn.2016.05.002

    authors： Regan CP,Stump GL,Detwiler TJ,Chen L,Regan HK,Gilberto DB,DeGeorge JJ,Sannajust FJ

    更新日期：2016-09-01 00:00:00

  • A simple method for measuring the effects of drugs on intestinal longitudinal and circular muscle.

    abstract：:A tissue preparation is described which makes it possible to examine the effect of drugs on the nerves that control both longitudinal and circular muscles of the small intestine. The preparation consists of a segment of rat ileum set up to measure the tension developed in the longitudinal muscle and intraluminal press...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/s1056-8719(96)00110-4

    authors： Coupar IM,Liu L

    更新日期：1996-11-01 00:00:00

  • A reliable procedure for comparison of antioxidants in rat brain homogenates.

    abstract：:Lipid peroxidation is a major consequence of oxidative stress and an important cause of neuronal damage in ischaemic injuries and neurodegenerative disorders such as Parkinson's disease. Recent research has focused on the development of antioxidant drugs which may delay or minimize neurodegeneration. Rapid and reliabl...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/s1056-8719(98)00022-7

    authors： Callaway JK,Beart PM,Jarrott B

    更新日期：1998-04-01 00:00:00

  • An animal model for the assessment of gingival lesions.

    abstract：:A model of gingival inflammation was performed in Sprague-Dawley rats weighing 180-200 g. Mechanical bamboo stick-induced injury was inflammatory when bacteria contaminated the sticks. Bacteria were first obtained from gingival fluid collected from a patient with adult periodontitis. Another strain from Institut Paste...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/1056-8719(94)90070-1

    authors： Guessous F,Huynh C,N'Guyen H,Godeau G,Giroud JP,Meyer J,Hornebeck W,Roch-Arveiller M

    更新日期：1994-11-01 00:00:00

  • Conscious and anesthetized non-human primate safety pharmacology models: hemodynamic sensitivity comparison.

    abstract：INTRODUCTION:Drug-induced cardiovascular effects identified in conscious cynomolgus monkeys equipped with tethers and prepared for radiotelemetry were compared with results from anesthetized non-human primate (cynomolgus and rhesus) models. METHODS:Remifentanil (4.0 microg/kg, bolus), esmolol (2.0 mg/kg, bolus) and do...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/j.vascn.2008.05.004

    authors： Authier S,Tanguay JF,Fournier S,Gauvin D,Legaspi M,Chaurand F,Breault C,Troncy E

    更新日期：2008-09-01 00:00:00

  • Method for the determination of the levels of beta-amyloid peptide in the CSF sampled from freely moving rats.

    abstract：INTRODUCTION:In the present study, a model was developed to determine the effect of secretase inhibition on beta-amyloid peptide (Abeta) levels in the cerebrospinal fluid (CSF) of freely moving adult rats. METHODS:Rats were chronically implanted with a cannula into the cisterna magna and CSF samples were collected at ...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/j.vascn.2005.02.002

    authors： El Mouedden M,Haseldonckx M,Mackie C,Meert T,Mercken M

    更新日期：2005-09-01 00:00:00

  • Physiologic and pharmacologic factors that affect myocardial relaxation.

    abstract：:Evaluation of the myocardial relaxation has become important in the last years. An impaired relaxation may precede contractile dysfunctions and even cause heart failure. To treat this impaired lusitropism it is necessary to properly assess the lusitropic state of the heart and understand how drugs affect the cellular ...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章,评审

    doi：10.1016/1056-8719(94)90011-6

    authors： Vittone L,Mundiña-Weilenmann C,Mattiazzi A,Cingolani H

    更新日期：1994-09-01 00:00:00

  • The method of long-term catheterization of the vena jugularis in pigs.

    abstract：INTRODUCTION:The pig is one of the most valuable in vivo models in biomedical research, however with only a few well-accessible veins suitable for venipuncture. Moreover, most of the known methods of blood collection are suitable only for a limited time period. The aim of the study was to verify an improved method of l...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/j.vascn.2019.106584

    authors： Klein P,Nalos L,Dejmek J,Soukup M

    更新日期：2019-01-01 00:00:00

  • Computer-aided video angiometry in isolated rabbit hearts: a new method assessing epicardial coronary selectivity.

    abstract：:The clinical value of coronary vasodilators in antianginal therapy depends on the ratio of their epicardial versus resistance coronary vessel actions. The coronary flow measured in standard isolated heart preparations, however, does not allow any conclusion about the function of epicardial vessels. Thus, we establishe...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/s1056-8719(97)00096-8

    authors： Joseph G,Strassberger F,Klaus W

    更新日期：1997-12-01 00:00:00

  • Characterization of [3H]apafant binding to PAF receptor on rabbit platelet membranes: a comparison of a microplate filtration system and a standard method.

    abstract：:This article describes the application of a Microplate Filtration System (MFS) to a binding assay, with the results being compared to those obtained with a conventional 24-Well Filtration Manifold (24WFM). The data reported here characterize the PAF receptor on rabbit platelet membranes using [3H]apafant. The results ...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/1056-8719(96)00074-3

    authors： Balsa D,Merlos M,Giral M,Ferrando R,García-Rafanell J,Forn J

    更新日期：1996-09-01 00:00:00

  • Adjustment of sensitisation and challenge protocols restores functional and inflammatory responses to ovalbumin in guinea-pigs.

    abstract：INTRODUCTION:Inhalation of antigen in atopic asthma induces early (EAR) and late asthmatic responses (LARs), inflammatory cell infiltration and airways hyperresponsiveness (AHR). Previously, we have established a protocol of sensitisation and subsequent ovalbumin (Ova) inhalation challenge in guinea-pigs which induced ...

    journal_title：Journal of pharmacological and toxicological methods

    pub_type： 杂志文章

    doi：10.1016/j.vascn.2014.10.007

    authors： Lowe AP,Broadley KJ,Nials AT,Ford WR,Kidd EJ

    更新日期：2015-03-01 00:00:00