当前位置： SCI文献检索 > TOXICOLOGY AND APPLIED PHARMACOLOGY期刊下所有文献 > Analysis of the safety and pharmacodynamics of human fibrinogen concentrate in animals.

Analysis of the safety and pharmacodynamics of human fibrinogen concentrate in animals.

Abstract：

:Fibrinogen, a soluble 340kDa plasma glycoprotein, is critical in achieving and maintaining hemostasis. Reduced fibrinogen levels are associated with an increased risk of bleeding and recent research has investigated the efficacy of fibrinogen concentrate for controlling perioperative bleeding. European guidelines on the management of perioperative bleeding recommend the use of fibrinogen concentrate if significant bleeding is accompanied by plasma fibrinogen levels less than 1.5-2.0g/l. Plasma-derived human fibrinogen concentrate has been available for therapeutic use since 1956. The overall aim of the comprehensive series of non-clinical investigations presented was to evaluate i) the pharmacodynamic and pharmacokinetic characteristics and ii) the safety and tolerability profile of human fibrinogen concentrate Haemocomplettan P® (RiaSTAP®). Pharmacodynamic characteristics were assessed in rabbits, pharmacokinetic parameters were determined in rabbits and rats and a safety pharmacology study was performed in beagle dogs. Additional toxicology tests included: single-dose toxicity tests in mice and rats; local tolerance tests in rabbits; and neoantigenicity tests in rabbits and guinea pigs following the introduction of pasteurization in the manufacturing process. Human fibrinogen concentrate was shown to be pharmacodynamically active in rabbits and dogs and well tolerated, with no adverse events and no influence on circulation, respiration or hematological parameters in rabbits, mice, rats and dogs. In these non-clinical investigations, human fibrinogen concentrate showed a good safety profile. This data adds to the safety information available to date, strengthening the current body of knowledge regarding this hemostatic agent.

journal_name

Toxicol Appl Pharmacol

journal_title

Toxicology and applied pharmacology

authors

Beyerle A,Nolte MW,Solomon C,Herzog E,Dickneite G

doi

10.1016/j.taap.2014.07.019

subject

Has Abstract

pub_date

2014-10-01 00:00:00

pages

70-7

issue

1

eissn

0041-008X

issn

1096-0333

pii

S0041-008X(14)00279-8

journal_volume

280

pub_type

杂志文章

相关文献

TOXICOLOGY AND APPLIED PHARMACOLOGY文献大全
  • Differential sensitivity of normal and H-ras oncogene-transformed rat kidney epithelial cells to okadaic acid-induced apoptosis.

    abstract：:H-ras oncogenes have been identified in greater than 50% of the most common forms of human neoplasia. Ras-related proteins have been postulated to mediated signal transduction pathways involving mitogen-activated protein (MAP) kinases and nuclear responses that may be involved in the induction of apoptosis. We examine...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1006/taap.1996.0264

    authors： Davis MA,Chang SH,Trump BF

    更新日期：1996-11-01 00:00:00

  • Modulation of farnesoid X receptor results in post-translational modification of poly (ADP-ribose) polymerase 1 in the liver.

    abstract：:The farnesoid X receptor (FXR) is a bile acid-activated transcription factor belonging to the nuclear receptor superfamily. FXR deficiency in mice results in cholestasis, metabolic disorders, and tumorigenesis in liver and intestine. FXR is known to contribute to pathogenesis by regulating gene transcription; however,...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2012.11.012

    authors： Zhu Y,Li G,Dong Y,Zhou HH,Kong B,Aleksunes LM,Richardson JR,Li F,Guo GL

    更新日期：2013-01-15 00:00:00

  • Increased serum bile acid concentration following low-dose chronic administration of thioacetamide in rats, as evidenced by metabolomic analysis.

    abstract：:A liquid chromatography/time-of-flight mass spectrometry (LC/TOF-MS)-based metabolomics approach was employed to identify endogenous metabolites as potential biomarkers for thioacetamide (TAA)-induced liver injury. TAA (10 and 30mg/kg), a well-known hepatotoxic agent, was administered daily to male Sprague-Dawley (SD)...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2015.07.016

    authors： Jeong ES,Kim G,Shin HJ,Park SM,Oh JH,Kim YB,Moon KS,Choi HK,Jeong J,Shin JG,Kim DH

    更新日期：2015-10-15 00:00:00

  • Reduced cytochrome P4501A activity and recovery from oxidative stress during subchronic benzo[a]pyrene and benzo[e]pyrene treatment of rainbow trout.

    abstract：:This study assessed the role of aryl hydrocarbon receptor (AHR) affinity, and cytochrome P4501A (CYP1A) protein and activity in polyaromatic hydrocarbon (PAH)-induced oxidative stress. In the 1-100nM concentration range benzo[a]pyrene (BaP) but not benzo[e]pyrene (BeP) competitively displaced 2nM [(3)H]2, 3, 7, 8-tetr...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2011.04.015

    authors： Curtis LR,Garzon CB,Arkoosh M,Collier T,Myers MS,Buzitis J,Hahn ME

    更新日期：2011-07-01 00:00:00

  • Late dimethyl sulfoxide administration provides a protective action against chemically induced injury in both the liver and the kidney.

    abstract：:Dimethyl sulfoxide (DMSO) can protect the liver from injury produced by a variety of hepatotoxicants when administered prior to or concomitant with the toxicants. This protective action has previously been attributed to DMSO-induced inhibition of bioactivation of the compounds to toxic intermediates. In these studies,...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1006/taap.1996.8009

    authors： Lind RC,Gandolfi AJ

    更新日期：1997-01-01 00:00:00

  • Gene expression profiling in the liver of CD-1 mice to characterize the hepatotoxicity of triazole fungicides.

    abstract：:Four triazole fungicides used in agricultural or pharmaceutical applications were examined for hepatotoxic effects in mouse liver. Besides organ weight, histopathology, and cytochrome P450 (CYP) enzyme induction, DNA microarrays were used to generate gene expression profiles and hypotheses on potential mechanisms of a...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2006.02.016

    authors： Goetz AK,Bao W,Ren H,Schmid JE,Tully DB,Wood C,Rockett JC,Narotsky MG,Sun G,Lambert GR,Thai SF,Wolf DC,Nesnow S,Dix DJ

    更新日期：2006-09-15 00:00:00

  • Modulation of p,p'-DDT-induced tremor by catecholaminergic agents.

    abstract：:p,p'-DDT (1,1,1-trichloro-2,2-bis(p-chlorophenyl)ethane; 75 mg/kg) or corn oil was administered po to male Fischer 344N rats. Tremor was quantified 8 hr later by spectral analysis of whole body movements. The effect of sc injection of pharmacological challenges on the spectral profile of body movements was determined....

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/0041-008x(87)90096-2

    authors： Herr DW,Tilson HA

    更新日期：1987-11-01 00:00:00

  • Enlightened protein: Fhit tumor suppressor protein structure and function and its role in the toxicity of protoporphyrin IX-mediated photodynamic reaction.

    abstract：:The Fhit tumor suppressor protein possesses Ap(3)A (diadenosine triphosphate - ApppA) hydrolytic activity in vitro and its gene is found inactive in many pre-malignant states due to gene inactivation. For several years Fhit has been a widely investigated protein as its cellular function still remains largely unsolved....

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章,评审

    doi：10.1016/j.taap.2009.08.023

    authors： Zawacka-Pankau J,Ferens B

    更新日期：2009-12-01 00:00:00

  • Oxidative stress suppression by luteolin-induced heme oxygenase-1 expression.

    abstract：:Luteolin, a flavonoid that exhibits antioxidative properties, exerts myocardial protection effects. However, the underlying molecular mechanisms are not yet fully understood. To investigate the effects of luteolin on myocardial injury protection and its possible mechanisms, a myocardial injury model was established wi...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2012.10.002

    authors： Sun GB,Sun X,Wang M,Ye JX,Si JY,Xu HB,Meng XB,Qin M,Sun J,Wang HW,Sun XB

    更新日期：2012-12-01 00:00:00

  • Role of TNFR1 in lung injury and altered lung function induced by the model sulfur mustard vesicant, 2-chloroethyl ethyl sulfide.

    abstract：:Lung toxicity induced by sulfur mustard is associated with inflammation and oxidative stress. To elucidate mechanisms mediating pulmonary damage, we used 2-chloroethyl ethyl sulfide (CEES), a model sulfur mustard vesicant. Male mice (B6129) were treated intratracheally with CEES (3 or 6 mg/kg) or control. Animals were...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2010.10.027

    authors： Sunil VR,Patel-Vayas K,Shen J,Gow AJ,Laskin JD,Laskin DL

    更新日期：2011-02-01 00:00:00

  • Inhibitory effect of putranjivain A on allergic inflammation through suppression of mast cell activation.

    abstract：:A great number of people are suffering from allergic inflammatory disease such as asthma, atopic dermatitis, and sinusitis. Therefore discovery of drugs for the treatment of these diseases is an important subject in human health. Putranjivain A (PJA), member of ellagitannin, is known to possess beneficial effects incl...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2013.12.006

    authors： Kim HH,Park SB,Lee S,Kwon TK,Shin TY,Park PH,Lee SH,Kim SH

    更新日期：2014-02-01 00:00:00

  • Gene expression influences on metal immunomodulation.

    abstract：:Heavy metals in the environment originate from both human activities and natural processes. Exposure to these metals can result in important changes to immune activity. Depending on the metal and dose, these changes can result in enhanced immune function, diminished immune responses, or altered responses that produce ...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章,评审

    doi：10.1016/j.taap.2005.04.021

    authors： Lynes MA,Fontenot AP,Lawrence DA,Rosenspire AJ,Pollard KM

    更新日期：2006-01-01 00:00:00

  • Enhanced hepatic expression of P450IIE1 following inhalation exposure to pyridine.

    abstract：:Previous research has shown that intraperitoneal injection of the solvent pyridine results in a dose- and time-dependent induction of hepatic P450IIE1 in rats, with a twofold increase observed at 6 hr post-treatment. However, inhalation is the primary route of exposure expected for humans exposed to pyridine in labora...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1006/taap.1993.1014

    authors： Hotchkiss JA,Kim SG,Novak RF,Dahl AR

    更新日期：1993-01-01 00:00:00

  • Acute trimethyltin intoxication in the monkey (Macaca fascicularis).

    abstract：:Adult cynomolgus monkeys were administered trimethyltin (TMT) iv in dosages ranging from 0.75 to 4.0 mg TMT/kg and observed for behavioral changes. Animals were subsequently killed for light and electron microscopic examination. TMT showed a dose-related toxicity, with high dose animals (4.0 and 3.0 mg/kg) dying withi...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/0041-008x(85)90141-3

    authors： Reuhl KR,Gilbert SG,Mackenzie BA,Mallett JE,Rice DC

    更新日期：1985-07-01 00:00:00

  • Tricyclic antidepressants inhibit human natural killer cells.

    abstract：:The commonly used antidepressants imipramine, amitriptyline, and nortriptyline were found to significantly inhibit human natural killer (NK) cell-mediated cytolysis in vitro and suppress the stimulation of NK cells by IFN-gamma. This is a previously unrecognized biologic property of these drugs with psychotropic activ...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1006/taap.1996.0068

    authors： Xiao L,Eneroth P

    更新日期：1996-04-01 00:00:00

  • Effects of phospholipid surfactant on apoptosis induction by respirable quartz and kaolin in NR8383 rat pulmonary macrophages.

    abstract：:Apoptosis was measured in rat alveolar macrophage NR8383 cells challenged in vitro with respirable quartz or kaolin dust and with the dusts pretreated with dipalmitoyl phosphatidylcholine (DPPC) to model conditioning of respired dusts by interaction with a primary phospholipid component of pulmonary surfactant. Quartz...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1006/taap.2001.9249

    authors： Gao N,Keane MJ,Ong T,Ye J,Miller WE,Wallace WE

    更新日期：2001-09-15 00:00:00

  • Mechanistic toxicogenomic analysis of WAY-144122 administration in Sprague-Dawley rats.

    abstract：:Application of global gene expression analysis in the study of mechanisms of toxicity could provide a more comprehensive interpretation of the molecular basis of drug action. WAY-144122 has pharmacological activity against several targets improving insulin responsiveness and favorably altering lipid profiles. Normal r...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2003.11.016

    authors： Peterson RL,Casciotti L,Block L,Goad ME,Tong Z,Meehan JT,Jordan RA,Vinlove MP,Markiewicz VR,Weed CA,Dorner AJ

    更新日期：2004-04-01 00:00:00

  • The area under the concentration-time curve of all-trans-retinoic acid is the most suitable pharmacokinetic correlate to the embryotoxicity of this retinoid in the rat.

    abstract：:Earlier studies with etretinate and its metabolite acitretin suggested that area under the concentration-time curve (AUC) is the most suitable pharmacokinetic correlate to etretinate-induced teratogenesis. In an attempt to test this hypothesis with respect to the embryotoxic effects of all-trans-retinoic acid (all-tra...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1006/taap.1997.8105

    authors： Tzimas G,Thiel R,Chahoud I,Nau H

    更新日期：1997-04-01 00:00:00

  • Female-specific activation of pregnane X receptor mediates sex difference in fetal hepatotoxicity by prenatal monocrotaline exposure.

    abstract：:Pyrrolizidine alkaloids (PAs) are a group of hepatic toxicant widely present in plants. Cytochrome P450 (CYP) 3A plays a key role in metabolic activation of PAs to generate electrophilic metabolites, which is the main cause of hepatotoxicity. We have previously demonstrated the sex difference in developmental toxicity...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2020.115137

    authors： Xiang E,Guo Q,Dai YG,Sun XX,Liu J,Fan CP,Wang YQ,Qiu SK,Wang H,Guo Y

    更新日期：2020-11-01 00:00:00

  • Tin salts prevent the plasma cell response to metallic tin in Lewis rats.

    abstract：:Inoculation of metallic tin powder produced marked proliferation of plasma cells and Russell body cells in draining lymph nodes. Prior, but not concurrent, administration of a soluble tin salt in the drinking water prevented the plasma cell hyperplasia. Various Na, Zn, Ag, and Cu salts were not inhibitory. The inhibit...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/0041-008x(83)90359-9

    authors： Levine S,Sowinski R

    更新日期：1983-03-30 00:00:00

  • Calcitriol ameliorated autonomic dysfunction and hypertension by down-regulating inflammation and oxidative stress in the paraventricular nucleus of SHR.

    abstract：:The hypothalamic paraventricular nucleus (PVN) plays crucial roles in central cardiovascular regulation. Increasing evidence in humans and rodents shows that vitamin D intake is important for achieving optimal cardiovascular function. The purpose of this study was to investigate whether calcitriol, an active form of v...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2020.114950

    authors： Xu ML,Yu XJ,Zhao JQ,Du Y,Xia WJ,Su Q,Du MM,Yang Q,Qi J,Li Y,Zhou SW,Zhu GQ,Li HB,Kang YM

    更新日期：2020-05-01 00:00:00

  • Cellular glutathione prevents cytolethality of monomethylarsonic acid.

    abstract：:Inorganic arsenicals are clearly toxicants and carcinogens in humans. In mammals, including humans, inorganic arsenic often undergoes methylation, forming compounds such as monomethylarsonic acid (MMAs(V)) and dimethylarsinic acid (DMAs(V)). However, much less information is available on the in vitro toxic potential o...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2003.11.022

    authors： Sakurai T,Kojima C,Ochiai M,Ohta T,Sakurai MH,Waalkes MP,Fujiwara K

    更新日期：2004-03-01 00:00:00

  • Balance between the toxicity and anticancer activity of arsenic trioxide in treatment of acute promyelocytic leukemia.

    abstract：:Arsenic trioxide (ATO) has a long history and it is recognized as both poison and drug for more than two thousand years. Since the establishment of ATO as a frontline therapeutic agent for acute promyelocytic leukemia (APL), the survival of APL patients have been greatly improved and APL is turned from highly fatal to...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章,评审

    doi：10.1016/j.taap.2020.115299

    authors： Wang QQ,Hua HY,Naranmandura H,Zhu HH

    更新日期：2020-12-15 00:00:00

  • Low level exposure to monomethyl arsonous acid-induced the over-production of inflammation-related cytokines and the activation of cell signals associated with tumor progression in a urothelial cell model.

    abstract：:Human bladder cancer has been associated with chronic exposure to arsenic. Chronic exposure of an immortalized non-tumorigenic urothelial cell line (UROtsa cells) to arsenicals has transformed these cells to a malignant phenotype, but the involved mechanisms are not fully understood. Chronic inflammation has been link...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2009.12.029

    authors： Escudero-Lourdes C,Medeiros MK,Cárdenas-González MC,Wnek SM,Gandolfi JA

    更新日期：2010-04-15 00:00:00

  • Attenuation of acute nitrogen mustard-induced lung injury, inflammation and fibrogenesis by a nitric oxide synthase inhibitor.

    abstract：:Nitrogen mustard (NM) is a toxic vesicant known to cause damage to the respiratory tract. Injury is associated with increased expression of inducible nitric oxide synthase (iNOS). In these studies we analyzed the effects of transient inhibition of iNOS using aminoguanidine (AG) on NM-induced pulmonary toxicity. Rats w...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2012.08.027

    authors： Malaviya R,Venosa A,Hall L,Gow AJ,Sinko PJ,Laskin JD,Laskin DL

    更新日期：2012-12-15 00:00:00

  • Trimethyltin effects on auditory function and cochlear morphology.

    abstract：:Trimethyltin (TMT) is a neurotoxicant known to alter auditory function. The present study was designed to compare TMT-induced auditory dysfunction using behavioral, electrophysiological, and anatomical techniques. Adult male Long-Evans hooded rats (n = 9-12/group) were acutely exposed to saline, 3, 5, or 7 mg/kg TMT. ...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/0041-008x(90)90364-z

    authors： Crofton KM,Dean KF,Ménache MG,Janssen R

    更新日期：1990-08-01 00:00:00

  • Detection and characterization of [3H]2,3,7,8-tetrachlorodibenzo-p-dioxin binding to Ah receptor in a rainbow trout hepatoma cell line.

    abstract：:Ah receptor was identified and characterized in cytosol and nuclear extracts from the rainbow trout hepatoma cell line RTH-149. The cytosolic receptor was detectable with both halogenated ([3H]2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)) and non-halogenated ([3H]3-methylcholanthrene and [3H]benzo[a]pyrene) aromatic hyd...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/0041-008x(90)90105-4

    authors： Lorenzen A,Okey AB

    更新日期：1990-10-01 00:00:00

  • New Bis copper complex ((Z) -4 - ((4-chlorophenyl) amino) -4-oxobut-2-enoyl) oxy): Cytotoxicity in 4T1 cells and their toxicogenic potential in Swiss mice.

    abstract：:Copper (II) complexes are promising in the development of new synthetic models for cancer treatment. In this context, we synthesized a new copper complex containing the pharmacophore group 1,4-dioxo-2-butenyl, the Bis(((Z)-4-((4-chlorophenyl) amino)-4-oxobut-2-enoyl)oxy) copper compound and we evaluated its antitumor ...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2018.08.004

    authors： de Oliveira EJT,Pessatto LR,de Freitas RON,Pelizaro BI,Rabacow APM,Vani JM,Monreal ACD,Mantovani MS,de Azevedo RB,Antoniolli-Silva ACMB,da Silva Gomes R,Oliveira RJ

    更新日期：2018-10-01 00:00:00

  • p-aminophenol nephrotoxicity: biosynthesis of toxic glutathione conjugates.

    abstract：:p-Aminophenol causes necrosis of the pars recta of the proximal tubules in rats, and its nephrotoxicity may be due to glutathione-dependent bioactivation reactions. We have investigated the hepatic metabolism of p-aminophenol in Wistar rats and the cytotoxicity of formed glutathione S-conjugates in rat renal epithelia...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/0041-008x(92)90372-y

    authors： Klos C,Koob M,Kramer C,Dekant W

    更新日期：1992-07-01 00:00:00

  • Disruption of period gene expression alters the inductive effects of dioxin on the AhR signaling pathway in the mouse liver.

    abstract：:The aryl hydrocarbon receptor (AhR) and AhR nuclear translocator (ARNT) are transcription factors that express Per-Arnt-Sim (PAS) DNA-binding motifs and mediate the metabolism of drugs and environmental toxins in the liver. Because these transcription factors interact with other PAS genes in molecular feedback loops f...

    journal_title：Toxicology and applied pharmacology

    pub_type： 杂志文章

    doi：10.1016/j.taap.2008.10.016

    authors： Qu X,Metz RP,Porter WW,Cassone VM,Earnest DJ

    更新日期：2009-02-01 00:00:00