Regulatory Forum Opinion Piece*: An Experienced Pathologist Should Be Present at Necropsy for Novel Medical Device Studies.

abstract：:Highly standardized and controlled inhalation studies are required for hazard identification to make test results reproducible and comparable and to fulfill general regulatory requirements for the registration of new drugs, pesticides, or chemicals. Despite significant efforts, the results of inhalation studies have t...

journal_title：Toxicologic pathology

authors： Pauluhn J,Mohr U

更新日期：2000-09-01 00:00:00

abstract：:Recommendations (best practices) are provided by the Society of Toxicologic Pathology's Adversity Working Group for making consistent interpretations of test article-related effects as "adverse" and assigning a "no observed adverse effect level" (NOAEL) in nonclinical toxicity studies. Adverse is a term indicating "ha...

journal_title：Toxicologic pathology

authors： Kerlin R,Bolon B,Burkhardt J,Francke S,Greaves P,Meador V,Popp J

更新日期：2016-02-01 00:00:00

abstract：:A semiautomated quantitative assay for rat serum alkaline phosphatase (ALP) isoenzyme determination was developed, incorporating selective precipitation of bone alkaline phosphatase (BALP) with wheat germ lectin and differential inhibition with levamisole for determination of intestinal alkaline phosphatase (IALP). Th...

journal_title：Toxicologic pathology

authors： Hoffmann WE,Everds N,Pignatello M,Solter PF

更新日期：1994-11-01 00:00:00

abstract：:One of the major roles for the toxicologic pathologists now and into the future will be to determine the biologic significance of chemically induced biochemical and molecular alterations detected in whole tissue homogenates or cell cultures. The biologically significant effects will then require further analysis to de...

journal_title：Toxicologic pathology

authors： Miller RT,Davis BJ

更新日期：2001-01-01 00:00:00

abstract：:Many goitrogenic xenobiotics that increase the incidence of thyroid tumors in rodents exert a direct effect on the thyroid gland to disrupt one of several possible steps in the biosynthesis, secretion, and metabolism of thyroid hormones. This includes (a) inhibition of the iodine trapping mechanism, (b) blockage of or...

journal_title：Toxicologic pathology

authors： Capen CC

更新日期：1997-01-01 00:00:00

abstract：:Oxidant generation catalyzed by metals has been postulated to account for a lung injury following exposure to air pollution particles. In particles that are predominantly carbonaceous, it is difficult to implicate such an oxidative stress as the responsible mechanism, since concentrations of metals can be extremely lo...

journal_title：Toxicologic pathology

authors： Ghio AJ,Richards JH,Carter JD,Madden MC

更新日期：2000-07-01 00:00:00

abstract：:Seventeen mesotheliomas from 395 untreated male Fischer 344/DuCrj rats were studied by light and electron microscopy to define the morphological characteristics of the tumors. In 16 out of 17 rats, mesotheliomas were observed in the abdominal and/or scrotal sac, and the other one was localized on the pleura. Grossly, ...

journal_title：Toxicologic pathology

authors： Tanigawa H,Onodera H,Maekawa A

更新日期：1987-01-01 00:00:00

abstract：:Recombinant soluble CD4 (sT4) has been shown to inhibit infectivity of HIV. Because of the role CD4 plays in the interaction of T-helper lymphocytes and cells bearing MHC Class II antigens, a potential adverse effect of therapy with sT4 is interference with lymphocyte function. To address this issue, we studied the ef...

journal_title：Toxicologic pathology

authors： Bugelski PJ,Thiem PA,Truneh A,Morgan DG

更新日期：1991-01-01 00:00:00

abstract：:Analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs) are well recognized as a major class of therapeutic agent that causes renal papillary necrosis (RPN). Over the last decade a broad spectrum of other therapeutic agents and many chemicals have also been reported that have the potential to cause this lesion in...

journal_title：Toxicologic pathology

authors： Bach PH,Nguyen TK

更新日期：1998-01-01 00:00:00

abstract：:An annular, reddened lesion with mild serosal hemorrhage and no tumorous mass formation was detected in the right uterine horn of a 37-week-old female Sprague-Dawley rat that had postpubertal vaginal bleeding. Histological examination revealed prominent proliferation of the endometrium, which occupied the uterine lume...

journal_title：Toxicologic pathology

authors： Shirota M,Kawashima J,Nakamura T,Ogawa Y,Kamiie J,Shirota K

更新日期：2013-01-01 00:00:00

abstract：:This overview briefly summarizes the cellular pathobiology of experimental atherosclerosis and is then followed by a consideration of how 3 major risk factors interact with the hypothesized pathogenetic process. First, since hemodynamics and blood flow influence the localization of atherosclerotic plaques, possible me...

journal_title：Toxicologic pathology

authors： Getz GS

更新日期：1990-01-01 00:00:00

abstract：:Documentation of Chinese materia medica (CMM) dates back to around 1,100 BC when only dozens of drugs were first described. By the end of the 16th century, the number of drugs documented had reached close to 1,900. And by the end of the last century, published records of CMM have reached 12,800 drugs. The recorded tra...

journal_title：Toxicologic pathology

authors： Leung AY

更新日期：2006-01-01 00:00:00

abstract：:Toxicokinetic (TK) studies are the basis for demonstrating dose-related drug exposure in animals and for ensuring that drug exposure is substantially greater in animals than that expected in humans at therapeutic doses. The usefulness of TK studies can be further enhanced by correlating TK parameters with relevant tox...

journal_title：Toxicologic pathology

authors： Batra VK

更新日期：1995-03-01 00:00:00

abstract：:Novel urinary protein biomarkers for the detection of acute renal damage, recently accepted by the U.S. Food and Drug Administration, European Medicines Agency, and Pharmaceuticals and Medical Devices Agency (Japan), now have to be validated in practice. Limited data regarding the performance of these acute markers af...

journal_title：Toxicologic pathology

authors： Fuchs TC,Frick K,Emde B,Czasch S,von Landenberg F,Hewitt P

更新日期：2012-10-01 00:00:00

abstract：:Histopathologic examination of the testis from juvenile rats is often necessary to characterize the safety of new drugs for pediatric use and is a required end point in male pubertal development and thyroid function assays. To aid in evaluation and interpretation of the immature testis, the characteristic histologic f...

journal_title：Toxicologic pathology

authors： Picut CA,Remick AK,de Rijk EP,Simons ML,Stump DG,Parker GA

更新日期：2015-04-01 00:00:00

abstract：:Congenital intrahepatic arteriovenous fistulae, a rare hepatic vascular anomaly, in an 8-mo-old female beagle dog was investigated. The animal showed anorexia, repeated vomiting, hemorrhagic diarrhea, and jaundice for approximately 2 wk. There was mild to severe increase of serum alkaline phosphatase, glutamic-oxalace...

journal_title：Toxicologic pathology

authors： Yoshizawa K,Oishi Y,Matsumoto M,Fukuhara Y,Makino N,Noto T,Fujii T

更新日期：1997-09-01 00:00:00

abstract：:Changes in p53 expression, apoptosis and cell proliferation after treatment with 4-hydroxyaminoquinoline 1-oxide (4HAQO) were investigated in the rat pancreas and liver, target and nontarget organs for tumorigenesis, respectively. Male rats were given a single intravenous injection of 4HAQO at a dose of 20 mg/kg body ...

journal_title：Toxicologic pathology

authors： Imazawa T,Nishikawa A,Toyoda K,Furukawa F,Mitsui M,Hirose M

更新日期：2003-11-01 00:00:00

abstract：:Toxicology of the male reproductive system has received increased interest in recent years partly fuelled by the growing reports of falling sperm counts and rising reproductive disorders in the human population. Recently revised regulatory guidelines for the safety assessment of pharmaceuticals and chemicals on reprod...

journal_title：Toxicologic pathology

authors： Creasy DM

更新日期：1997-03-01 00:00:00

abstract：:Existing liver perfusion models are largely limited by high degrees of ischemic and reperfusion injury and the lack of standardization. To establish a highly standardized perfusion model and minimize reperfusion injury, a porcine liver perfusion model was developed using an artificial heart pump (Buecherl Artificial H...

journal_title：Toxicologic pathology

authors： Nagel S,Hegemann O,Groneberg DA,Grosse-Siestrup C

更新日期：2005-01-01 00:00:00

abstract：:Previous work in our laboratory revealed that the pubertal period of reproductive development in the male rat was particularly vulnerable to gossypol exposure, with a higher frequency of round structures in the lumen of the cauda epididymidis in the treated rats. Herein, we utilized hemicastration and electron microsc...

journal_title：Toxicologic pathology

authors： de Andrade SF,Oliva SU,Klinefelter GR,De Grava Kempinas W

更新日期：2006-01-01 00:00:00

abstract：:Focal spontaneously occurring eosinophilic hypertrophic cells, histomorphologically resembling oncocytes and hepatocytes, were observed in the pancreas from 11 (0.3%) of 4,177 Sprague-Dawley rats, 3 to 26 months old. The age of these eleven rats ranged from 13 to 25 months. The incidence was not different between sexe...

journal_title：Toxicologic pathology

authors： Chiu T

更新日期：1987-01-01 00:00:00

abstract：:We examined the effects of the quinolone antibacterial agents pefloxacin (PFLX) and ofloxacin (OFLX) on the Achilles tendon of Sprague-Dawley rats. A single oral administration of PFLX 300 and 900 mg/kg or OFLX 900 mg/kg induced edema with mononuclear cell infiltration mainly in the inner sheath of the inner Achilles ...

journal_title：Toxicologic pathology

authors： Kato M,Takada S,Kashida Y,Nomura M

更新日期：1995-05-01 00:00:00

abstract：:Statistical issues related to the design, analysis and interpretation of carcinogenicity studies are considered. A proposed modification of the "standard" National Cancer Institute (NCI) design of carcinogenicity studies in rodents is discussed. The primary objective was to obtain a design that maintained the power of...

journal_title：Toxicologic pathology

authors： Haseman JK

更新日期：1983-01-01 00:00:00

abstract：:Colorectal cancer, responsible for 50,000 deaths per year, is a contributing factor for considerable mortalities in the United States. Consumption of well-done red meat and saturated fats rich in polycyclic aromatic hydrocarbons may be one of the causative factors for sporadic colon cancer. The objective of this study...

journal_title：Toxicologic pathology

authors： Harris DL,Washington MK,Hood DB,Roberts LJ 2nd,Ramesh A

更新日期：2009-12-01 00:00:00

abstract：:Age-related changes in gross and microscopic structure of the nasal cavity may alter local tissue susceptibility as well as the dose of inhaled toxicant delivered to susceptible sites. This article describes a novel method for the use of magnetic resonance imaging, 3-dimensional airway modeling, and morphometric techn...

journal_title：Toxicologic pathology

authors： Carey SA,Minard KR,Trease LL,Wagner JG,Garcia GJ,Ballinger CA,Kimbell JS,Plopper CG,Corley RA,Postlethwait EM,Harkema JR,Einstein DR

更新日期：2007-01-01 00:00:00

abstract：:Oltipraz, developed as an antischistosomal agent, protects against the hepatotoxicity of many xenobiotics and is known to be an effective inhibitor of experimental carcinogenesis in rodents. In the present study, we investigated its effects on the development of lesions in LEC rats, established as a mutant strain char...

journal_title：Toxicologic pathology

authors： Nakamura H,Nishikawa A,Furukawa F,Kasahara K,Miyauchi M,Okazaki K,Imazawa T,Uchida K,Hirose M

更新日期：2002-03-01 00:00:00

abstract：:Overexpression of c-myc and transforming growth factor-alpha (TGF-alpha) has been frequently observed in human hepatocellular carcinoma (HCC),suggesting a pivotal role played by these protooncogenes in liver oncogenesis. In order to investigate the molecular events underlying human hepatic malignant transformation, we...

journal_title：Toxicologic pathology

authors： Calvisi DF,Thorgeirsson SS

更新日期：2005-01-01 00:00:00

abstract：:Duplications of the gastrointestinal tract are exceedingly rare in laboratory animals. We report a case of a communicating intestinal duplication in a 17-wk-old Sprague-Dawley (SD) rat. The duplication was present in the mesenteric border of the ileum, and both proximal and distal ends were communicated with the lumen...

journal_title：Toxicologic pathology

authors： Elangbam CS,Clevidence KJ,Jackson CB,Holson JF

更新日期：1998-03-01 00:00:00

abstract：:Alloxan-induced diabetic rats frequently exhibit proliferative lesions of squamous hyperplasia accompanied by chronic inflammation and Candida albicans infection in the forestomach, and some lesions progress to squamous cell carcinoma (SCC). Candida infection causes not only hyperplastic changes with inflammation but ...

journal_title：Toxicologic pathology

authors： Sano T,Ozaki K,Kodama Y,Matsuura T,Narama I

更新日期：2009-10-01 00:00:00

abstract：:Qualitative histopathology has been the gold standard for evaluation of morphological tissue changes in all organ systems, including the peripheral nervous system. However, the human eye is not sensitive enough to detect small changes in quantity or size. Peripheral nervous system toxicity can manifest as subtle chang...

journal_title：Toxicologic pathology

authors： Brown DL,Staup M,Swanson C

更新日期：2020-01-01 00:00:00