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Toxicologic Pathology

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https://www.readbyqxmd.com/read/28641507/the-acvp-stp-coalition-for-veterinary-pathology-fellows-celebrates-32-new-training-positions
#1
Gary Cockerell, Cory Brayton, Anne Barger, Brad Bolon
Since its creation in 2004, the Coalition for Veterinary Pathology Fellows, a partnership between the American College of Veterinary Pathologists and the Society of Toxicologic Pathology, has established 32 new training positions backed by US$7.4 million in financial support from private sponsors.
June 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28641506/regulatory-forum-opinion-piece-imaging-applications-in-toxicologic-pathology-recommendations-for-use-in-regulated-nonclinical-toxicity-studies
#2
Robert R Maronpot, Abraham Nyska, Sean P Troth, Kathleen Gabrielson, Polina Sysa-Shah, Vyacheslav Kalchenko, Yuri Kuznetsov, Alon Harmelin, Yael S Schiffenbauer, David Bonnel, Jonathan Stauber, Yuval Ramot
Available imaging systems for use in preclinical toxicology studies increasingly show utility as important tools in the toxicologic pathologist's armamentarium, permit longitudinal evaluation of functional and morphological changes in tissues, and provide important information such as organ and lesion volume not obtained by conventional toxicology study parameters. Representative examples of practical imaging applications in toxicology research and preclinical studies are presented for ultrasound, positron emission tomography/single-photon emission computed tomography, optical, magnetic resonance imaging, and matrix-assisted laser desorption ionization-imaging mass spectrometry imaging...
June 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28641505/in-utero-exposure-to-di-n-butyl-phthalate-induces-morphological-and-biochemical-changes-in-rats-postpuberty
#3
Yuya Okayama, Shin Wakui, Michael F Wempe, Mitsuru Sugiyama, Masaya Motohashi, Tomoko Mutou, Hiroyuki Takahashi, Eisuke Kume, Hiroshi Ikegami
Pregnant Sprague-Dawley rats were orally administered di( n-butyl)phthalate (DBP; 100 mg/kg/day) on gestation days (GD) 12 to 21. We investigated the male offspring and probed morphological alterations in Sertoli cells at 7, 9, 14, and 17 weeks of age. Parameters assessed in this study included offspring number, sex ratios, body weights, testis weights, seminiferous tubule (ST) profile numbers and diameters, number of vimentin-labeled Sertoli cells, and both testosterone and follicle-stimulating hormone (FSH) levels...
June 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28421969/dystrophic-mineralization-of-costal-cartilage-in-hartley-guinea-pigs
#4
Alexandria M Schauer, Adrienne Schucker, Cathy S Carlson
Hartley guinea pigs are widely used animal models of disease, particularly in studies of osteoarthritis. The purpose of this study was to investigate lesions in the costal cartilage from 16 male, 5- to 6-month-old Hartley guinea pigs. Routine histological sections from the costal cartilage and costochondral junction (longitudinal and cross sections) and sternum (for evaluation of bone marrow) were examined. All 16 (100%) animals had histological lesions involving the costal cartilage that included matrix degeneration and mineralization, reduced cellularity, and evidence of chondrocyte necrosis...
April 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28421968/chronic-toxicology-studies-of-basal-insulin-peglispro-in-rats-and-dogs-a-novel-pegylated-insulin-lispro-analog-with-a-prolonged-duration-of-action
#5
Richard A Byrd, Jamie L Blackbourne, Mary Pat Knadler, Albert E Schultze, John L Vahle
Basal insulin peglispro (BIL) consists of insulin lispro with a 20-kDa polyethylene glycol (PEG) moiety covalently attached to lysine B28. Because chronic parenteral administration of PEGylated proteins to animals has sometimes resulted in PEG vacuolation of tissue macrophages, renal tubular cells, and choroid plexus ependymal cells, we investigated whether chronic subcutaneous (sc) injection of BIL in rats (52 weeks) and dogs (39 weeks) was associated with systemic toxicities or other changes, including vacuolation of tissue macrophages, renal tubular cells, and ependymal cells...
April 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28421967/lung-tumor-induction-by-26-week-dermal-application-of-1-2-dichloroethane-in-cb6f1-tg-rash2-mice
#6
Mayuko Suguro, Takamasa Numano, Mayumi Kawabe, Yuko Doi, Norio Imai, Yukinori Mera, Seiko Tamano
Short-term alternatives to traditional 2-year carcinogenic studies in rodents are being actively pursued. Recently, a 26-week short-term carcinogenicity study using CB6F1-Tg rasH2@Jcl (rasH2) mice has become a worldwide standard for the evaluation of chemical carcinogenesis. However, an acceptable short-term carcinogenic study model for dermally applied products is still lacking. To investigate the suitability of using the rasH2 mouse to test carcinogenic potential, 1,2-dichloroethane (1,2-DCE) was dermally applied to rasH2 mice: 1,2-DCE is a known carcinogen that causes lung bronchiolo-alveolar adenomas and adenocarcinomas when administered topically, orally, or by inhalation exposure; 1,2-DCE at a dose level of 126 mg/mouse in 200 μl acetone or acetone alone (vehicle control) was applied to the dorsal skin of 10 mice of each sex 3 times a week for 26 weeks...
April 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28421966/regulatory-forum-review-utility-of-in-vitro-secondary-pharmacology-data-to-assess-risk-of-drug-induced-valvular-heart-disease-in-humans-regulatory-considerations
#7
REVIEW
Thomas Papoian, Gowraganahalli Jagadeesh, Muriel Saulnier, Natalie Simpson, Arippa Ravindran, Baichun Yang, Adebayo A Laniyonu, Imran Khan, Ana Szarfman
Drug-induced valvular heart disease (VHD) is a serious side effect linked to long-term treatment with 5-hydroxytryptamine (serotonin) receptor 2B (5-HT2B) agonists. Safety assessment for off-target pharmacodynamic activity is a common approach used to screen drugs for this undesired property. Such studies include in vitro assays to determine whether the drug is a 5-HT2B agonist, a necessary pharmacological property for development of VHD. Measures of in vitro binding affinity (IC50, Ki) or cellular functional activity (EC50) are often compared to maximum therapeutic free plasma drug levels ( fCmax) from which safety margins (SMs) can be derived...
April 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28351296/regulatory-forum-opinion-piece-use-and-utility-of-animal-models-of-disease-for-nonclinical-safety-assessment-a-pharmaceutical-industry-survey
#8
Sherry J Morgan, Jessica Couch, Peggy Guzzie-Peck, Douglas A Keller, Ray Kemper, Monicah A Otieno, Robert J Schulingkamp, Thomas W Jones
An Innovation and Quality (IQ) Consortium focus group conducted a cross-company survey to evaluate current practices and perceptions around the use of animal models of disease (AMDs) in nonclinical safety assessment of molecules in clinical development. The IQ Consortium group is an organization of pharmaceutical and biotechnology companies with the mission of advancing science and technology. The survey queried the utilization of AMDs during drug discovery in which drug candidates are evaluated in efficacy models and limited short-duration non-Good Laboratory Practices (GLP) toxicology testing and during drug development in which drug candidates are evaluated in GLP toxicology studies...
April 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28349785/inflammatory-cell-findings-in-the-female-rabbit-heart-and-stress-associated-exacerbation-with-handling-and-procedures-used-in-nonclinical-studies
#9
Rani S Sellers, Ingrid Pardo, George Hu, K Nasir Khan, Richard Perry, Victoria Markiewicz, Cynthia Rohde, Jennifer Colangelo, William Reagan, David Clarke
Despite the use of rabbits in biomedical research, including regulatory toxicology and cardiovascular studies, little data exist on heart findings in this species. This study was designed to document myocardial findings in female rabbits and the impact of study-related procedures typical for vaccine toxicology studies. One hundred and forty 6- to 8-month-old female New Zealand White rabbits were divided equally into 2 groups, high and low study procedure groups (group 1 and group 2, respectively). All animals received intramuscular (IM) injections of sterile saline every 2 weeks for 5 times and were necropsied 2 days after the final IM injection...
April 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28345450/erratum
#10
(no author information available yet)
Weber, K. (2017). Differences in Types and Incidence of Neoplasms in Wistar Han and Sprague-Dawley Rats. J Toxicol Pathol45, 64-75. (Original DOI: 10.1177/0192623316672075) In the January 2017 issue of Toxicologic Pathology, a number of in text Table citations were incorrectly labeled. The following are the sentences with corrected Table number (this has also been corrected in the online version): Many fewer neoplasms are recorded for the endocrine pancreas compared with islet cell tumor incidences (Table 3)...
April 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28136187/particle-induced-pulmonary-alveolar-proteinosis-and-subsequent-inflammation-and-fibrosis-a-toxicologic-and-pathologic-review
#11
REVIEW
Ernst M Bomhard
This review analyzes the published data on cases of pulmonary alveolar proteinosis (PAP) in workers inhaling crystalline aluminum, indium, silicon, and titanium particles and possible sequelae, that is, inflammation and fibrosis, and compares these findings with those from animal experiments. In inhalation studies in rodents using crystalline indium and gallium compounds, pronounced PAP followed by inflammation and fibrosis down to very low concentration ranges have been reported. Crystalline aluminum, silicon, and titanium compounds also induced comparable pulmonary changes in animals, though at higher exposure levels...
April 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28178900/influence-of-study-design-variables-on-clinical-pathology-data
#12
Adam Aulbach, Anne Provencher, Niraj Tripathi
A number of factors related to study design have the potential to impact clinical pathology test results during the conduct of nonclinical safety studies. A thorough understanding of these factors is paramount in drawing accurate conclusions from clinical pathology data generated during such studies, particularly when attempting to make the distinction between test article and nontest article-related effects. Study design and conduct variables with potential to impact clinical pathology data discussed in this overview include those related to species and test system, animal age, animal care and husbandry practices, fasting, acclimatization periods, effects of transportation and stressors, route of administration, effects of in-life and surgical procedures, influence of study length, timing of blood collections, impact of vehicle/formulation composition, and some general concepts related to drug class...
February 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28178899/recognizing-and-reducing-analytical-errors-and-sources-of-variation-in-clinical-pathology-data-in-safety-assessment-studies
#13
A E Schultze, A R Irizarry
Veterinary clinical pathologists are well positioned via education and training to assist in investigations of unexpected results or increased variation in clinical pathology data. Errors in testing and unexpected variability in clinical pathology data are sometimes referred to as "laboratory errors." These alterations may occur in the preanalytical, analytical, or postanalytical phases of studies. Most of the errors or variability in clinical pathology data occur in the preanalytical or postanalytical phases...
February 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28178898/deciphering-sources-of-variability-in-clinical-pathology-it-s-not-just-about-the-numbers
#14
Nancy E Everds
Preanalytical variables can have significant impacts on clinical pathology parameters evaluated during the conduct of a nonclinical safety or toxicity study. These preanalytical variables can be controlled by careful attention to factors such as animal dietary status (diet composition, fasted, and fed state), restraint and anesthesia, intercurrent procedures, timing of clinical pathology collections, and proficiency of animal technicians. The impact of preanalytical variables on test results can be significant enough to result in difficult interpretations and/or regulatory questions or can obfuscate the effects of a test article...
February 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28178897/contemporary-and-emerging-applications-in-clinical-pathology
#15
Adam D Aulbach, Holly Jordan, Jacqueline Tarrant
No abstract text is available yet for this article.
February 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28056663/principles-for-assessing-adversity-in-toxicologic-clinical-pathology
#16
Lila Ramaiah, Lindsay Tomlinson, Niraj K Tripathi, Laura C Cregar, Allison Vitsky, Barbara von Beust, Valerie G Barlow, William J Reagan, Daniela Ennulat
There is limited direction in the literature or regulatory guidance on determination of adversity for clinical pathology (CP) biomarkers in preclinical safety studies. Toxicologic clinical pathologists representing the American Society for Veterinary Clinical Pathology-Regulatory Affairs Committee and Society of Toxicologic Pathology-Clinical Pathology Interest Group identified principles, overall approach, and unique considerations for assessing adversity in CP data interpretation to provide a consensus opinion...
February 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28013573/evaluation-of-mir-216a-and-mir-217-as-potential-biomarkers-of-acute-exocrine-pancreatic-toxicity-in-rats
#17
Jianying Wang, Wenhu Huang, Stephane Thibault, Thomas P Brown, Walter Bobrowski, Hovhannes J Gukasyan, Winston Evering, Wenyue Hu, Annette John-Baptiste, Allison Vitsky
Detecting and monitoring exocrine pancreatic damage during nonclinical and clinical testing is challenging because classical biomarkers amylase and lipase have limited sensitivity and specificity. Novel biomarkers for drug-induced pancreatic injury are needed to improve safety assessment and reduce late-stage attrition rates. In a series of studies, miR-216a and miR-217 were evaluated as potential biomarkers of acute exocrine pancreatic toxicity in rats. Our results revealed that miR-216a and miR-217 were almost exclusively expressed in rat pancreas and that circulating miR-216a and miR-217 were significantly increased in rats following administration of established exocrine pancreatic toxicants caerulein (CL) and 1-cyano-2-hydroxy-3-butene (CHB) as well as in rats administered a proprietary molecule known to primarily affect the exocrine pancreas...
February 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28007014/evaluation-of-pepsinogen-i-as-a-biomarker-of-drug-induced-gastric-mucosal-injury-in-cynomolgus-monkeys
#18
Daniela Ennulat, Karen M Lynch, Carie L Kimbrough, Rosanna C Mirabile, Sabine Rehm
Gastric mucosal injury is frequently observed in nonclinical studies of nonhuman primates. Because microscopic evaluation of stomach is generally a terminal procedure, our objective was to determine whether serum pepsinogen I (PG I) could serve as a noninvasive biomarker for detection of gastric mucosal injury in monkey. Serum PG I was measured using a commercial human immunoassay in cynomolgus monkeys ( n = 166) prior to dosing and/or terminally in 11 studies of up to 1 month duration. Mean ( SD) PG I values (ug/L) for monkeys with ( n = 59) and without ( n = 100) gastric mucosal degeneration were 101 (215) and 28 (12...
February 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/27879436/cytological-bone-marrow-cell-differential-counts-and-morphologic-findings-in-healthy-cynomolgus-monkeys-macaca-fascicularis-from-nonclinical-toxicology-studies
#19
Caitlyn M Carter, Laura C Cregar, Adam D Aulbach
Cytological bone marrow evaluation is utilized in nonclinical toxicology studies to characterize hematopoietic effects when the combined interpretation of histologic and complete blood count data does not yield sufficient information. Results from cytological bone marrow examination should be interpreted in the context of variability observed in concurrent control animals with consideration of cytologist experience and historical/published data. Cytological bone marrow differential counts and cellular morphologic findings from 130 (66 male, 64 female) healthy control cynomolgus monkeys from nonclinical toxicology studies were retrospectively analyzed...
February 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/27729587/practical-considerations-in-clinical-pathology-data-interpretation-and-description
#20
Robert L Hall
Although interpretation and description of clinical pathology test results for any preclinical safety assessment study should employ a consistent standard approach, companies differ regarding that approach and the appearance of the end product. Some rely heavily on statistical analysis, others do not. Some believe reference intervals are important, most do not. Some prefer severity of effects be described by percentage differences from, or multiples of, baseline or control, others prefer only word modifiers...
February 2017: Toxicologic Pathology
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