Best Practices for Reporting Pathology Interpretations within GLP Toxicology Studies

Morton, Daniel G.; Kemp, Ramon K.; Francke-Carroll, Sabine; Jensen, Karl F.; McCartney, Jeffrey; Monticello, Thomas M.; Perry, Richard; Pulido, Olga; Roome, Nigel; Schafer, Kenneth A; Sellers, Rani S.; Snyder, Paul W.

doi:10.1080/01926230601034624

Cited by 58 publications

(47 citation statements)

References 3 publications

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“…The studies are scrutinized by the Food and Drug Administration (FDA) and other agencies, and best practices are reviewed regularly. 117,164,184,251 Methods and data are accessible from the NTP Web site (http://ntp.niehs. nih.gov/) or from PubMed (http://www.ncbi.nlm.nih.gov/pubmed).…”

Section: Experimental Designmentioning

confidence: 99%

“…The Society of Toxicologic Pathologists (STP) has published recommendations specifically on the peer-review process, 165,203,204 and the process is described in the Best Practices Guidelines for Toxicologic Histopathology. 34,58,164 Digital and Web-based technologies offer opportunities 78,178 for collaborative remote consulting and peer review of GEM pathology in aging and other phenotyping studies. 49,192 Veterinary and medical pathologists working in mouse pathology conduct or participate in these activities informally by emailing images or by multi-institution teleconferences, 49 but there is no formal review procedure for mouse pathology except by colleagues and journal reviewers.…”

Section: Grading Of Lesionsmentioning

confidence: 99%

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Pathobiology of Aging Mice and GEM

2012

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The use of induced and spontaneous mutant mice and genetically engineered mice (and combinations thereof) to study cancers and other aging phenotypes to advance improved functional human life spans will involve studies of aging mice. Genetic background contributes to pathology phenotypes and to causes of death as well as to longevity. Increased recognition of expected phenotypes, experimental variables that influence phenotypes and research outcomes, and experimental design options and rationales can maximize the utility of genetically engineered mice (GEM) models to translational research on aging. This review aims to provide resources to enhance the design and practice of chronic and longevity studies involving GEM. C57BL6, 129, and FVB/N strains are emphasized because of their widespread use in the generation of knockout, transgenic, and conditional mutant GEM. Resources are included also for pathology of other inbred strain families, including A, AKR, BALB/c, C3H, C57L, C58, CBA, DBA, GR, NOD.scid, SAMP, and SJL/J, and non-inbred mice, including 4WC, AB6F1, Ames dwarf, B6, 129, B6C3F1, BALB/c,129, Het3, nude, SENCAR, and several Swiss stocks. Experimental strategies for long-term cross-sectional and longitudinal studies to assess causes of or contributors to death, disease burden, spectrum of pathology phenotypes, longevity, and functional healthy life spans (health spans) are compared and discussed.

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Section: Experimental Designmentioning

confidence: 99%

Section: Grading Of Lesionsmentioning

confidence: 99%

Pathobiology of Aging Mice and GEM

2012

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“…Examples of ongoing classes include the Aquavet 1 II Comparative Pathology of Aquatic Animals Course [32] that is held yearly in the United States and the Short Course on Toxicologic Pathology in Fish [33], which is a European-based workshop conducted most recently at the University of Heidelberg, Germany. Examples of resources that are readily available include a number of guidance documents generated by the OECD and the USEPA that are specific to the evaluation of endocrine-active chemicals [34,35] and publications such as Wolf et al [11], which illustrates particular morphologic findings in fish tissues that are frequently either misdiagnosed or underdiagnosed, and also provides recommended practices for publishing fish histopathology data.…”

Section: Discussionmentioning

confidence: 99%

Evaluating the credibility of histopathology data in environmental endocrine toxicity studies

Wolf

Maack

2017

Enviro Toxic and Chemistry

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Agencies responsible for environmental protection are tasked with developing regulatory guidance that is based on the best available scientific evidence. Histopathology is a common endpoint in toxicologic bioassays; however, because of the subjective nature of this endpoint, and the advanced level of specialized training required for its effective utilization, the reliability of histopathology data can be inconsistent. Consequently, mechanisms for evaluating such data on a case-by-case basis are needed. The purposes of the present review are to describe a methodology that can be used to evaluate the credibility of histopathology findings and to discuss the results of such assessments as applied to real-world data collected from the scientific literature. A key outcome of these efforts was the finding that only 54% of the studies examined contained histopathology data that were considered to be either highly credible or credible, whereas data in 46% of those studies were of equivocal, dubious, or no credibility. In addition, the results indicated that the quality of the data examined tended to decline during the past 15 yr. The ultimate goals of the present review are to draw attention to reliability issues that can affect histopathology results, provide recommendations to improve the quality of this endpoint, and suggest an approach for the expeditious and judicious use of histopathology data in the weight-of-evidence determinations required for hazard and

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“…The histological gradings were defined to current situation in every case of histological changes [27,28]. The descriptions of the distinguishing features of each severity grade are presented in the following.…”

Section: Microscopic Findingsmentioning

confidence: 99%

BAG S53P4 putty as bone graft substitute – a rabbit model

Saarenpää¹,

Stoor²,

Frantzén³

2017

Biomedical Glasses

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Bioactive glass (BAG) S53P4 granules represent a bone augmentation biomaterial for the surgical treatment of bony defects, even in challenging conditions such as osteomyelitis. The aim of this eight-week rabbit implantation study was to evaluate the biocompatibility and bone regeneration performance of a BAG S53P4 putty formulation following its implantation into the proximal tibia bone of twenty-eight New Zealand white rabbits. BAG S53P4 putty was compared to BAG S53P4 granules (0.5-0.8 mm) to evaluate whether the synthetic putty binder influences the bone regeneration of the osteostimulative granules. The putty formulation facilitates clinical use because of its mouldability, injectability and ease of mixing with autograft. Implantation of putty and granules into proximal tibia defects resulted in good osseointegration of the two groups. Both biomaterials were biocompatible, showed high new bone formation, high vascularization and periosteal growth. No signs of disturbed bone formation were observed due to the PEG-glycerol binder in the BAG S53P4 putty. Instead, intramedullary ossification and stromal cell reaction were more advanced in the putty group compared to the control group (p = 0.001 and p < 0.001).In conclusion, the novel mouldable BAG S53P4 putty showed reliable bone regeneration in bony defects without adverse tissue or cell reactions.

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Best Practices for Reporting Pathology Interpretations within GLP Toxicology Studies

Cited by 58 publications

References 3 publications

Pathobiology of Aging Mice and GEM

Pathobiology of Aging Mice and GEM

Evaluating the credibility of histopathology data in environmental endocrine toxicity studies

BAG S53P4 putty as bone graft substitute – a rabbit model

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