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Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries.
The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines)Expand
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Reducing blood volume requirements for clinical pathology testing in toxicologic studies-points to consider.
In preclinical safety assessment, blood volume requirements for various endpoints pose a major challenge. The goal of this working group was to review current practices for clinical pathology (CP)Expand
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Biomarkers in Nonclinical Drug Development
Abstract In the context of nonclinical drug development, a biomarker may be defined as any specific parameter that is objectively measured and evaluated as an indicator of normal biologicalExpand
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Optimized Processing of Fine-Needle Lymph Node Biopsies for Automated Immunostaining
A straightforward, reliable technique for postcollection processing and evaluation of cytologic specimens for antigen detection using an automated immunostainer was developed. Visual assessment ofExpand
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Influence of Study Design Variables on Clinical Pathology Data
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 isExpand
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Cytological Bone Marrow Cell Differential Counts and Morphologic Findings in Healthy Cynomolgus Monkeys (Macaca fascicularis) from Nonclinical Toxicology Studies
Cytological bone marrow evaluation is utilized in nonclinical toxicology studies to characterize hematopoietic effects when the combined interpretation of histologic and complete blood count dataExpand
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Overview and considerations for the reporting of clinical pathology interpretations in nonclinical toxicology studies.
Clinical pathology reporting practices are diverse among individuals and organizations involved in nonclinical toxicology studies. Clear, informative, and consistent reporting of clinical pathologyExpand
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Factors affecting urine reagent strip blood results in dogs and nonhuman primates and interpretation of urinalysis in preclinical toxicology studies: a Multi-Institution Contract Research
BACKGROUND Urinalysis data in preclinical toxicology studies can be influenced by preanalytic and analytic factors which have the potential to confound interpretation. There is a paucity ofExpand
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Interpretative considerations for clinical pathology findings in nonclinical toxicology studies.
The interpretation of clinical pathology results from nonclinical safety studies is a fundamental component in hazard identification of new drug candidates. The ever-increasing complexity ofExpand
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Deciphering Sources of Variability in Clinical Pathology
The objectives of this session were to explore causes of variability in clinical pathology data due to preanalytical and analytical variables as well as study design and other procedures that occurExpand
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