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Category Archive for: ‘EPL Services’

  • Ocular Toxicity Studies in Mammalian Nonrodent Species

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      While all ocular toxicity testing is specialized, ocular toxicity studies in nonrodent species require an even more “customized” level of planning and often different methods than those used in rodent (rat/mouse) studies. The species emphasized below are mammals with eyes much larger than those …

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  • EPL Announces New Manager of Laboratory Services

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    Experimental Pathology Laboratories, Inc. (EPL) is excited to announce that Daniel Zadory has been promoted to Manager, Laboratory Services at the Sterling, VA laboratory, effective July 1, 2020. Dan has been with EPL since 2008 and has progressed through laboratory and management roles, most recently …

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  • Nonrodent Species Gross Anatomic and Histologic Differences – Pathology Considerations

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    Anatomic species differences are an important consideration at every step of preclinical toxicity studies including the pathology phase. Not taking species differences into account can result not only in time-consuming and costly procedural problems but could affect study results and interpretation. The impact of these …

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  • Potential effect of coronavirus on cynomolgus monkey sources

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    Sponsors who plan to initiate toxicology studies in cynomolgus macaques should be aware that the coronavirus outbreak may have an impact on availability of mainland China origin macaques.  If necessary, substitution of macaques of other mainland Asia origin (e.g. Cambodia, Viet Nam) does not appear …

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  • EPL – Independent and Employee-Owned

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    Experimental Pathology Laboratories, Inc. (EPL) is an independent, private, employee-owned company that is recognized internationally for its ability to meet the needs of the scientific community and the challenges of preclinical safety testing and development with high quality histopathology services.  EPL was founded in 1971, …

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  • Use of Exposure-Response (ER) Modeling of QTc Data – A Movement Away from a Thorough QT Study

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    Since 2005 the US Food and Drug Administration (FDA) has required the evaluation of a new molecular entity in a thorough QT (TQT) study, which is intended to determine a drug’s effect on the QT interval.  The QT interval represents the duration of ventricular depolarization …

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  • Navigating the FDA Guidance for Nonclinical Abuse Liability Testing

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    The goal of this discussion is to help one understand and address the Food and Drug Administration’s Guidance for Industry, “Assessment of Abuse Potential of Drugs” Drug abuse is the intentional, non-therapeutic use of a drug or substance to achieve a desired psychological or physiological …

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  • Stereology: Probing for Precision

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    Stereology is a tool for obtaining unbiased estimates of object numbers and/or sizes within three-dimensional regions of interest.  For biological samples, quantitative measurements are potentially more objective and accurate when compared to traditional semi-quantitative grading of findings by pathologists (i.e., scoring of morphologic changes as …

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  • Blind Slide Reading

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    In toxicologic pathology, “blind slide reading” involves procedures in which the pathologist is unaware of the treatment group status of individual animals during the histologic slide evaluation phase of a toxicologic bioassay.  Blind slide reading continues to be a controversial topic, despite published recommendations on …

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  • Using Transmission Electron Microscopy in Preclinical Safety Studies

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    The use of Transmission Electron Microscopy (TEM) in preclinical studies has significantly waned in the last 20 or so years.  There are multiple reasons for this.  TEM is expensive and labor intensive.  Compared to standard histopathology, TEM requires significantly more time and money to analyze …

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