Archives

Category Archive for: ‘EPL Services’

  • EPL’s SEND Capabilities

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    The Standard for Exchange of Nonclinical Data (SEND) provides preclinical study data standards that will allow for a more consistent and streamlined review process by the US FDA.  In general, SEND formats apply to studies started after Dec. 17, 2016 for NDAs, BLAs, and ANDAs, …

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  • Rabbit Eye Half

    A Closer Look at Ocular Toxicity Studies

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    The eye and the ocular adnexa are common target organs in toxicology studies, but the appropriate evaluation of ocular tissues is a specialized endeavor.   Compared to routine toxicity studies, ocular toxicity studies require methodological modifications at almost every stage from study design to the final …

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  • Stereology

    Stereology: Turn Up the Volume!

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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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  • DART

    EPL Necropsy Teams Capable of Providing Specialized DART Necropsies

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    We are pleased to announce that EPL’s necropsy teams have received specialized training in support of Developmental and Reproductive Toxicology (DART) necropsies.  Training in techniques used for DART studies was provided by Dr. Stephen Harris at Smithers Avanza Toxicology Services. DART training is focused primarily …

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  • Research and Development Pathology Support

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    EPL has extensive and diverse expertise and work experience in support of the pharmaceutical and biotechnology industries.  This includes supporting research from exploratory stages through submission of information to regulatory agencies and participating in follow-up actions to resolve questions arising from animal toxicity or efficacy studies. …

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  • Gamma-H2ZX Novel Biomarker for DNA Double-strand Breaks

    The Benefits of Immunohistochemistry (IHC)

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    Immunohistochemistry (IHC) has become a routinely used methodology for investigative and diagnostic evaluations that utilizes antigen-antibody reactions to identify antigens within cells or tissues.  While antigens are usually proteins, other antigenic biological products can also be recognized by antibodies including carbohydrates, lipids, nucleic acids, and …

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  • Retina

    Ocular Toxicity Studies: Specialized Necropsy, Histology, and Pathology Methods

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    The eye and the ocular adnexa are common target organs in toxicology studies, but the appropriate evaluation of ocular tissues is a specialized endeavor.  Compared to routine toxicity studies, ocular toxicity studies require methodological modifications at almost every stage from study design to the final …

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  • stereology

    Approaches to Design-Based Stereology

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    In contrast to two-dimensional image analysis, the goal of modern design-based stereology is to provide an unbiased estimate of the absolute number or size of measured objects within a three-dimensional region of interest, as opposed to a relative value (e.g., number of objects per unit …

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  • PWG

    Pathology Working Groups (PWG) Conducted by EPL

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    A Pathology Working Group (PWG) is a specialized type of review composed of a group of expert pathologists convened to answer specific questions and provide an independent unbiased opinion regarding study results. They may be convened by study sponsors, consortiums, or government agencies. Members of …

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  • EPL Pathology Peer Review

    Pathology Peer Review

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    The main purpose of a Pathology Peer Review is to improve the quality of the pathology data and narrative.  This can be achieved in several ways.  A peer review can help to ensure that the data are presented in a manner that meets the requirements …

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