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Category Archive for: ‘EPL Services’

  • On-Time Pathology Reporting

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    It is every client’s desire and expectation that their study report will be completed “On-Time” or better yet, be available ahead of schedule. There are a number of factors that determine whether a pathology report will be early, on time, or in the worst case …

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  • EXPEDITED SCHEDULING OF HISTOLOGY AND HISTOPATHOLOGY

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    Kerry Crabb, HTL(ASCP), is the Manager of North Carolina Laboratory Operations at EPL. Kerry joined EPL in 2015, and brought with him over 25 years of experience in managing histology laboratories. Kerry’s experience at both large pharmaceutical and agrochemical companies gave him a broad knowledge …

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  • Immunohistochemical Assay Optimization – Tackling Intrinsic Study Variables

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    Immunohistochemistry (IHC) is employed routinely for investigative and diagnostic evaluations of antigen-antibody interactions within cells or tissues. While most IHC target antigens are proteins, other antigenic biological substrates can also be recognized by antibodies (e.g., carbohydrates, lipids, or nucleic acids). Accurate and reproducible results are …

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  • EPL Histology – Tissue Accountability and Routine Recut Procedures

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    Since 1971, EPL has developed and refined methods to provide high quality and efficient histopathology services. The following information details some of the steps taken during histology processing and preparation at EPL, to ensure tissue accountability and define routine tissue recut procedures. Tissue Accountability on …

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  • Information List for EPL’s Unique Pathology Peer Review System

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    In 2017, EPL has conducted 189 pathology peer reviews, including 28 peer reviews on 2-year carcinogenicity studies and transgenic rasH2 mouse 26-week carcinogenicity projects.  Each project requires set up of our unique peer review system ahead of the actual peer review conduct. Our PQA software …

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  • Histology – How to Ensure the Quickest Possible Timeline

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    With the processing of up to 50,000 tissues per month, and projects regularly flowing in and out of our labs, histology scheduling at EPL is a continual process. Recognizing that the project timeline, in addition to quality and expertise, is one of the most important …

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  • EPL Pathology Peer Review

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    When selecting a Pathology Peer Review provider, experience is an important factor to consider in order to ensure high quality pathology data.  Over the last two years alone, EPL has conducted more than 250 pathology peer reviews.  These pathology peer reviews have been conducted internationally, …

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  • Get to Know Aclairo

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    Aclairo® Pharmaceutical Development Group, Inc. is committed to delivering independent and objective nonclinical and regulatory advice to the pharmaceutical industry. Every member of Aclairo’s staff strives to provide our clients with superior advice, analysis, work product and program assistance.  Aclairo’s unique experience and capabilities help our …

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  • 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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